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Clinical Trials in India / NCT04482309
Active, not recruiting Phase 2

A Phase 2 Study of T-DXd in Patients With Selected HER2 Expressing Tumors

NCT04482309 · tracked via the Priya Life Science India tracker
Sponsor
AstraZeneca
Phase
Phase 2
Started
2020-08-18
Last updated
2026-07-10

Condition(s) studied

Part 1: Bladder, Biliary Tract, Cervical, Endometrial, Ovarian, Pancreatic Cancer, Rare Tumors, Any Tumor Type Excluding Breast, Gastric, Colorectal CancerPart 2: HER2 Expressing/Amplified Solid Tumors Excluding Breast, Gastric, Colorectal Cancer

Investigational drug(s) / intervention(s)

Trastuzumab deruxtecan

Trastuzumab deruxtecan: Trastuzumab deruxtecan by intravenous infusion

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
120 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (89)

FacilityCityRegionStatus
Research Site Duarte California
Research Site Santa Rosa California
Research Site Chicago Illinois
Research Site Muncie Indiana
Research Site Boston Massachusetts
Research Site Middletown New Jersey
Research Site Harrison New York
Research Site New York New York
Research Site New York New York
Research Site Durham North Carolina
Research Site Houston Texas
Research Site Seattle Washington
Research Site Auchenflower Australia
Research Site Blacktown Australia
Research Site Camperdown Australia
Research Site Heidelberg Australia
Research Site Melbourne Australia
Research Site Nedlands Australia
Research Site Brussels Belgium
Research Site Leuven Belgium
Research Site Liège Belgium
Research Site Porto Alegre Brazil
Research Site São Paulo Brazil
Research Site Vitória Brazil
Research Site Kelowna British Columbia
Research Site Ottawa Ontario
Research Site Québec Quebec
Research Site Montreal Canada
Research Site Brno Czechia
Research Site Hradec Králové Czechia
Research Site Olomouc Czechia
Research Site Prague Czechia
Research Site Prague Czechia
Research Site Delhi India
Research Site Gurgaon India
Research Site Kolkata India
Research Site Mumbai India
Research Site Milan Italy
Research Site Milan Italy
Research Site Naples Italy

+ 49 more sites — see the full list on the official registry below.

On this site

📄 Enhertu (trastuzumab deruxtecan) drug profile →

More AstraZeneca trials in India

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04482309 on ClinicalTrials.gov ↗ ← All trials in India