Experimental combo targets Hard-to-Treat HER2 cancers

NCT ID NCT04704661

Ongoing Disease control Sponsor: National Cancer Institute (NCI) Source: ClinicalTrials.gov ↗

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-phase trial is testing a combination of two drugs—trastuzumab deruxtecan (a targeted chemotherapy) and ceralasertib (a drug that may block cancer cell repair)—in people with advanced solid tumors that have a HER2 mutation. The study has two parts: first, finding the safest dose, and then comparing the combo against the single drug in colorectal and gastroesophageal cancers. About 51 participants are enrolled, and the main focus is on safety and early signs of tumor shrinkage.

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 treatment option for advanced HER2-positive cancers that have stopped responding to standard therapies.
What could go wrong: This is a very early (Phase 1) trial with only 51 participants, so the main goal is safety and dosing, not proof of effectiveness. The combination may cause significant side effects and may not work better than existing treatments.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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Conditions

The condition(s) this trial relates to.

breast cancer breast carcinoma breast neoplasm cancer carcinosarcoma colon carcinoma colonic neoplasm colorectal cancer colorectal carcinoma colorectal neoplasm endometrial carcinoma endometrium neoplasm gastric cancer gastric carcinoma gastric neoplasm gastroesophageal junction adenocarcinoma hepatobiliary neoplasm HER2 positive breast carcinoma major salivary gland cancer major salivary gland carcinoma malignant colon neoplasm metastatic malignant neoplasm metastatic malignant neoplasm in the colon neoplasm Neoplasm Metastasis salivary gland cancer salivary gland carcinoma uterine corpus cancer

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

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

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