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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/NCT05498597
Registration number
NCT05498597
Ethics application status
Date submitted
10/08/2022
Date registered
12/08/2022
Date last updated
19/10/2023
Titles & IDs
Public title
AMT-151 in Patients With Selected Advanced Solid Tumours
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Scientific title
First-in-Human, Phase 1 Study of AMT-151, an Anti-Folate Receptor Alpha Antibody-Drug Conjugate, in Patients With Selected Advanced Solid Tumours
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Secondary ID [1]
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AMT-151-01
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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:
Condition category
Condition code
Cancer
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Non melanoma skin cancer
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Cancer
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0
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Kidney
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Cancer
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0
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Womb (Uterine or endometrial cancer)
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Cancer
0
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0
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Breast
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Cancer
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0
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Lung - Mesothelioma
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Cancer
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Ovarian and primary peritoneal
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Cancer
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Lung - Non small cell
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Cancer
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Other cancer types
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - AMT-151
Experimental: AMT-151 Dose Escalation -
Treatment: Drugs: AMT-151
Administered intravenously
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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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Recommended Phase 2 Dose (RP2D)
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Assessment method [1]
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The RP2D will be determined using dose limiting toxicities (DLTs) and all other available study data
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Timepoint [1]
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Up to 24 months
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Primary outcome [2]
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Maximum Tolerated Dose (MTD)
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Assessment method [2]
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The MTD will be determined using DLTs
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Timepoint [2]
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Up to 24 months
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Primary outcome [3]
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Incidence of Adverse Events
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Assessment method [3]
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Safety and tolerability profile assessed by the Common Terminology Criteria for Adverse Events v5.0
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Timepoint [3]
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Up to 24 months
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Secondary outcome [1]
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Overall Response Rate (ORR) according to the Response Evaluation Criteria in Solid Tumours (RECIST) v1.1
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Assessment method [1]
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Proportion of patients achieving Complete Response (CR) or Partial Response (PR)
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Timepoint [1]
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Up to 24 months
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Secondary outcome [2]
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Disease Control Rate (DCR) according to the RECIST v1.1
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Assessment method [2]
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Proportion of patients achieving CR, PR or Stable Disease (SD)
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Timepoint [2]
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Up to 24 months
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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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Time from date of start of treatment to date of the first progression or death, whichever occurs first.
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Timepoint [3]
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Up to 24 months
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Secondary outcome [4]
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Time to Treatment Response (TTR)
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Assessment method [4]
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Time from date of start of treatment to date of the first assessment of response (PR or CR)
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Timepoint [4]
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Up to 24 months
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Secondary outcome [5]
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Duration of Response (DoR)
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Assessment method [5]
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Time from date of first assessment of response (CR or PR) to date of the first progression or death, whichever occurs first
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Timepoint [5]
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Up to 24 months
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Secondary outcome [6]
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Overall Survival (OS)
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Assessment method [6]
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Time from date of start of treatment to date of death
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Timepoint [6]
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Up to 24 months
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Secondary outcome [7]
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Concentration of anti-drug antibodies (ADA)
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Assessment method [7]
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Immunogenicity profile characterized by concentration of ADAs
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Timepoint [7]
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Up to 24 months
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Secondary outcome [8]
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Maximum observed concentration (C[max])
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Assessment method [8]
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Pharmacokinetic profile characterized by the maximum observed concentration (C[max]) of AMT-151
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Timepoint [8]
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Up to 24 months
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Secondary outcome [9]
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Area under the curve (AUC)
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Assessment method [9]
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Pharmacokinetic profile characterized by the area under the curve (AUC) of AMT-151
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Timepoint [9]
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Up to 24 months
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Secondary outcome [10]
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Terminal half-life (t[1/2])
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Assessment method [10]
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Pharmacokinetic profile characterized by the terminal half-life (t[1/2]) of AMT-151
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Timepoint [10]
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Up to 24 months
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Secondary outcome [11]
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Time to maximum concentration (Tmax)
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Assessment method [11]
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Pharmacokinetic profile characterized by the time to maximum concentration (Tmax) of AMT-151
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Timepoint [11]
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Up to 24 months
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Eligibility
Key inclusion criteria
Key
- Patients must be willing and able to sign the Informed Consent Form, and to adhere to
the study visit schedule and other protocol requirements.
