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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/NCT04482309
Registration number
NCT04482309
Ethics application status
Date submitted
20/07/2020
Date registered
22/07/2020
Date last updated
22/05/2024
Titles & IDs
Public title
A Phase 2 Study of T-DXd in Patients With Selected HER2 Expressing Tumors
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Scientific title
A Phase 2, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of Trastuzumab Deruxtecan (T-DXd, DS-8201a) for the Treatment of Selected HER2 Expressing Tumors (DESTINY-PanTumor02)
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Secondary ID [1]
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2020-001574-29
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Secondary ID [2]
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D967VC00001
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Universal Trial Number (UTN)
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Trial acronym
DPT02
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Part 1: Bladder, Biliary Tract, Cervical, Endometrial, Ovarian, Pancreatic Cancer, Rare Tumors, Any Tumor Type Excluding Breast, Gastric, Colorectal Cancer
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Part 2: HER2 Expressing/Amplified Solid Tumors Excluding Breast, Gastric, Colorectal Cancer
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Condition category
Condition code
Cancer
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Bowel - Back passage (rectum) or large bowel (colon)
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Trastuzumab deruxtecan
Experimental: Part 1 Cohort 1 - Biliary tract cancer
Experimental: Part 1 Cohort 2 - Bladder cancer
Experimental: Part 1 Cohort 3 - Cervical cancer
Experimental: Part 1 Cohort 4 - Endometrial cancer
Experimental: Part 1 Cohort 5 - Ovarian cancer
Experimental: Part 1 Cohort 6 - Pancreatic cancer
Experimental: Part 1 Cohort 7 - Rare tumors
Experimental: Part 2 Cohort A - Any tumor type that is HER2 IHC 3+ (excluding breast, gastric cancer, and colorectal cancer)
Experimental: Part 2 Cohort B - Any tumor type that is HER2 IHC 2+/ISH+ (excluding breast, gastric cancer, and colorectal cancer)
Experimental: Part 2 Cohort C - HER2 IHC 2+ or 1+ endometrial cancer
Experimental: Part 2 Cohort D - HER2 IHC 2+ or 1+ ovarian cancer
Experimental: Part 2 Cohort E - HER2 IHC 2+ or 1+ cervical cancer
Treatment: Drugs: Trastuzumab deruxtecan
Trastuzumab deruxtecan by intravenous infusion
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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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Objective Response Rate (ORR)
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Assessment method [1]
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Confirmed ORR per RECIST 1.1 is the percentage of patients with Complete Response or Partial Response that is subsequently confirmed.
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Timepoint [1]
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An average of approximately 6 months
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Secondary outcome [1]
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Duration of response (DoR)
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Assessment method [1]
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DOR is defined as the time from the date of first documented response until the date of documented progression or death.
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Timepoint [1]
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An average of approximately 6 months
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Secondary outcome [2]
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Disease control rate (DCR)
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Assessment method [2]
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DCR is the percentage of subjects who have a best overall response of complete response (CR) or partial response (PR) or stable disease (SD).
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Timepoint [2]
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An average of approximately 6 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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PFS is the time from date of first dose of study treatment until the date of objective disease progression or death.
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Timepoint [3]
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An average of approximately 6 months
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Secondary outcome [4]
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Proportion of patients alive and progression-free at 6 months and 12 months
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Assessment method [4]
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The proportion of patients alive and progression-free at 6 and 12 months (Kaplan-Meier estimates).
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Timepoint [4]
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Up to 12 months
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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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OS is the time from date of first dose of study treatment until death due to any cause.
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Timepoint [5]
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An average of approximately 14 months
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Secondary outcome [6]
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Proportion of patients alive at 6 and 12 months
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Assessment method [6]
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The proportion of patients alive at 6 and 12 months (Kaplan-Meier estimates).
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Timepoint [6]
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Up to 12 months
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Secondary outcome [7]
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Occurrence of adverse events (AEs) and serious adverse events (SAEs)
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Assessment method [7]
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Occurrence of AEs and SAEs graded according to NCI CTCAE v5.0.
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Timepoint [7]
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An average of approximately 8 months
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Secondary outcome [8]
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Pharmacokinetics (PK) assessed by serum concentration of T-DXd, total anti-HER2 antibody and MAAA-1181
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Assessment method [8]
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Individual patient data and descriptive statistics will be provided for serum concentration data at each time point for T-DXd, total anti-HER2 antibody and MAAA-1181a
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Timepoint [8]
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An average of approximately 8 months
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Secondary outcome [9]
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The immunogenicity of T-DXd assessed by the presence of ADAs for T-DXd
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Assessment method [9]
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Individual participant data and descriptive statistics will be provided for data at each time point.
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Timepoint [9]
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An average of approximately 6 months
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Eligibility
Key inclusion criteria
- Locally advanced, unresectable, or metastatic disease based on most recent imaging.
