Part 1: Bladder, Biliary Tract, Cervical, Endometrial, Ovarian, Pancreatic Cancer, Rare Tumors, Any Tumor Type Excluding Breast, Gastric, Colorectal CancerPhase 2DPT02NCT04482309
A Phase 2 Study of T-DXd in Patients With Selected HER2 Expressing Tumors
A Phase 2 study testing Trastuzumab deruxtecan in people with Part 1: Bladder, Biliary Tract, Cervical, Endometrial, Ovarian, Pancreatic Cancer, Rare Tumors, Any Tumor Type Excluding Breast, Gastric, Colorectal Cancer and Part 2: HER2 Expressing/Amplified Solid Tumors Excluding Breast, Gastric, Colorectal Cancer, run by AstraZeneca at 89 sites in 17 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Part 1: Bladder, Biliary Tract, Cervical, Endometrial, Ovarian, Pancreatic Cancer, Rare Tumors, Any Tumor Type Excluding Breast, Gastric, Colorectal Cancer, Part 2: HER2 Expressing/Amplified Solid Tumors Excluding Breast, Gastric, Colorectal Cancer
- What is being tested?
- Trastuzumab deruxtecan
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 477 participants
- Where
- 89 sitesin 17 countries
- Study dates
- 18 Aug 2020to 23 Mar 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 22Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
89 sites in 17 countries.
89 sites in 17 countries
United States12 sites
Research Site
Boston, Massachusetts, 02215
Research Site
Chicago, Illinois, 60637
Research Site
Duarte, California, 91010
Research Site
Durham, North Carolina, 27710
Research Site
Harrison, New York, 10604
Research Site
Houston, Texas, 77030
Research Site
Middletown, New Jersey, 07748
Research Site
Muncie, Indiana, 47303
Research Site
New York, New York, 10029
Research Site
New York, New York, 10065
Research Site
Santa Rosa, California, 95403
Research Site
Seattle, Washington, 98195
Russia9 sites
Research Site
Kaluga, 248007
Research Site
Moscow, 115419
Research Site
Moscow, 115478
Research Site
Moscow, 117997
Research Site
Moscow, 121205
Research Site
Moscow, 143423
Research Site
Moscow, 143442
Research Site
Saint Petersburg, 195271
Research Site
Saint Petersburg, 197758
Thailand8 sites
Research Site
Bangkok, 10210
Research Site
Bangkok, 10330
Research Site
Bangkok, 10400
Research Site
Chiang Mai, 50200
Research Site
Hat Yai, 90110
Research Site
Khon Kaen, 40002
Research Site
Muang, 50200
Research Site
Ongkharak, 26120
Spain7 sites
Research Site
Barcelona, 8035
Research Site
Córdoba, 14004
Research Site
Madrid, 28027
Research Site
Madrid, 28040
Research Site
Madrid, 28041
Research Site
Madrid, 28046
Research Site
Valencia, 46014
Australia6 sites
Research Site
Auchenflower, 4066
Research Site
Blacktown, 2148
Research Site
Camperdown, 2050
Research Site
Heidelberg, 3084
Research Site
Melbourne, 3000
Research Site
Nedlands, 6009
Taiwan6 sites
Research Site
Taichung, 40705
Research Site
Tainan, 736
Research Site
Taipei, 100
Research Site
Taipei, 10449
Research Site
Taipei, 11217
Research Site
Taoyuan, 333
Czechia5 sites
Research Site
Brno, 656 53
Research Site
Hradec Králové, 500 05
Research Site
Olomouc, 77900
Research Site
Prague, 150 06
Research Site
Prague, 180 81
Poland5 sites
Research Site
Bydgoszcz, 85-796
Research Site
Gdansk, 80-952
Research Site
Krakow, 31-501
Research Site
Poznan, 60-355
Research Site
Warsaw, 02-781
Canada4 sites
Research Site
Kelowna, British Columbia, V1Y 5L3
Research Site
Montreal, H3T 1E2
Research Site
Ottawa, Ontario, K1H 8L6
Research Site
Québec, Quebec, G1J 1Z4
India4 sites
Research Site
Delhi, 110085
Research Site
Gūrgaon, 122001
Research Site
Kolkata, 700160
Research Site
Mumbai, 400012
Italy4 sites
Research Site
Milan, 20162
Research Site
Milan, 20141
Research Site
Naples, 80131
Research Site
Rome, 168
South Korea4 sites
Research Site
Seoul, 03080
Research Site
Seoul, 03722
Research Site
Seoul, 06351
Research Site
Seoul, 5505
Belgium3 sites
Research Site
Brussels, 1090
Research Site
Leuven, 3000
Research Site
Liège, 4000
Brazil3 sites
Research Site
Porto Alegre, 90035-000
Research Site
São Paulo, 01246-000
Research Site
Vitória, 29043-272
Japan3 sites
Research Site
Chūōku, 104-0045
Research Site
Kashiwa, 277-8577
Research Site
Suita-shi, 565-0871
Netherlands3 sites
Research Site
Amsterdam, 1066CX
Research Site
Delft, 2625 AD
Research Site
Groningen, 9700
United Kingdom3 sites
Research Site
London, SW2 6JJ
Research Site
Manchester, M20 4BX
Research Site
Sutton, SM2 5PT
About this study
Official 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)
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.
