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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT05123482
Registration number
NCT05123482
Ethics application status
Date submitted
13/10/2021
Date registered
17/11/2021
Date last updated
27/11/2023
Titles & IDs
Public title
First in Human Study to Evaluate AZD8205 in Patients With Advanced or Metastatic Solid Malignancies
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Scientific title
A Phase I/IIa Multi-center, Open-label Master Protocol to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Antitumor Activity of AZD8205 in Participants With Advanced or Metastatic Solid Malignancies
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Secondary ID [1]
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2021-000736-66
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Secondary ID [2]
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D6900C00001
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Breast Cancer
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Biliary Tract Carcinoma
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Ovarian Cancer
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Endometrial Cancer
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Condition category
Condition code
Cancer
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Womb (Uterine or endometrial cancer)
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - AZD8205
Experimental: Sub-Study 1 AZD8205 Monotherapy - Sub-Study 1 has two parts:
Part A : The aim is to determine the safety, tolerability, Recommended Phase 2 Dose(RP2D), and/or the Maximum Tolerated Dose (MTD) of AZD8205.
Part B: The aim of dose expansion is to evaluate anti-tumor activity of AZD8205 as monotherapy in select solid tumors.
Treatment: Drugs: AZD8205
AZD8205 is an antibody drug conjugate that has the potential to treat a wide variety of solid tumors including but not limited to breast cancer, Biliary Tract Cancer, ovarian, and endometrial cancers
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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The number of patients with adverse events
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Assessment method [1]
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Number of patients with adverse events by system organ class and preferred term
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Timepoint [1]
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From time of Informed consent to 30 days post last dose (approximately 1 year).
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Primary outcome [2]
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The number of patients with serious adverse events
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Assessment method [2]
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Number of patients with serious adverse events by system organ class and preferred term
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Timepoint [2]
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From time of Informed consent to 30 days post last dose (approximately 1 year)
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Primary outcome [3]
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The number of patients with dose-limiting toxicity (DLT), as defined in the protocol.
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Assessment method [3]
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A DLT is defined as any toxicity that occurs from the first dose of study treatment up to and including the planned end of Cycle 1 (the DLT assessment period) that is assessed as unrelated to the disease or disease-related processes under investigation and which includes pre-defined haematological and non-haematological toxicities.
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Timepoint [3]
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From first dose of study treatment until the end of Cycle 1 (approximately 21 days).
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Primary outcome [4]
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The number of patients with changes from baseline laboratory findings, ECGs and vital signs
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Assessment method [4]
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Description of laboratory findings and vital signs variables over time including change from baseline.
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Timepoint [4]
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From time of informed consent to 30 days post last dose (approximately 1 year)
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Secondary outcome [1]
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Objective Response Rate (ORR)
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Assessment method [1]
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The percentage of patients with a confirmed investigator assessed complete or partial response according to response criteria in solid tumours (RECIST 1.1).
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Timepoint [1]
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From first dose of AZD8205 to progressive disease or death in the absence of disease progression ( approx. 2 years )
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Secondary outcome [2]
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Duration of response (DoR)
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Assessment method [2]
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The time from the date of first response until date of disease progression or death in the absence of disease progression.
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Timepoint [2]
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From the first documented response to confirmed progressive disease or death ( approx. 2 years )
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Secondary outcome [3]
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Progression free Survival (PFS)
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Assessment method [3]
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The time from first dose until RECIST 1.1 defined disease progression or cessation of study treatment.
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Timepoint [3]
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From first dose of AZD8205 to progressive disease or death in the absence of disease progression ( approx. 2 years )
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Secondary outcome [4]
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Disease Control Rate at 12 weeks (DCR-12)
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Assessment method [4]
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Percentage of patients with confirmed CR or PR or having SD maintained for >= 11 weeks from first dose.
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Timepoint [4]
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Measured from first dose until progression. For each patient, this is expected to be at 12 weeks
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Secondary outcome [5]
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Overall Survival (OS)
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Assessment method [5]
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The time from the date of the first dose of study treatment until death due to any cause.