- Age =18 years (at the time consent is obtained).
- Patients with the following histologically confirmed, advanced cancer diagnoses:
1. Serous, endometrioid, clear-cell, or mucinous epithelial ovarian cancer,
fallopian tube cancer, or primary peritoneal cancer.
2. Serous, endometrioid, or clear-cell endometrial cancer.
3. Adenocarcinoma of the lung.
4. Triple-negative breast cancer.
5. Pancreatic ductal adenocarcinoma.
6. Malignant pleural mesothelioma.
- Patients who have undergone any number of prior systemic therapies and have
radiologically or clinically determined progressive disease during or after their most
recent line of therapy, and for whom no further standard therapy is available, or who
are intolerable to standard therapy.
- Patients must have at least one measurable or non-measurable lesion as per RECIST
version 1.1.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Adequate function of bone marrow, liver, kidneys, heart.
- Both male and female patients must agree to use effective contraceptive methods.
- Women of child-bearing potential (WCBP) must have a negative serum pregnancy test.
- Availability of tumour tissue sample (either an archival specimen or a fresh biopsy
material) at screening.
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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
- Prior treatment with any agent targeting Folate Receptor Alpha.
- Active central nervous system metastasis.
- Persistent toxicities from previous systemic anti-neoplastic treatments of Grade >1.
- Systemic anti-neoplastic therapy within five half-lives or 21 days, whichever is
shorter, prior to the first dose of the study drug.
- Radiotherapy to lung field at a total radiation dose of >= 20 Gy within 6 months,
wide-field radiotherapy (>30% of marrow-bearing bones) within 28 days, or focal
radiation for analgesic purpose or for lytic lesions at risk of fracture within 14
days prior to the first dose of the study drug, or no recovery from side effects of
such intervention.
- Major surgery (not including placement of vascular access device or tumor biopsies)
within 28 days prior to the first dose of the study drug, or no recovery from side
effects of such intervention.
- Prior allogeneic or autologous bone marrow transplantation.
- Significant cardiac or lung disease, active or chronic ocular disorders,
thromboembolic or cerebrovascular events within 6 months prior to the first dose of
the study drug, acute and/or clinically significant bacterial, fungal, or viral
infection.
- Pregnant or breast-feeding females.
Note: Other protocol defined Inclusion/Exclusion criteria apply.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
N/A
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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
Single group
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Other design features
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Phase
Phase 1
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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
25/01/2023
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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
30/10/2024
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Actual
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Sample size
Target
30
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
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Recruitment hospital [1]
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Chris O'Brien Lifehouse - Sydney
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Recruitment hospital [2]
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ICON Cancer Centre - Brisbane
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Recruitment hospital [3]
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Mater Cancer Care Centre - South Brisbane
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Recruitment hospital [4]
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Cancer Research SA - Adelaide
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Recruitment hospital [5]
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Cabrini Malvern Hospital - Malvern
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Recruitment hospital [6]
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One Clinical Research (OCR) - Perth
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Recruitment postcode(s) [1]
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- Sydney
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Recruitment postcode(s) [2]
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- Brisbane
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Recruitment postcode(s) [3]
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- South Brisbane
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Recruitment postcode(s) [4]
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- Adelaide
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Recruitment postcode(s) [5]
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- Malvern
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Recruitment postcode(s) [6]
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- Perth
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Recruitment outside Australia
Country [1]
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China
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State/province [1]
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Fujian
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Country [2]
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China
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State/province [2]
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Hunan
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Country [3]
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China
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State/province [3]
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Shanghai
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Multitude Therapeutics Inc.
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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 first-in-human study will evaluate the Maximum Tolerated Dose (MTD) / the Recommended Phase 2 Dose (RP2D), safety, tolerability, anti-tumor activity, pharmacokinetics, pharmacodynamics and immunogenicity of AMT-151, a novel antibody-drug conjugate against folate receptor alpha, in patients with selected advanced solid tumors.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05498597
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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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Sarwan Bishnoi
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Address
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Cancer Research SA
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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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Jane Zhu
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Address
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Country
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Phone
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13917933915
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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
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/ct2/show/NCT05498597
Download to PDF