- Part 1:The respective cohorts for patient inclusion are:
- Cohort 1: Biliary tract cancer
- Cohort 2: Bladder cancer
- Cohort 3: Cervical cancer
- Cohort 4: Endometrial cancer
- Cohort 5: Epithelial ovarian cancer
- Cohort 6: Pancreatic cancer
- Cohort 7: Rare tumors: This cohort will consist of patients with tumors that
express HER2, excluding the tumors mentioned above, and breast, non-small cell
lung cancer, gastric cancer, and colorectal cancer.
- Part 2:The respective cohorts for patient inclusion are:
- Cohort A: Metastatic or advanced solid tumors that are HER2 IHC 3+ (excluding
breast, gastric cancer, and colorectal cancer). Patients with non-small cell lung
cancer can be included.
- Cohort B: Metastatic or advanced solid tumors that are HER2 IHC 2+/ISH+ any tumor
type (excluding breast, gastric cancer, and colorectal cancer). Patients with
non-small cell lung cancer can be included.
- Cohort C: Metastatic or advanced solid endometrial cancer that is HER2 IHC 2+ or
1+.
- Cohort D: Metastatic or advanced ovarian cancer that is HER2 IHC 2+ or 1+.
- Cohort E: Metastatic or advanced solid cervical cancer that is HER2 IHC 2+ or 1+.
- Progressed following prior treatment or who have no satisfactory alternative treatment
option.
- Prior HER2 targeting therapy is permitted.
- HER2 expression scored using current ASCO/CAP guidelines for scoring HER2 for gastric
cancer.
- Part 1: IHC 3+ or IHC 2+ by local or central assessment
- Part 2: IHC and ISH results by central assessment as pre-defined for each cohort
- Has measurable target disease assessed by the Investigator based on RECIST version
1.1.
- Has protocol- defined adequate organ function including cardiac, renal and hepatic
function.
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Minimum age
18
Years
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Maximum age
120
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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
- History of non-infectious pneumonitis/ILD that required steroids, current ILD, or
where suspected ILD that cannot be ruled out by imaging at screening
- Lung-specific intercurrent clinically significant severe illnesses
- Uncontrolled infection requiring intravenous (IV) antibiotics, antivirals, or
antifungals
- Pleural effusion, ascites or pericardial effusion that requires drainage, peritoneal
shunt, or Cell-free and Concentrated Ascites Reinfusion Therapy (CART
- Known Somatic DNA mutation of HER2 (ERBB2) without tumoral HER2 protein expression.
- Primary diagnosis of adenocarcinoma of the breast, adenocarcinoma of the colon or
rectum, adenocarcinoma of the gastric body or gastro-esophageal junction, or non-small
cell lung cancer for Part 1. For Part 2, patients with primary diagnosis of
adenocarcinoma of the breast, adenocarcinoma of the colon or rectum, adenocarcinoma of
the gastric body or gastro-esophageal junction will be excluded.
- Medical conditions that may interfere with the subject's participation in the study.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised 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
Parallel
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Other design features
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Phase
Phase 2
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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
18/08/2020
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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
30/07/2027
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Actual
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Sample size
Target
468
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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 - Auchenflower
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Research Site - Blacktown
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Research Site - Camperdown
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Research Site - Heidelberg
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Research Site - Melbourne
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Research Site - Nedlands
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4066 - Auchenflower
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2148 - Blacktown
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2050 - Camperdown
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3084 - Heidelberg
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3000 - Melbourne
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Recruitment postcode(s) [6]
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6009 - Nedlands
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Recruitment outside Australia
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Northwood Middlesex
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Sutton
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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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Daiichi Sankyo Co., Ltd.
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Ethics approval
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Summary
Brief summary
This is an open-label, multi-center, multi-cohort, Phase 2 study to evaluate the efficacy and
safety of trastuzumab deruxtecan (T-DXd) for the treatment of selected HER2-expressing
tumors.
This study will consist of Part 1 which includes 7 cohorts of: urothelial bladder cancer,
biliary tract cancer, cervical cancer, endometrial cancer, ovarian cancer, pancreatic cancer,
and rare tumors; and Part 2 which includes 5 cohorts A to E of: A) any tumor type that is
HER2 IHC 3+ (excluding breast, gastric cancer, and colorectal cancer), B) any tumor type that
is HER2 IHC 2+/ISH+ (excluding breast, gastric cancer, and colorectal cancer), C) HER2 IHC 2+
or 1+ endometrial cancer, D) HER2 IHC 2+ or 1+ ovarian cancer, and E) HER2 IHC 2+ or 1+
cervical cancer.
Study hypothesis: Trastuzumab deruxtecan will show meaningful clinical activity and a
favorable risk benefit profile in selected HER2-expressing solid tumors.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04482309
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Contact person for public queries
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AstraZeneca Clinical Study Information Center
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1-877-240-9479
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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/NCT04482309
Download to PDF