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Timepoint [5]
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From first dose of AZD8205 to death ( approx. 2 years )
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Secondary outcome [6]
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Pharmacokinetics of AZD8205: Area Under the concentration-time curve (AUC)
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Assessment method [6]
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Area under the plasma concentration-time curve
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Timepoint [6]
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From the first dose of study intervention, at predefined intervals throughout the administration of AZD8205 ( approx 2 years )
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Secondary outcome [7]
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Pharmacokinetics of AZD8205: Maximum plasma concentration of the study drug (Cmax)
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Assessment method [7]
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Maximum observed plasma concentration of the study drug
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Timepoint [7]
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From the first dose of study intervention, at predefined intervals throughout the administration of AZD8205 ( approx 2 years )
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Secondary outcome [8]
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Pharmacokinetics of AZD8205: Time to maximum plasma concentration of the study drug (T-max)
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Assessment method [8]
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Time to maximum observed plasma concentration of the study drug
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Timepoint [8]
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From the first dose of study intervention, at predefined intervals throughout the administration of AZD8205 ( approx 2 years )
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Secondary outcome [9]
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Pharmacokinetics of AZD8205: Clearance
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Assessment method [9]
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A pharmacokinetic measurement of the volume of plasma from which the study drug is completely removed per unit time.
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Timepoint [9]
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From the first dose of study intervention, at predefined intervals throughout the administration of AZD8205 ( approx 2 years )
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Secondary outcome [10]
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Pharmacokinetics of AZD8205: Terminal elimination half-life (t 1/2)
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Assessment method [10]
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Terminal elimination half life.
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Timepoint [10]
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From the first dose of study intervention, at predefined intervals throughout the administration of AZD8205 ( approx 2 years )
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Secondary outcome [11]
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Immunogenicity of AZD8205.
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Assessment method [11]
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The number and percentage of participants who develop ADAs.
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Timepoint [11]
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From the first dose of study intervention, at predefined intervals throughout the administration of AZD8205 ( approx 2 years )
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Eligibility
Key inclusion criteria
Key
- Age = 18 years
- Relapsed/metastatic solid tumors treated with prior adequate standard of care therapy
for tumor type and stage of disease or where in the opinion of the Investigator, a
clinical trial is the best option for the next treatment based on response and/or
tolerability to prior therapy.
- Measurable disease per RECIST v1.1
- Eastern Cooperative Oncology Group (ECOG) Performance Status: 0-1
- Life expectancy = 12 weeks
- Adequate organ and marrow function as defined in the protocol
For Sub-Study 1 Part A:
• Histologically or cytologically confirmed metastatic or locally advanced/recurrent breast
cancer, ovarian cancer, BTC or endometrial cancer
For Sub-Study 1 Part B:
- Histologically or cytologically confirmed metastatic or locally advanced and recurrent
disease for the respective cohort:
1. Cohort B1 (Biliary Tract Cancer)
2. Cohort B2 (Ovarian Cancer)
3. Cohort B3 (Breast Cancer)
4. Cohort B4 (Endometrial Cancer)
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Treatment with any of the following:
1. Nitrosourea or mitomycin C within 6 weeks prior to the first dose of study
treatment
2. Any investigational agents or study drugs from a previous clinical study within 5
half-lives or 28 days (whichever is shorter) prior to the first dose of study
treatment
3. Any other anticancer treatment within the following time periods prior to the
first dose of study intervention:
1. Cytotoxic treatment: 21 days
2. Non-cytotoxic drugs: 21 days or 5 half-lives (whichever is shorter)
3. Biological products including immuno-oncology agents: 28 days
- Spinal cord compression or a history of leptomeningeal carcinomatosis.
- Brain metastases unless treated, asymptomatic, stable, and not requiring continuous
corticosteroids at a dose of > 10 mg prednisone/day or equivalent for at least 4 weeks
prior to start of study.
- Active infection including tuberculosis and HBV, HCV or HIV
- History of (non-infectious) ILD/pneumonitis that required steroids, has current
ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at
screening.
- Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses
- Participants with any of the following cardiac criteria:
1. History of arrhythmia which is symptomatic or requires treatment (NCI CTCAE v5.0
Grade 3); symptomatic or uncontrolled atrial fibrillation, or asymptomatic
sustained ventricular tachycardia.
