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A Study of Tucatinib and Trastuzumab for HER2-Positive Rectal Cancer

This study is looking at whether a combination of two drugs, tucatinib and trastuzumab, along with standard chemotherapy, can help people with HER2-positive rectal adenocarcinoma (a type of rectal cancer). You might be able to join if you are at least 18 years old, have a confirmed diagnosis of rectal adenocarcinoma, and meet other health criteria. The researchers will measure how many participants have a "clinical complete response" (meaning no signs of cancer are found) after about 21 weeks. The study plans to enroll 37 people, but its current recruitment status is unclear.

Study design
This is an interventional study, meaning participants will receive specific treatments. It plans to enroll 37 participants.
What's involved
Participants will receive tucatinib orally twice a day and trastuzumab intravenously (through a vein) every three weeks for an initial 6-week period, then transition to standard care.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome is measured at 21 +/- 4 weeks, indicating follow-up during this period.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05672524

A Study of Tucatinib and Trastuzumab in People With Rectal Cancer

Recruiting
PHASE2Ages 18+InterventionalTreatment
Memorial Sloan Kettering Cancer Center
~37 participants
Updated 2026-05-12 on ClinicalTrials.gov
What's tested:TrastuzumabTucatinib

At a glance

Recruiting sites
7 of 7 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Clinical complete response of study participants
Measured over 21 +/- 4 weeks

Conditions

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

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NCT05672524

Where you'd take part

This study runs at 7 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)

    Basking Ridge, New Jerseystudy coordinator listed

    Recruiting

  • Memorial Sloan Kettering Bergen (Limited Protocol Activities)

    Montvale, New Jerseystudy coordinator listed

    Recruiting

  • Memorial Sloan Kettering Cancer Center (All Protocol Activities)

    New York, New Yorkstudy coordinator listed

    Recruiting

  • Memorial Sloan Kettering Cancer Center at Suffolk - Commack (Limited Protocol Activities)

    Commack, New Yorkstudy coordinator listed

    Recruiting

  • Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

    Middletown, New Jerseystudy coordinator listed

    Recruiting

  • Memorial Sloan Kettering Nassau (Limited Protocol Activities)

    Uniondale, New Yorkstudy coordinator listed

    Recruiting

  • Memorial Sloan Kettering Westchester (Limited Protocol Activities)

    Harrison, New Yorkstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Andrea Cercek, MD · PRINCIPAL_INVESTIGATOR · Memorial Sloan Kettering Cancer

Who to contact

Andrea Cercek, MD
[email protected]
646-888-4189
Email the study team

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Eligibility criteria

Inclusion

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:
Tumor specimen that demonstrates intact mismatch repair enzymes by immunohistochemistry or microsatellite stability as demonstrated by NGS or PCR.
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)
Left ventricular ejection fraction \>=50 assessed by echocardiography
Negative pregnancy test done within 14 days prior to beginning treatment, for women of childbearing potential only. Subjects of childbearing potential must be willing to use an adequate method of contraception. Appropriate methods of birth control include abstinence, oral contraceptives, implantable hormonal contraceptives, or double barrier method (diaphragm plus condom). Contraception is required for the course of the study starting with the first dose of study medication through 150 days after the last dose of study medication. Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject.
≥45 years of age and has not had menses for \>1 year
Patients who have been amenorrhoeic for \<2 years without history of a hysterectomy and oophorectomy must have a follicle stimulating hormone value in the postmenopausal range upon screening evaluation
Post-hysterectomy, post-bilateral oophorectomy, or post-tubal ligation. Documented hysterectomy or oophorectomy must be confirmed with medical records of the actual procedure or confirmed by an ultrasound. Tubal ligation must be confirmed with medical records of the actual procedure, otherwise the patient must be willing to use 2 adequate barrier methods throughout the study.
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.
Absolute neutrophil count (ANC): ≥1,500 /mm3
Platelets: ≥100,000 / mcL
Hemoglobin: \>9 g/dL or ≥5.6 mmol/L
Serum creatinine OR Measured or calculated creatinine clearance (Creatinine clearance should be calculated per institutional standard.) (GFR can also be used in place of creatinine or CrCl): ≤1.5 × upper limit of normal (ULN) OR ≥60 mL/min for subject with creatinine levels \> 1.5 × institutional ULN
Serum total bilirubin: Total bilirubin ≤ 1.5 × upper limit of normal (ULN), except for subjects with known Gilbert's disease who may enroll if the conjugated bilirubin is ≥1.5 x ULN
AST (SGOT) and ALT (SGPT): ≤ 2.5 × ULN
International Normalized Ratio (INR) or Prothrombin Time (PT) Activated Partial Thromboplastin Time (aPTT): For patients not taking warfarin: INR \<1.5 or PT \<1.5 x ULN; and either PTT or aPTT \<1.5 x ULN. Patients on warfarin may be included on a stable dose with a therapeutic INR \<3.5

Exclusion

Recurrent rectal cancer.
Prior pelvic radiation therapy, chemotherapy, or surgery for rectal cancer.
Tumor is causing symptomatic bowel obstruction (patients who have a temporary diverting ostomy are eligible).
Other invasive malignancy ≤ 5 years prior to registration. Exceptions are non-melanoma skin cancer that has undergone potentially curative therapy and in situ cervical carcinoma.
Active infection requiring systemic therapy.
Other Anticancer or Experimental Therapy. No other experimental therapies (including chemotherapy, radiation, hormonal treatment, antibody therapy, immunotherapy, gene therapy, vaccine therapy, angiogenesis inhibitors, matrix metalloprotease inhibitors, thalidomide, anti-VEGF/Flk-1 monoclonal antibody or other experimental drugs) of any kind are permitted while the patient is receiving study treatment.
Known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies)
Known active Hepatitis B (e.g., HbsAg reactive) or Hepatitis C (e.g., HCV RNA \[qualitative\] is detected).
Any known chronic (non-transient) liver disease in the patient's past medical history such as (but not limited to) cirrhosis, NASH (non-alcoholic steatohepatitis) or NAFLD.
Women who are pregnant or breastfeeding, or men expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening visit through 150 days after the last dose of study medication.
Concurrent medical or psychiatric condition or disease which, in the investigator's judgement, would make them inappropriate candidates for entry into the study. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 90 days) myocardial infarction, chronic obstructive pulmonary disease, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, or any psychiatric disorder that prohibits obtaining informed consent.
Received a live vaccine within 30 days of planned start of study medication.
Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to enrollment.
Inability to swallow pills or any significant gastrointestinal disease which would preclude the adequate oral absorption of medications

What this trial measures

  • Clinical complete response of study participants21 +/- 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