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RecruitingPhase 2NCT05672524

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

Sponsor

Memorial Sloan Kettering Cancer Center

Enrollment

37 participants

Start Date

Dec 30, 2022

Study Type

INTERVENTIONAL

Conditions

Rectal CancerRectal AdenocarcinomaAdenocarcinoma of the RectumLocally Advanced Rectal AdenocarcinomaHER2 Positive Rectal Adenocarcinoma

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether tucatinib (a targeted therapy) combined with trastuzumab (a drug that targets the HER2 protein) can shrink locally advanced rectal cancer tumors in patients whose tumors have a high level of HER2, before surgery. HER2-positive rectal cancers are less common and may respond differently to standard treatments. **You may be eligible if...** - You are 18 or older - You have confirmed HER2-positive rectal adenocarcinoma (a type of rectal cancer) - Your tumor is locally advanced (no distant spread), staged as cT3/cT4 or with lymph node involvement - Your tumor is within 15 cm of the anal opening - You are in good general health (ECOG 0–1) **You may NOT be eligible if...** - Your cancer has already spread to distant organs - Your tumor does not test positive for HER2 - You have a history of severe heart problems or allergic reactions to HER2-targeted drugs - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTrastuzumab

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).

DRUGTucatinib

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).

Locations(7)

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)

Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

Middletown, New Jersey, United States

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Montvale, New Jersey, United States

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

Commack, New York, United States

Memorial Sloan Kettering Westchester (Limited Protocol Activities)

Harrison, New York, United States

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, United States

Memorial Sloan Kettering Nassau (Limited Protocol Activities)

Uniondale, New York, United States

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NCT05672524

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