OncoMatch/Clinical Trials/NCT05672524
A Study of Tucatinib and Trastuzumab in People With Rectal Cancer
Is NCT05672524 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Trastuzumab and Tucatinib for adenocarcinoma of the rectum.
Treatment: Trastuzumab · Tucatinib — The study researchers believe that a combination of the drugs trastuzumab and tucatinib, given with standard chemotherapy (capecitabine and oxaliplatin/FOLFOX), may help participants with rectal cancer.
Check if I qualifyExtracted eligibility criteria
Cancer type
Colorectal Cancer
Biomarker criteria
Required: HER2 (ERBB2) overexpression (3+ immunohistochemistry [IHC]) (3+ IHC)
HER2+ overexpression (3+ immunohistochemistry [IHC]) by an FDA-approved HER2 IHC test
Required: HER2 (ERBB2) amplification by in situ hybridization (FISH or CISH)
HER2 2+ IHC is eligible if the tumor is amplified by an FDA-approved HER2 in situ hybridization assay (FISH or chromogenic in situ hybridization [CISH])
Required: HER2 (ERBB2) amplification by NGS
HER2 (ERBB2) amplification by CLIA-certified Next Generation Sequencing (NGS) sequencing assay
Required: KRAS wild-type
Tumor specimen that indicates RAS wild-type based on expanded RAS testing including KRAS exon 2 (codons 12 and 13), exon 3 (codons 59 and 61), and exon 4 (codons 117 and 146)
Required: NRAS wild-type
Tumor specimen that indicates RAS wild-type based on expanded RAS testing
Disease stage
Required: Stage CT3/CT4 N0, CT(ANY) CN1/2
Adenocarcinoma with distal margin of 15 cm or less from the anal verge on endoscopy, staged with endorectal ultrasound (ERUS) or magnetic resonance imaging (MRI) as cT3/cT4 N0 or cT(any) cN1/2
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: pelvic radiation therapy
Prior pelvic radiation therapy
Cannot have received: chemotherapy
Prior...chemotherapy for rectal cancer
Cannot have received: surgery
Prior...surgery for rectal cancer
Lab requirements
Blood counts
ANC ≥1,500 /mm3; Platelets ≥100,000 / mcL; Hemoglobin >9 g/dL or ≥5.6 mmol/L
Kidney function
Serum creatinine ≤1.5 × ULN OR CrCl ≥60 mL/min for creatinine >1.5 × ULN
Liver function
Serum total bilirubin ≤ 1.5 × ULN (except Gilbert's disease); AST (SGOT) and ALT (SGPT): ≤ 2.5 × ULN
Cardiac function
Left ventricular ejection fraction ≥50% assessed by echocardiography
Demonstrate adequate organ function as defined in the Table 6-1 below within 14 days of Cycle 1 Day 1, all screening labs should be performed within 14 days of treatment initiation.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) · Basking Ridge, New Jersey
- Memorial Sloan Kettering Monmouth (Limited Protocol Activities) · Middletown, New Jersey
- Memorial Sloan Kettering Bergen (Limited Protocol Activities) · Montvale, New Jersey
- Memorial Sloan Kettering Cancer Center at Suffolk - Commack (Limited Protocol Activities) · Commack, New York
- Memorial Sloan Kettering Westchester (Limited Protocol Activities) · Harrison, New York
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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