NCT05672524

A Study of Tucatinib and Trastuzumab in People With Rectal Cancer

A Phase II Study of Induction Tucatinib and Trastuzumab With Total Neoadjuvant Therapy for Locally Advanced HER2-amplified Rectal Adenocarcinoma

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 37 (estimated)
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Adenocarcinoma of the Rectum
• Locally Advanced Rectal Adenocarcinoma
• Rectal Adenocarcinoma
• HER2 Positive Rectal Adenocarcinoma
• Rectal Cancer

Interventions

Type	Name	Description
DRUG	Trastuzumab	Patients will then be given tucatinib (300 mg BID orally) and trastuzumab (8 mg/kg on day 1, then 6 mg/kg starting cycle 2 and every three weeks) therapy for an initial 6 week lead-in period. All patients, regardless of findings on rectal MRI will then transition to standard of care induction chemotherapy with continuation of the trastuzumab and tucatinib for a total of five additional cycles (15 extra weeks).
DRUG	Tucatinib	Patients will then be given tucatinib (300 mg BID orally) and trastuzumab (8 mg/kg on day 1, then 6 mg/kg starting cycle 2 and every three weeks) therapy for an initial 6 week lead-in period. All patients, regardless of findings on rectal MRI will then transition to standard of care induction chemotherapy with continuation of the trastuzumab and tucatinib for a total of five additional cycles (15 extra weeks).

Timeline

• Start date: 2022-12-30
• Primary completion: 2027-07-30
• Completion: 2030-07-31
• First posted: 2023-01-05
• Last updated: 2026-03-04

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated drug study