2. Uncontrolled hypertension.
3. Acute coronary syndrome/acute myocardial infarction, unstable angina pectoris,
coronary intervention procedure with percutaneous coronary intervention, or
coronary artery bypass grafting within 6 months.
4. History of brain perfusion problems (eg, carotid stenosis) or stroke, or
transient ischemic attack in the last 6 months prior to screening.
5. Symptomatic heart failure (NYHA class = 2).
6. Prior or current cardiomyopathy.
7. Severe valvular heart disease.
8. Mean resting QTcF > 470 msec.
9. Risk factors for QTc prolongation or risk of arrhythmic events such as heart
failure, congenital long QT syndrome, family history of long QT syndrome or
unexplained sudden death under 40 years of age.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Other
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Other design features
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Phase
Phase 1/Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
18/10/2021
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
30/06/2025
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Actual
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Sample size
Target
248
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Research Site - Melbourne
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Recruitment hospital [2]
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Research Site - Nedlands
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Recruitment hospital [3]
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Research Site - South Brisbane
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Recruitment postcode(s) [1]
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VIC 3000 - Melbourne
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Recruitment postcode(s) [2]
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6009 - Nedlands
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Recruitment postcode(s) [3]
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4101 - South Brisbane
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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California
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Country [2]
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United States of America
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State/province [2]
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Florida
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Country [3]
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United States of America
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State/province [3]
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Maryland
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Country [4]
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United States of America
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State/province [4]
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Massachusetts
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Country [5]
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United States of America
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State/province [5]
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Missouri
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Country [6]
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United States of America
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State/province [6]
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New Mexico
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Country [7]
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United States of America
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State/province [7]
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New York
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Country [8]
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United States of America
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State/province [8]
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North Carolina
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Country [9]
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United States of America
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State/province [9]
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Pennsylvania
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Country [10]
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United States of America
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State/province [10]
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Texas
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Country [11]
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Belgium
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State/province [11]
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Anderlecht
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Country [12]
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Belgium
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State/province [12]
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Leuven
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Country [13]
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Canada
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State/province [13]
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Alberta
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Country [14]
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Canada
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State/province [14]
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British Columbia
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Country [15]
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Canada
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State/province [15]
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Ontario
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Country [16]
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Canada
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State/province [16]
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Quebec
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Country [17]
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China
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State/province [17]
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Beijing
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Country [18]
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China
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State/province [18]
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Changsha
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Country [19]
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China
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State/province [19]
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Chongqing
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Country [20]
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China
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State/province [20]
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Guangzhou
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Country [21]
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Hungary
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State/province [21]
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Budapest
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Country [22]
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Japan
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State/province [22]
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Chuo-ku
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Japan
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State/province [23]
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Kashiwa
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Country [24]
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Japan
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State/province [24]
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Koto-ku
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Japan
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State/province [25]
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Sunto-gun
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Country [26]
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Korea, Republic of
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State/province [26]
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Seoul
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Country [27]
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Netherlands
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State/province [27]
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Amsterdam
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Country [28]
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Poland
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State/province [28]
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Warszawa
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Country [29]
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Spain
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State/province [29]
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Barcelona
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Country [30]
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Spain
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State/province [30]
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L'Hospitalet de Llobregat
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Country [31]
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Spain
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State/province [31]
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Málaga
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Country [32]
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Spain
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State/province [32]
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Pamplona
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Country [33]
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Taiwan
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State/province [33]
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Tainan
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Country [34]
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Taiwan
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State/province [34]
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Taipei
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Country [35]
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Taiwan
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State/province [35]
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Taoyuan
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Country [36]
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Thailand
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State/province [36]
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Bangkok
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Country [37]
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Thailand
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State/province [37]
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Chiang Mai
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Country [38]
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United Kingdom
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State/province [38]
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Cambridge
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Country [39]
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United Kingdom
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State/province [39]
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Cardiff
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Country [40]
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United Kingdom
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State/province [40]
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London
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
AstraZeneca
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This research study is studying a new compound, AZD8205, as a possible treatment for advanced
or metastatic solid tumours
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05123482
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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AstraZeneca Clinical Study Information Center
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Address
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Country
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Phone
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1-877-240-9479
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05123482
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