NCT05672524 · Memorial Sloan Kettering Cancer Center
A Study of Tucatinib and Trastuzumab in People With Rectal Cancer
What this study is about
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.
View original scientific description
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.
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).
Primary outcome measures
Clinical complete response of study participants
Time frame: 21 +/- 4 weeks
The primary objective of this trial is to determine the clinical complete response rate after the completion of initial neoadjuvant tucatinib and trastuzumab followed by standard of care induction chemotherapy (assessed around week 21 ± 4 weeks) in subjects with HER2-positive, RAS wild-type locally advanced rectal adenocarcinoma
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Willing and able to provide written informed consent for the trial.
- Be ≥18 years of age on the date of signing informed consent.
- ECOG performance status of 0 or 1.
- Histologically confirmed rectal adenocarcinoma.
- 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,
- No evidence of distant metastases
- Radiologically measurable or clinically evaluable disease per Protocol Section 13.0.
- Have confirmed HER2-positive rectal adenocarcinoma, as defined by having tumor tissue tested at a Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory, meeting at least one of the following criteria: 1. HER2+ overexpression (3+ immunohistochemistry \[IHC\]) by an FDA-approved HER2 IHC test following the package insert's interpretational manual for gastric cancer 2. HER2 2+ IHC is eligible if the tumor is amplifi
Where
- Basking Ridge, New Jersey
- Middletown, New Jersey
- Montvale, New Jersey
- Commack, New York
- Harrison, New York
- New York, New York
- Uniondale, New York
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 12, 2026 · Source of record for eligibility and locations