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NCT04482309 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of 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, sponsored by AstraZeneca.

Recruiting
Registry status
Phase 2
Development phase
468
Enrollment target
20
Study locations

NCT04482309 is a Phase 2 study of 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 that is actively recruiting participants, run by AstraZeneca. The registered enrollment target is 468 participants. The trial reports 20 study locations across 12 states.

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The verdict

NCT04482309, a Phase 2 study of 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, is actively recruiting participants, sponsored by AstraZeneca.

RECRUITING
Registry status
Phase 2
Development phase
468 participants
Enrollment target
20
Study locations

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.

Conditions Studied

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

Interventions

  • DRUG Trastuzumab deruxtecan

Study Locations (20)

California

  • Research Site - Burbank
  • Research Site - Duarte
  • Research Site - Fullerton
  • Research Site - La Jolla
  • Research Site - Los Angeles
  • Research Site - Santa Rosa

New York

  • Research Site - Harrison
  • Research Site - New York
  • Research Site - New York
  • Research Site - Rochester

Illinois

  • Research Site - Chicago

Indiana

  • Research Site - Muncie

Massachusetts

  • Research Site - Boston

Michigan

  • Research Site - Detroit

Missouri

  • Research Site - St Louis

New Jersey

  • Research Site - Middletown

Trial Details

FieldValue
Enrollment Target 468 participants
Start Date 2020-08-18
Est. Completion 2027-07-30
Phase Phase 2

Sponsor

AstraZeneca

1,285 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04482309

The ClinicalTrials.gov registry entry for NCT04482309 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 468 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AstraZeneca, which has 1,285 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Part 1: Bladder, Biliary Tract, Cervical, Endometrial, Ovarian, Pancreatic Cancer, Rare Tumors, Any Tumor Type Excluding Breast, Gastric, Colorectal Cancer appearing as the primary indexed condition, and to 1 intervention - of which Trastuzumab deruxtecan is the first listed.

NCT04482309 reports 20 study locations spanning 12 distinct geographic areas - top geographies include California, New York, Illinois.

Frequently Asked Questions

What is clinical trial NCT04482309 about?

NCT04482309 is a clinical study titled "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...

What is the current status of trial NCT04482309?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 468 participants. The study started on 2020-08-18. Estimated completion is 2027-07-30.

What conditions does trial NCT04482309 study?

This clinical trial studies the following 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.

What interventions are being tested in trial NCT04482309?

The interventions under investigation include: Trastuzumab deruxtecan (DRUG).

Who is sponsoring clinical trial NCT04482309?

This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04482309 being conducted?

This trial has 20 study locations across California, Illinois, Indiana, Massachusetts, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Part 1: Bladder, Biliary Tract, Cervical, Endometrial, Ovarian, Pancreatic Cancer, Rare Tumors, Any Tumor Type Excluding Breast, Gastric, Colorectal Cancer

All registered trials for this condition

Part 2: HER2 Expressing/Amplified Solid Tumors Excluding Breast, Gastric, Colorectal Cancer

All registered trials for this condition

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.