- Conditions
- Part 1: Bladder, Biliary Tract, Cervical, Endometrial, Ovarian, Pancreatic Cancer, Rare Tumors, Any Tumor Type Excluding Breast, Gastric, Colorectal Cancer, Part 2: HER2 Expressing/Amplified Solid Tumors Excluding Breast, Gastric, Colorectal Cancer
- Being tested
- Trastuzumab deruxtecan
- Keywords
- T-DXd, DS-8201a, Trastuzumab Deruxtecan, HER2
- Medical subject headings
- Pancreatic Neoplasms, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trastuzumab deruxtecanDrug
Also called DS-8201a, T-DXd
Trastuzumab deruxtecan by intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| Part 1 Cohort 1 | Experimental | Biliary tract cancer Receives: Drug: Trastuzumab deruxtecan |
| Part 1 Cohort 2 | Experimental | Bladder cancer Receives: Drug: Trastuzumab deruxtecan |
| Part 1 Cohort 3 | Experimental | Cervical cancer Receives: Drug: Trastuzumab deruxtecan |
| Part 1 Cohort 4 | Experimental | Endometrial cancer Receives: Drug: Trastuzumab deruxtecan |
| Part 1 Cohort 5 | Experimental | Ovarian cancer Receives: Drug: Trastuzumab deruxtecan |
| Part 1 Cohort 6 | Experimental | Pancreatic cancer Receives: Drug: Trastuzumab deruxtecan |
| Part 1 Cohort 7 | Experimental | Rare tumors Receives: Drug: Trastuzumab deruxtecan |
| Part 2 Cohort A | Experimental | Any tumor type that is HER2 IHC 3+ (excluding breast, gastric cancer, and colorectal cancer) Receives: Drug: Trastuzumab deruxtecan |
| Part 2 Cohort B | Experimental | Any tumor type that is HER2 IHC 2+/ISH+ (excluding breast, gastric cancer, and colorectal cancer) Receives: Drug: Trastuzumab deruxtecan |
| Part 2 Cohort C | Experimental | HER2 IHC 2+ or 1+ endometrial cancer Receives: Drug: Trastuzumab deruxtecan |
| Part 2 Cohort D | Experimental | HER2 IHC 2+ or 1+ ovarian cancer Receives: Drug: Trastuzumab deruxtecan |
| Part 2 Cohort E | Experimental | HER2 IHC 2+ or 1+ cervical cancer Receives: Drug: Trastuzumab deruxtecan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: An average of approximately 6 months
Secondary outcomes (9)
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.
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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
Measured: 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.
Measured: An average of approximately 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2020
- Study start18 Aug 2020
- Primary completion23 Mar 2027 (estimated)
- Study completion23 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Part 1: Bladder, Biliary Tract, Cervical, Endometrial, Ovarian, Pancreatic Cancer, Rare Tumors, Any Tumor Type Excluding Breast, Gastric, Colorectal CancerStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 477 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Daiichi Sankyo Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04482309
- Sponsor's protocol ID
- D967VC00001
- Other IDs
- 2023-504721-39-02, 2020-001574-29, 2023
- Acronym
- DPT02
- Status last verified
- Oct 2026
- First submitted
- 20 Jul 2020
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Lee JY, Oaknin A, Manso L, Gonzalez-Martin A, Lugowska I, Lorusso D, Banerjee S, Liao JB, Lu CH, Prasongsook N, Melichar B, Anoka C, Jung L, Michelini F, Puvvada S, Meric-Bernstam F, Makker V. Trastuzumab deruxtecan in HER2-expressing gynecologic cancers from DESTINY-PanTumor02: antitumor activity, safety, and exploratory biomarker analyses. J Gynecol Oncol. 2026 May;37(3):e65. doi: 10.3802/jgo.2026.37.e65. Epub 2026 May 6.
PubMed 42135959Oaknin 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.
PubMed 39261417Meric-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.
PubMed 37870536
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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)
- ClinicalTrials.gov ID
- NCT04482309
- Acronym / sponsor ID
- DPT02 / D967VC00001
- Conditions
- Part 1: Bladder, Biliary Tract, Cervical, Endometrial, Ovarian, Pancreatic Cancer, Rare Tumors, Any Tumor Type Excluding Breast, Gastric, Colorectal Cancer, Part 2: HER2 Expressing/Amplified Solid Tumors Excluding Breast, Gastric, Colorectal Cancer
- Keywords
- T-DXd, DS-8201a, Trastuzumab Deruxtecan, HER2
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 477 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Daiichi Sankyo Co., Ltd.
