OncoMatch/Clinical Trials/NCT07407465
Upfront Trastuzumab-Deruxtecan Plus Capecitabine and Bevacizumab for Patients With HER-2 Positive Metastatic Colorectal Cancer.
Is NCT07407465 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Trastuzumab-Deruxtecan (T-DXd) and Capecitabine for colorectal cancer.
Treatment: Trastuzumab-Deruxtecan (T-DXd) · Capecitabine · Bevacizumab — 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
Check if I qualifyExtracted eligibility criteria
Cancer type
Colorectal Cancer
Biomarker criteria
Required: HER2 (ERBB2) overexpression (IHC 3+ or 2+/ISH amplified)
Presence of locally determined HER2 overexpression/amplification defined as IHC 3+ or 2+/ISH amplified on archival/newly obtained tumor tissue, according to the American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) guidelines for gastric/gastroesophageal cancer.
Required: HER2 (ERBB2) amplification (IHC 3+ or 2+/ISH amplified)
Presence of locally determined HER2 overexpression/amplification defined as IHC 3+ or 2+/ISH amplified on archival/newly obtained tumor tissue, according to the American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) guidelines for gastric/gastroesophageal cancer.
Required: KRAS known status
Have RAS known status
Required: NRAS known status
Have RAS known status
Required: BRAF known status
Have RAS known status
Required: MMR proficient
pMMR/MSS status by standard local testing
Excluded: DPYD 2a (c.1905+1G>A) polymorphism
Presence of any of the following dihydropyrimidine dehydrogenase (DPYD) polymorphism, based on local laboratory testing: DPYD 2a (c.1905+1G>A); DPYD13 (c.1679 T>G); DPYD D949V (c.2846 A>T).
Excluded: DPYD 13 (c.1679 T>G) polymorphism
Presence of any of the following dihydropyrimidine dehydrogenase (DPYD) polymorphism, based on local laboratory testing: DPYD 2a (c.1905+1G>A); DPYD13 (c.1679 T>G); DPYD D949V (c.2846 A>T).
Excluded: DPYD D949V (c.2846 A>T) polymorphism
Presence of any of the following dihydropyrimidine dehydrogenase (DPYD) polymorphism, based on local laboratory testing: DPYD 2a (c.1905+1G>A); DPYD13 (c.1679 T>G); DPYD D949V (c.2846 A>T).
Disease stage
Metastatic disease required
initially metastatic or unresectable locally advanced
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: systemic anticancer therapy
Exception: Subjects may have received prior fluoropyrimidine with or without oxaliplatin for CRC in the adjuvant or neoadjuvant setting if it was completed > 6 months before enrollment.
Have previously received any systemic anticancer therapy for CRC in the metastatic/locally advanced unresectable setting or have participated in any interventional clinical trial for CRC in the metastatic/locally advanced unresectable setting. Subjects may have received prior fluoropyrimidine with or without oxaliplatin for CRC in the adjuvant or neoadjuvant setting if it was completed > 6 months before enrollment.
Cannot have received: anti-HER2 agent
Have previously been treated with an anti-HER2 agent
Cannot have received: topoisomerase I inhibitor
Have previously been treated with ... a topoisomerase I inhibitor
Lab requirements
Blood counts
ANC ≥ 1500/mm3 (no G-CSF within 1 week prior to C1D1). Platelet count ≥ 100000/mm3 (no platelet transfusion within 1 week prior to C1D1). Hemoglobin ≥ 9.0 g/dL.
Kidney function
Creatinine clearance ≥ 60 mL/min as determined by Cockcroft-Gault (using actual body weight).
Liver function
Total bilirubin ≤ 1.5 x ULN or ≤ 3 x ULN in the presence of documented Gilbert's Syndrome or liver metastases at baseline. AST and ALT ≤ 3 x ULN (≤ 5 x ULN if liver metastases are present). Serum albumin ≥ 2.5 g/dL.
Cardiac function
LVEF ≥ 50% within 28 days before enrollment. QTcF ≤ 470 msec (females) or ≤ 450 msec (males) based on average of the screening 12-lead ECG.
Have adequate hematological, hepatic, renal, cardiac and coagulation function, as defined below, obtained ≤ 7 days prior to enrollment (Cycle 1 Day 1): ... (see above for details)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify