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New drug cocktail targets Hard-to-Treat HER2 cancers

NCT ID NCT04704661

First seen Nov 01, 2025 · Last updated Jun 19, 2026 · Updated 37 times

Summary

This early-phase trial is testing whether combining the targeted drug trastuzumab deruxtecan (DS-8201a) with an experimental pill called ceralasertib can safely treat advanced solid tumors that have a HER2 mutation. The study has two parts: first, finding the safest dose in 51 patients with various cancers; second, comparing the combo against DS-8201a alone in colorectal and gastroesophageal cancers. The goal is to see if blocking a DNA repair enzyme with ceralasertib makes the chemotherapy more effective.

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This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.

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Contacts and locations

Locations

  • Huntsman Cancer Institute/University of Utah

    Salt Lake City, Utah, 84112, United States

  • Los Angeles General Medical Center

    Los Angeles, California, 90033, United States

  • Memorial Hospital East

    Shiloh, Illinois, 62269, United States

  • NYP/Weill Cornell Medical Center

    New York, New York, 10065, United States

  • National Cancer Institute Developmental Therapeutics Clinic

    Bethesda, Maryland, 20892, United States

  • National Institutes of Health Clinical Center

    Bethesda, Maryland, 20892, United States

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210, United States

  • Siteman Cancer Center at Christian Hospital

    St Louis, Missouri, 63136, United States

  • Siteman Cancer Center at Saint Peters Hospital

    City of Saint Peters, Missouri, 63376, United States

  • Siteman Cancer Center at West County Hospital

    Creve Coeur, Missouri, 63141, United States

  • Siteman Cancer Center-South County

    St Louis, Missouri, 63129, United States

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania, 19107, United States

  • UC Irvine Health/Chao Family Comprehensive Cancer Center

    Orange, California, 92868, United States

  • UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care

    Irvine, California, 92612, United States

  • UF Health Cancer Institute - Gainesville

    Gainesville, Florida, 32610, United States

  • USC / Norris Comprehensive Cancer Center

    Los Angeles, California, 90033, United States

  • UT MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • UT Southwestern/Simmons Cancer Center-Dallas

    Dallas, Texas, 75390, United States

  • University of California Davis Comprehensive Cancer Center

    Sacramento, California, 95817, United States

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104, United States

  • University of Texas Medical Branch

    Galveston, Texas, 77555-0565, United States

  • University of Texas at Austin

    Austin, Texas, 78712, United States

  • Washington University School of Medicine

    St Louis, Missouri, 63110, United States

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance

trastuzumab deruxtecan (DS-8201a) and ceralasertib (AZD6738)

What this could lead to

If successful, this could lead to a new combination treatment option for advanced HER2-positive cancers that have stopped responding to standard therapy.

What could go wrong

This is a very early Phase 1 trial with only 51 participants, so safety and dosing are still being figured out. The combination may cause significant side effects or fail to shrink tumors in many patients.

Conditions

The condition(s) this trial relates to.

breast cancer breast carcinoma breast neoplasm cancer carcinosarcoma colonic neoplasm colorectal neoplasm endometrium neoplasm gastric cancer gastric carcinoma gastric neoplasm gastroesophageal junction adenocarcinoma Neoplasm Metastasis salivary gland cancer salivary gland carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

ADVANCED BREAST CARCINOMA ADVANCED COLON CARCINOMA ADVANCED COLORECTAL CARCINOMA ADVANCED ENDOMETRIAL CARCINOMA ADVANCED ENDOMETRIAL CARCINOMA ADVANCED GASTRIC CARCINOMA ADVANCED GASTROESOPHAGEAL JUNCTION ADENOCARCINOMA ADVANCED MALIGNANT SOLID NEOPLASM ADVANCED SALIVARY GLAND CARCINOMA ANATOMIC STAGE III BREAST CANCER AJCC V8 ANATOMIC STAGE III BREAST CANCER AJCC V8 ANATOMIC STAGE IV BREAST CANCER AJCC V8 CLINICAL STAGE III GASTRIC CANCER AJCC V8 CLINICAL STAGE III GASTRIC CANCER AJCC V8 CLINICAL STAGE III GASTROESOPHAGEAL JUNCTION ADENOCARCINOMA AJCC V8 CLINICAL STAGE III GASTROESOPHAGEAL JUNCTION ADENOCARCINOMA AJCC V8 CLINICAL STAGE IV GASTRIC CANCER AJCC V8 CLINICAL STAGE IV GASTRIC CANCER AJCC V8 CLINICAL STAGE IV GASTROESOPHAGEAL JUNCTION ADENOCARCINOMA AJCC V8 CLINICAL STAGE IV GASTROESOPHAGEAL JUNCTION ADENOCARCINOMA AJCC V8 HER2 POSITIVE BREAST CARCINOMA MALIGNANT HEPATOBILIARY NEOPLASM METASTATIC BREAST CARCINOMA METASTATIC COLON CARCINOMA METASTATIC COLORECTAL CARCINOMA METASTATIC ENDOMETRIAL CARCINOMA METASTATIC GASTRIC CARCINOMA METASTATIC GASTROESOPHAGEAL JUNCTION ADENOCARCINOMA METASTATIC MALIGNANT SOLID NEOPLASM METASTATIC SALIVARY GLAND CARCINOMA STAGE III COLON CANCER AJCC V8 STAGE III COLON CANCER AJCC V8 STAGE III COLORECTAL CANCER AJCC V8 STAGE III COLORECTAL CANCER AJCC V8 STAGE III MAJOR SALIVARY GLAND CANCER AJCC V8 STAGE III MAJOR SALIVARY GLAND CANCER AJCC V8 STAGE III UTERINE CORPUS CARCINOMA OR CARCINOSARCOMA AJCC V8 STAGE III UTERINE CORPUS CARCINOMA OR CARCINOSARCOMA AJCC V8 STAGE III UTERINE CORPUS CARCINOMA OR CARCINOSARCOMA AJCC V8 STAGE IV COLON CANCER AJCC V8 STAGE IV COLON CANCER AJCC V8 STAGE IV COLORECTAL CANCER AJCC V8 STAGE IV COLORECTAL CANCER AJCC V8 STAGE IV MAJOR SALIVARY GLAND CANCER AJCC V8 STAGE IV MAJOR SALIVARY GLAND CANCER AJCC V8 STAGE IV UTERINE CORPUS CARCINOMA OR CARCINOSARCOMA AJCC V8 STAGE IV UTERINE CORPUS CARCINOMA OR CARCINOSARCOMA AJCC V8 UNRESECTABLE BREAST CARCINOMA UNRESECTABLE COLON CARCINOMA UNRESECTABLE COLORECTAL CARCINOMA UNRESECTABLE ENDOMETRIAL CARCINOMA UNRESECTABLE GASTRIC CARCINOMA UNRESECTABLE GASTROESOPHAGEAL JUNCTION ADENOCARCINOMA UNRESECTABLE MALIGNANT SOLID NEOPLASM UNRESECTABLE SALIVARY GLAND CARCINOMA