Actively Recruiting
A Study of Tucatinib and Trastuzumab in People With Rectal Cancer
Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-05-12
37
Participants Needed
7
Research Sites
395 weeks
Total Duration
On this page
AI-Summary
What this Trial 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.
CONDITIONS
Official Title
A Study of Tucatinib and Trastuzumab in People With Rectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing and able to provide written informed consent for the trial.
- Be 18 years of age or older at the time of signing informed consent.
- ECOG performance status of 0 or 1.
- Histologically confirmed rectal adenocarcinoma.
- Adenocarcinoma with distal margin 15 cm or less from the anal verge, staged as cT3/cT4 N0 or cT(any) cN1/2.
- No evidence of distant metastases.
- Radiologically measurable or clinically evaluable disease.
- Confirmed HER2-positive rectal adenocarcinoma by CLIA-certified testing.
- Tumor specimen shows intact mismatch repair enzymes or microsatellite stability.
- Tumor specimen indicates RAS wild-type based on expanded RAS testing.
- Left ventricular ejection fraction of 50% or higher.
- Negative pregnancy test within 14 days before treatment for women of childbearing potential.
- Willingness to use adequate contraception during and 150 days after treatment if of childbearing potential.
- Nonchildbearing potential defined by age, amenorrhea status, or surgical sterilization.
- Adequate organ function within 14 days before treatment as defined by specific blood count and chemistry values.
You will not qualify if you...
- Recurrent rectal cancer.
- Prior pelvic radiation, chemotherapy, or surgery for rectal cancer.
- Tumor causing symptomatic bowel obstruction (temporary diverting ostomy allowed).
- Other invasive malignancy within 5 years except certain treated skin or cervical cancers.
- Active infection requiring systemic therapy.
- Use of other anticancer or experimental therapies during study treatment.
- Known HIV infection.
- Known active Hepatitis B or C infection.
- Any known chronic liver disease such as cirrhosis, NASH, or NAFLD.
- Women who are pregnant or breastfeeding, or men planning to conceive during the study period.
- Medical or psychiatric conditions that make participation inappropriate.
- Receipt of live vaccine within 30 days before study medication start.
- Major surgery, open biopsy, or significant injury within 28 days before enrollment.
- Inability to swallow pills or significant gastrointestinal disease affecting medication absorption.
- Use of strong CYP2C8 inhibitors not cleared or strong CYP3A4/CYP2C8 inducers within 5 days before first dose.
AI-Screening
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Trial Site Locations
Total: 7 locations
1
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, United States, 07920
Actively Recruiting
2
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, United States, 07748
Actively Recruiting
3
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, United States, 07645
Actively Recruiting
4
Memorial Sloan Kettering Cancer Center at Suffolk - Commack (Limited Protocol Activities)
Commack, New York, United States, 11725
Actively Recruiting
5
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, United States, 10604
Actively Recruiting
6
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, United States, 10065
Actively Recruiting
7
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Uniondale, New York, United States, 11553
Actively Recruiting
Research Team
A
Andrea Cercek, MD
CONTACT
R
Rona Yaeger, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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