- Study start
- 18 Aug 2020 (actual)
- Primary completion
- 23 Mar 2027 (estimated)
- Study completion
- 23 Mar 2027 (estimated)
- First posted
- 22 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 12
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Part 1 Cohort 1 | Experimental | Drug: Trastuzumab deruxtecanBiliary tract cancer |
| Part 1 Cohort 2 | Experimental | Drug: Trastuzumab deruxtecanBladder cancer |
| Part 1 Cohort 3 | Experimental | Drug: Trastuzumab deruxtecanCervical cancer |
| Part 1 Cohort 4 | Experimental | Drug: Trastuzumab deruxtecanEndometrial cancer |
| Part 1 Cohort 5 | Experimental | Drug: Trastuzumab deruxtecanOvarian cancer |
| Part 1 Cohort 6 | Experimental | Drug: Trastuzumab deruxtecanPancreatic cancer |
| Part 1 Cohort 7 | Experimental | Drug: Trastuzumab deruxtecanRare tumors |
| Part 2 Cohort A | Experimental | Drug: Trastuzumab deruxtecanAny tumor type that is HER2 IHC 3+ (excluding breast, gastric cancer, and colorectal cancer) |
| Part 2 Cohort B | Experimental | Drug: Trastuzumab deruxtecanAny tumor type that is HER2 IHC 2+/ISH+ (excluding breast, gastric cancer, and colorectal cancer) |
| Part 2 Cohort C | Experimental | Drug: Trastuzumab deruxtecanHER2 IHC 2+ or 1+ endometrial cancer |
| Part 2 Cohort D | Experimental | Drug: Trastuzumab deruxtecanHER2 IHC 2+ or 1+ ovarian cancer |
| Part 2 Cohort E | Experimental | Drug: Trastuzumab deruxtecanHER2 IHC 2+ or 1+ cervical cancer |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Locally advanced, unresectable, or metastatic disease based on most recent imaging.
- Part 1:The respective cohorts for patient inclusion are:
- Part 2:The respective cohorts for patient inclusion are:
- Progressed following prior treatment or who have no satisfactory alternative treatment option.
- Prior HER2 targeting therapy is permitted.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trastuzumab deruxtecanAlso: DS-8201a, T-DXdTrastuzumab deruxtecan by intravenous infusion | Drug | Part 1 Cohort 1, Part 1 Cohort 2, Part 1 Cohort 3, Part 1 Cohort 4, Part 1 Cohort 5, Part 1 Cohort 6, Part 1 Cohort 7, Part 2 Cohort A, Part 2 Cohort B, Part 2 Cohort C, Part 2 Cohort D, Part 2 Cohort E |
Primary outcome
Objective Response Rate (ORR)
Time frame: An average of approximately 6 months
Confirmed ORR per RECIST 1.1 is the percentage of patients with Complete Response or Partial Response that is subsequently confirmed.
9 secondary outcomes
Duration of response (DoR)
Time frame: An average of approximately 6 months
Disease control rate (DCR)
Time frame: An average of approximately 6 months
Progression free survival (PFS)
Time frame: An average of approximately 6 months
Proportion of patients alive and progression-free at 6 months and 12 months
Time frame: Up to 12 months
Overall survival (OS)
Time frame: An average of approximately 14 months
Proportion of patients alive at 6 and 12 months
Time frame: Up to 12 months
Occurrence of adverse events (AEs) and serious adverse events (SAEs)
Time frame: An average of approximately 8 months
Pharmacokinetics (PK) assessed by serum concentration of T-DXd, total anti-HER2 antibody and MAAA-1181
Time frame: An average of approximately 8 months
The immunogenicity of T-DXd assessed by the presence of ADAs for T-DXd
Time frame: An average of approximately 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Derived from this study: PubMed 42135959Lee JY, Oaknin A, Manso L, Gonzalez-Martin A, Lugowska I, Lorusso D, Banerjee S, Liao JB, Lu CH, Prasongsook N, Melichar B, Anoka C, Jung L, Michelini F, Puvvada S, Meric-Bernstam F, Makker V. Trastuzumab deruxtecan in HER2-expressing gynecologic cancers from DESTINY-PanTumor02: antitumor activity, safety, and exploratory biomarker analyses. J Gynecol Oncol. 2026 May;37(3):e65. doi: 10.3802/jgo.2026.37.e65. Epub 2026 May 6.
- Derived from this study: PubMed 39261417Oaknin 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.
- Derived from this study: PubMed 37870536Meric-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.
- Individual participant dataSharing planned: Yes. 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
89 sites in 17 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Trastuzumab deruxtecan in people with Part 1: Bladder, Biliary Tract, Cervical, Endometrial, Ovarian, Pancreatic Cancer, Rare Tumors, Any Tumor Type Excluding Breast, Gastric, Colorectal Cancer and Part 2: HER2 Expressing/Amplified Solid Tumors Excluding Breast, Gastric, Colorectal Cancer, run by AstraZeneca at 89 sites in 17 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 22 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 89 sites in United States, Russia, Thailand, Spain, Australia and 12 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) (time frame: An average of approximately 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04482309, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.