NCT07407465

Upfront Trastuzumab-Deruxtecan Plus Capecitabine and Bevacizumab for Patients With HER-2 Positive Metastatic Colorectal Cancer.

Phase II Single Arm Study of Upfront Trastuzumab-Deruxtecan Plus Capecitabine and Bevacizumab for Patients With HER-2 Positive Metastatic Colorectal Cancer: the CHIMERA Study.

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 42 (estimated)
• Sponsor: Gruppo Oncologico del Nord-Ovest · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to evaluate the activity of first-line trastuzumab-deruxtecan, capecitabine and bevacizumab in terms of overall response rate for patients with HER-2 positive metastatic/locally advanced unresectable colorectal cancer

Detailed description

This is a multinational, Open-label, Single-arm Phase II trial in which patients with metastatic or locally advanced unresectable HER-2 positive colorectal cancer will receive upfront trastuzumab-deruxtecan, capecitabine and bevacizumab until progressive disease, unacceptable toxicity, consent withdrawal, investigator's decision or study termination, whichever occurs first. The primary endpoint of the study is Overall Response Rate by blinded independent central review. In order to preliminarily assess safety, a safety run-in phase will be conducted. The safety run-in phase will include the first 6 patients enrolled. After 6 patients will have received 3 cycles of study treatment, enrollment will be interrupted. A Safety Monitoring Committee (SMC) will review safety data (including demographics, adverse events, serious adverse events, adverse events of special interest, and relevant laboratory data). The SMC will then provide a recommendation as to whether the study may continue, whether amendment(s) to the protocol should be implemented, or whether the study should be stopped. Recruitment will only be resumed accordingly to SMC decision.

Conditions

• Colorectal Cancer
• Colorectal Adenocarcinoma
• Rectal Adenocarcinoma
• Rectal Cancer, Adenocarcinoma
• Rectal Cancer, Metastatic
• Colon Cancer Metastatic
• Colon Cancer Adenocarcinoma

Interventions

Type	Name	Description
DRUG	Trastuzumab-Deruxtecan (T-DXd)	T-DXd at the dose of 5.4 mg/kg intravenous (as a 90 +/- 10 minute infusion) on day 1 every 3 weeks
DRUG	Capecitabine	1000 mg/sqm bis in die (BID) orally on days 1-14 every 3 weeks
DRUG	Bevacizumab	7.5 mg/kg intravenous (as a 30 minute infusion) on day 1 every 3 weeks

Timeline

• Start date: 2025-10-20
• Primary completion: 2027-10-20
• Completion: 2027-10-20
• First posted: 2026-02-12
• Last updated: 2026-02-17

Locations

28 sites across 4 countries: France, Germany, Italy, Spain