TriangleNCT04482309 · CITED IN SOURCE DOCUMENTS
A Phase 2 Study of T-DXd in Patients With Selected HER2 Expressing Tumors
An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.
- Phase
- PHASE2
- Status at capture
- ACTIVE NOT RECRUITING
- Registry last update
- 2026-07-10
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.
Open the original ClinicalTrials.gov record → · Download preserved record
What did the study report?
Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.
No posted result sections were captured. Registered plans do not establish that a treatment works.
Who could take part
- eligibility Criteria
- 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. 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.
- healthy Volunteers
- false
- maximum Age
- 120 Years
- minimum Age
- 18 Years
- sex
- ALL
- std Ages
- ADULT
- OLDER_ADULT
Treatment arms and interventions
- arm Groups
- description
- Biliary tract cancer
- intervention Names
- Drug: Trastuzumab deruxtecan
- label
- Part 1 Cohort 1
- type
- EXPERIMENTAL
- description
- Bladder cancer
- intervention Names
- Drug: Trastuzumab deruxtecan
- label
- Part 1 Cohort 2
- type
- EXPERIMENTAL
- description
- Cervical cancer
- intervention Names
- Drug: Trastuzumab deruxtecan
- label
- Part 1 Cohort 3
- type
- EXPERIMENTAL
- description
- Endometrial cancer
- intervention Names
- Drug: Trastuzumab deruxtecan
- label
- Part 1 Cohort 4
- type
- EXPERIMENTAL
- description
- Ovarian cancer
- intervention Names
- Drug: Trastuzumab deruxtecan
- label
- Part 1 Cohort 5
- type
- EXPERIMENTAL
- description
- Pancreatic cancer
- intervention Names
- Drug: Trastuzumab deruxtecan
- label
- Part 1 Cohort 6
- type
- EXPERIMENTAL
- description
- Rare tumors
- intervention Names
- Drug: Trastuzumab deruxtecan
- label
- Part 1 Cohort 7
- type
- EXPERIMENTAL
- description
- Any tumor type that is HER2 IHC 3+ (excluding breast, gastric cancer, and colorectal cancer)
- intervention Names
- Drug: Trastuzumab deruxtecan
- label
- Part 2 Cohort A
- type
- EXPERIMENTAL
- description
- Any tumor type that is HER2 IHC 2+/ISH+ (excluding breast, gastric cancer, and colorectal cancer)
- intervention Names
- Drug: Trastuzumab deruxtecan
- label
- Part 2 Cohort B
- type
- EXPERIMENTAL
- description
- HER2 IHC 2+ or 1+ endometrial cancer
- intervention Names
- Drug: Trastuzumab deruxtecan
- label
- Part 2 Cohort C
- type
- EXPERIMENTAL
- description
- HER2 IHC 2+ or 1+ ovarian cancer
- intervention Names
- Drug: Trastuzumab deruxtecan
- label
- Part 2 Cohort D
- type
- EXPERIMENTAL
- description
- HER2 IHC 2+ or 1+ cervical cancer
- intervention Names
- Drug: Trastuzumab deruxtecan
- label
- Part 2 Cohort E
- type
- EXPERIMENTAL
- interventions
- arm Group Labels
- 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
- description
- Trastuzumab deruxtecan by intravenous infusion
- name
- Trastuzumab deruxtecan
- other Names
- DS-8201a
- T-DXd
- type
- DRUG
Study design
- allocation
- NON_RANDOMIZED
- intervention Model
- PARALLEL
- intervention 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 Info
- masking
- NONE
- masking Description
- This study is Open-Label Study.
- primary Purpose
- TREATMENT
Enrollment
- count
- 477
- type
- ACTUAL
Registered outcome plans (not posted results)
- primary Outcomes
- description
- Confirmed ORR per RECIST 1.1 is the percentage of patients with Complete Response or Partial Response that is subsequently confirmed.
- measure
- Objective Response Rate (ORR)
- time Frame
- An average of approximately 6 months
- secondary Outcomes
- description
- DOR is defined as the time from the date of first documented response until the date of documented progression or death.
- measure
- Duration of response (DoR)
- time Frame
- An average of approximately 6 months
- description
- DCR is the percentage of subjects who have a best overall response of complete response (CR) or partial response (PR) or stable disease (SD).
- measure
- Disease control rate (DCR)
- time Frame
- An average of approximately 6 months
- description
- PFS is the time from date of first dose of study treatment until the date of objective disease progression or death.
- measure
- Progression free survival (PFS)
- time Frame
- An average of approximately 6 months
- description
- The proportion of patients alive and progression-free at 6 and 12 months (Kaplan-Meier estimates).
- measure
- Proportion of patients alive and progression-free at 6 months and 12 months
- time Frame
- Up to 12 months
- description
- OS is the time from date of first dose of study treatment until death due to any cause.
- measure
- Overall survival (OS)
- time Frame
- An average of approximately 14 months
- description
- The proportion of patients alive at 6 and 12 months (Kaplan-Meier estimates).
- measure
- Proportion of patients alive at 6 and 12 months
- time Frame
- Up to 12 months
- description
- Occurrence of AEs and SAEs graded according to NCI CTCAE v5.0.
- measure
- Occurrence of adverse events (AEs) and serious adverse events (SAEs)
- time Frame
- An average of approximately 8 months
- description
- 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
- measure
- Pharmacokinetics (PK) assessed by serum concentration of T-DXd, total anti-HER2 antibody and MAAA-1181
- time Frame
- An average of approximately 8 months
- description
- Individual participant data and descriptive statistics will be provided for data at each time point.
- measure
- The immunogenicity of T-DXd assessed by the presence of ADAs for T-DXd
- time Frame
- An average of approximately 6 months
Full study description
- 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.
Source references
- references
- citation
- 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.
- pmid
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- type
- DERIVED
- citation
- 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
- 39261417
- type
- DERIVED
- citation
- Meric-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
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- type
- DERIVED
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- ure was duration of response (DOR). All outcomes were assessed by independent central review (ICR) based on RECIST v1.1. DESTINY-PanTumor02 DESTINY-PanTumor02 (NCT04482309) was a multicenter, multicohort, open-label trial that included 111 adult patients with locally advanced, unresectable, or metastatic HER2-positive (IHC 3+ by
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- rastuzumab deruxtecan in patients with HER2-expressing solid tumors.</p> <div class="pdq-content-list"><ol id="_612"><li>The <a href="/clinicaltrials/NCT04482309">DESTINY-PanTumor02</a> trial (NCT04482309), reported in abstract form, was tumor-agnostic (enrolled patients with HER2-positive tumors from any site) but incl
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- dq-content-list"><ul id="_613"><li>The overall response rate was 22% in this subset of patients.</li></ul></div></li><li> The phase II <a href="/clinicaltrials/NCT04482309">HERB</a> trial (NCT04482309) enrolled 32 patients (24 with HER2-positive disease, 8 with HER2-low disease) with biliary tract cancers refractory to, or intole
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- "><li>The overall response rate was 22% in this subset of patients.</li></ul></div></li><li> The phase II <a href="/clinicaltrials/NCT04482309">HERB</a> trial (NCT04482309) enrolled 32 patients (24 with HER2-positive disease, 8 with HER2-low disease) with biliary tract cancers refractory to, or intolerant of, a gemcitabine-conta
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Preserved source evidence · Independent clinical review pending · Not medical advice