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2020-08-18
2027-07-30
2027-07-30
468
NCT04482309
AstraZeneca
AstraZeneca
INTERVENTIONAL
A Phase 2 Study of T-DXd in Patients With Selected HER2 Expressing Tumors
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.
N/A
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2020-07-20 | N/A | 2025-08-25 |
2020-07-20 | N/A | 2025-08-26 |
2020-07-22 | N/A | 2025-08 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Non Randomized
Interventional Model:
Parallel
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: Part 1 Cohort 1 Biliary tract cancer | DRUG: Trastuzumab deruxtecan
|
| EXPERIMENTAL: Part 1 Cohort 2 Bladder cancer | DRUG: Trastuzumab deruxtecan
|
| EXPERIMENTAL: Part 1 Cohort 3 Cervical cancer | DRUG: Trastuzumab deruxtecan
|
| EXPERIMENTAL: Part 1 Cohort 4 Endometrial cancer | DRUG: Trastuzumab deruxtecan
|
| EXPERIMENTAL: Part 1 Cohort 5 Ovarian cancer | DRUG: Trastuzumab deruxtecan
|
| EXPERIMENTAL: Part 1 Cohort 6 Pancreatic cancer | DRUG: Trastuzumab deruxtecan
|
| EXPERIMENTAL: Part 1 Cohort 7 Rare tumors | DRUG: Trastuzumab deruxtecan
|
| EXPERIMENTAL: Part 2 Cohort A Any tumor type that is HER2 IHC 3+ (excluding breast, gastric cancer, and colorectal cancer) | DRUG: Trastuzumab deruxtecan
|
| EXPERIMENTAL: Part 2 Cohort B Any tumor type that is HER2 IHC 2+/ISH+ (excluding breast, gastric cancer, and colorectal cancer) | DRUG: Trastuzumab deruxtecan
|
| EXPERIMENTAL: Part 2 Cohort C HER2 IHC 2+ or 1+ endometrial cancer | DRUG: Trastuzumab deruxtecan
|
| EXPERIMENTAL: Part 2 Cohort D HER2 IHC 2+ or 1+ ovarian cancer | DRUG: Trastuzumab deruxtecan
|
| EXPERIMENTAL: Part 2 Cohort E HER2 IHC 2+ or 1+ cervical cancer | DRUG: Trastuzumab deruxtecan
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | Confirmed ORR per RECIST 1.1 is the percentage of patients with Complete Response or Partial Response that is subsequently confirmed. | An average of approximately 6 months |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Duration of response (DoR) | DOR is defined as the time from the date of first documented response until the date of documented progression or death. | An average of approximately 6 months |
| Disease control rate (DCR) | DCR is the percentage of subjects who have a best overall response of complete response (CR) or partial response (PR) or stable disease (SD). | An average of approximately 6 months |
| Progression free survival (PFS) | PFS is the time from date of first dose of study treatment until the date of objective disease progression or death. | An average of approximately 6 months |
| Proportion of patients alive and progression-free at 6 months and 12 months | The proportion of patients alive and progression-free at 6 and 12 months (Kaplan-Meier estimates). | Up to 12 months |
| Overall survival (OS) | OS is the time from date of first dose of study treatment until death due to any cause. | An average of approximately 14 months |
| Proportion of patients alive at 6 and 12 months | The proportion of patients alive at 6 and 12 months (Kaplan-Meier estimates). | Up to 12 months |
| Occurrence of adverse events (AEs) and serious adverse events (SAEs) | Occurrence of AEs and SAEs graded according to NCI CTCAE v5.0. | An average of approximately 8 months |
| Pharmacokinetics (PK) assessed by serum concentration of T-DXd, total anti-HER2 antibody and MAAA-1181 | 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 | An average of approximately 8 months |
| The immunogenicity of T-DXd assessed by the presence of ADAs for T-DXd | Individual participant data and descriptive statistics will be provided for data at each time point. | An average of approximately 6 months |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: AstraZeneca Clinical Study Information Center Phone Number: 1-877-240-9479 Email: information.center@astrazeneca.com |
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
