A Phase 2 Study of T-DXd in Patients With Selected HER2 Expressing Tumors
DPT02
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)
3 other identifiers
interventional
477
17 countries
89
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Aug 2020
Longer than P75 for phase_2
89 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 20, 2020
CompletedFirst Posted
Study publicly available on registry
July 22, 2020
CompletedStudy Start
First participant enrolled
August 18, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 23, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 23, 2027
April 9, 2026
April 1, 2026
6.6 years
July 20, 2020
April 8, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (9)
Duration of response (DoR)
An average of approximately 6 months
Disease control rate (DCR)
An average of approximately 6 months
Progression free survival (PFS)
An average of approximately 6 months
Proportion of patients alive and progression-free at 6 months and 12 months
Up to 12 months
Overall survival (OS)
An average of approximately 14 months
- +4 more secondary outcomes
Study Arms (12)
Part 1 Cohort 1
EXPERIMENTALBiliary tract cancer
Part 1 Cohort 2
EXPERIMENTALBladder cancer
Part 1 Cohort 3
EXPERIMENTALCervical cancer
Part 1 Cohort 4
EXPERIMENTALEndometrial cancer
Part 1 Cohort 5
EXPERIMENTALOvarian cancer
Part 1 Cohort 6
EXPERIMENTALPancreatic cancer
Part 1 Cohort 7
EXPERIMENTALRare tumors
Part 2 Cohort A
EXPERIMENTALAny tumor type that is HER2 IHC 3+ (excluding breast, gastric cancer, and colorectal cancer)
Part 2 Cohort B
EXPERIMENTALAny tumor type that is HER2 IHC 2+/ISH+ (excluding breast, gastric cancer, and colorectal cancer)
Part 2 Cohort C
EXPERIMENTALHER2 IHC 2+ or 1+ endometrial cancer
Part 2 Cohort D
EXPERIMENTALHER2 IHC 2+ or 1+ ovarian cancer
Part 2 Cohort E
EXPERIMENTALHER2 IHC 2+ or 1+ cervical cancer
Interventions
Trastuzumab deruxtecan by intravenous infusion
Eligibility Criteria
You may qualify if:
- Locally advanced, unresectable, or metastatic disease based on most recent imaging.
- 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.
- 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.
- +5 more criteria
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
- Daiichi Sankyo Co., Ltd.collaborator
Study Sites (89)
Research Site
Duarte, California, 91010, United States
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Santa Rosa, California, 95403, United States
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Chicago, Illinois, 60637, United States
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Muncie, Indiana, 47303, United States
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Boston, Massachusetts, 02215, United States
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Middletown, New Jersey, 07748, United States
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Harrison, New York, 10604, United States
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New York, New York, 10029, United States
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New York, New York, 10065, United States
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Durham, North Carolina, 27710, United States
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Houston, Texas, 77030, United States
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Seattle, Washington, 98195, United States
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Auchenflower, 4066, Australia
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Blacktown, 2148, Australia
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Camperdown, 2050, Australia
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Heidelberg, 3084, Australia
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Melbourne, 3000, Australia
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Nedlands, 6009, Australia
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Brussels, 1090, Belgium
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Leuven, 3000, Belgium
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Liège, 4000, Belgium
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Porto Alegre, 90035-000, Brazil
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São Paulo, 01246-000, Brazil
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Vitória, 29043-272, Brazil
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Kelowna, British Columbia, V1Y 5L3, Canada
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Ottawa, Ontario, K1H 8L6, Canada
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Québec, Quebec, G1J 1Z4, Canada
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Montreal, H3T 1E2, Canada
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Brno, 656 53, Czechia
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Hradec Králové, 500 05, Czechia
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Olomouc, 77900, Czechia
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Prague, 150 06, Czechia
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Prague, 180 81, Czechia
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Delhi, 110085, India
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Gūrgaon, 122001, India
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Kolkata, 700160, India
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Mumbai, 400012, India
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Milan, 20162, Italy
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Milan, 20141, Italy
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Naples, 80131, Italy
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Rome, 168, Italy
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Chūōku, 104-0045, Japan
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Kashiwa, 277-8577, Japan
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Suita-shi, 565-0871, Japan
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Amsterdam, 1066CX, Netherlands
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Delft, 2625 AD, Netherlands
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Groningen, 9700, Netherlands
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Bydgoszcz, 85-796, Poland
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Gdansk, 80-952, Poland
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Krakow, 31-501, Poland
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Poznan, 60-355, Poland
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Warsaw, 02-781, Poland
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Kaluga, 248007, Russia
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Moscow, 115419, Russia
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Moscow, 115478, Russia
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Moscow, 117997, Russia
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Moscow, 121205, Russia
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Moscow, 143423, Russia
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Moscow, 143442, Russia
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Saint Petersburg, 195271, Russia
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Saint Petersburg, 197758, Russia
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Seoul, 03080, South Korea
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Seoul, 03722, South Korea
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Seoul, 06351, South Korea
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Seoul, 5505, South Korea
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Barcelona, 8035, Spain
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Córdoba, 14004, Spain
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Madrid, 28027, Spain
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Madrid, 28040, Spain
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Madrid, 28041, Spain
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Madrid, 28046, Spain
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Valencia, 46014, Spain
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Taichung, 40705, Taiwan
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Tainan, 736, Taiwan
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Taipei, 100, Taiwan
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Taipei, 10449, Taiwan
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Taipei, 11217, Taiwan
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Taoyuan District, 333, Taiwan
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Bangkok, 10210, Thailand
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Bangkok, 10330, Thailand
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Bangkok, 10400, Thailand
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Chiang Mai, 50200, Thailand
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Hat Yai, 90110, Thailand
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Khon Kaen, 40002, Thailand
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Muang, 50200, Thailand
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Ongkharak, 26120, Thailand
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London, SW2 6JJ, United Kingdom
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Manchester, M20 4BX, United Kingdom
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Sutton, SM2 5PT, United Kingdom
Related Publications (2)
Oaknin A, Lee JY, Makker V, Oh DY, Banerjee S, Gonzalez-Martin A, Jung KH, Lugowska I, Manso L, Manzano A, Melichar B, Siena S, Stroyakovskiy D, Fielding A, Puvvada S, Smith A, Meric-Bernstam F. Efficacy of Trastuzumab Deruxtecan in HER2-Expressing Solid Tumors by Enrollment HER2 IHC Status: Post Hoc Analysis of DESTINY-PanTumor02. Adv Ther. 2024 Nov;41(11):4125-4139. doi: 10.1007/s12325-024-02975-x. Epub 2024 Sep 11.
PMID: 39261417DERIVEDMeric-Bernstam F, Makker V, Oaknin A, Oh DY, Banerjee S, Gonzalez-Martin A, Jung KH, Lugowska I, Manso L, Manzano A, Melichar B, Siena S, Stroyakovskiy D, Fielding A, Ma Y, Puvvada S, Shire N, Lee JY. Efficacy and Safety of Trastuzumab Deruxtecan in Patients With HER2-Expressing Solid Tumors: Primary Results From the DESTINY-PanTumor02 Phase II Trial. J Clin Oncol. 2024 Jan 1;42(1):47-58. doi: 10.1200/JCO.23.02005. Epub 2023 Oct 23.
PMID: 37870536DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Masking Details
- This study is Open-Label Study.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 20, 2020
First Posted
July 22, 2020
Study Start
August 18, 2020
Primary Completion (Estimated)
March 23, 2027
Study Completion (Estimated)
March 23, 2027
Last Updated
April 9, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.