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A Study of Tucatinib and Trastuzumab in People With Rectal Cancer

NCT05672524 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2026-05-12

No results posted yet for this study

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

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).

Sponsors & Collaborators

Principal Investigators

  • Andrea Cercek, MD · Memorial Sloan Kettering Cancer

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-30
Primary Completion
2027-07-30
Completion
2030-07-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05672524 on ClinicalTrials.gov