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 (Jun 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
Treatments studied
Targeted therapy
Chemotherapy
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.
Frequently asked questions
Is NCT07407465 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Does this trial require ERBB2?
Yes, ERBB2 overexpression is a required biomarker for enrollment.
Does this trial require ERBB2?
Yes, ERBB2 amplification is a required biomarker for enrollment.
Does this trial require KRAS?
Yes, KRAS known status is a required biomarker for enrollment.
Are patients with DPYD alterations eligible?
No. DPYD 2a (c.1905+1G>A) polymorphism is an exclusion criterion.
Are patients with DPYD alterations eligible?
No. DPYD 13 (c.1679 T>G) polymorphism is an exclusion criterion.
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