What side effects are associated with this type of intervention?

Common treatments for colorectal cancer include chemotherapy regimens such as FOLFOX (oxaliplatin, leucovorin, and fluorouracil) and targeted therapies like trastuzumab and tucatinib for HER2-positive cases. Trastuzumab, which targets HER2 receptors, can cause side effects such as infusion reactions, cardiotoxicity, and gastrointestinal symptoms. Tucatinib, a HER2 tyrosine kinase inhibitor, may lead to diarrhea, hepatotoxicity, and hand-foot syndrome. Chemotherapy agents like oxaliplatin can cause peripheral neuropathy, while fluorouracil may result in mucositis, myelosuppression, and gastrointestinal disturbances.

What prior FDA approvals exist?

FDA-approved treatments for colorectal cancer have primarily focused on chemotherapy, targeted therapy, and immunotherapy. While trastuzumab and tucatinib specifically target HER2 receptors and inhibit HER2 tyrosine kinase, respectively, these types of treatments are more commonly associated with breast cancer. For colorectal cancer, targeted therapies such as cetuximab and panitumumab, which target the EGFR receptor, and regorafenib, a multi-kinase inhibitor, have been approved. There is ongoing research into the efficacy of HER2-targeted therapies like trastuzumab and tucatinib in colorectal cancer, particularly for tumors that overexpress HER2.

What other types of research exist?

Promising novel alternatives to Trastuzumab and Tucatinib for colorectal cancer patients include: 1) Cetuximab and Panitumumab, which target the epidermal growth factor receptor (EGFR) and have shown efficacy in KRAS wild-type metastatic colorectal cancer. 2) Bevacizumab, an anti-VEGF antibody, which has been used in combination with chemotherapy. 3) Larotrectinib and Entrectinib, which target NTRK gene fusions and have shown efficacy in NTRK fusion-positive cancers. 4) Dabrafenib and Trametinib, which target BRAF V600E mutations and have shown efficacy in BRAF-mutated colorectal cancer.

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Monoclonal Antibodies

Tucatinib + Trastuzumab for Rectal Cancer

Phase 2

Recruiting

Led By Andrea Cercek, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 21 +/- 4 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new treatment for people with rectal cancer. It uses two drugs, trastuzumab and tucatinib, along with standard chemotherapy. These drugs aim to block proteins that help cancer grow, while chemotherapy kills the cancer cells.

Who is the study for?

Adults with HER2-positive rectal adenocarcinoma, without distant metastases and measurable disease. Participants must be over 18, have an ECOG performance status of 0 or 1 (fully active or restricted in physically strenuous activity but ambulatory), and adequate organ function. Women of childbearing potential must test negative for pregnancy and agree to use contraception.

What is being tested?

The trial is testing the effectiveness of combining tucatinib and trastuzumab with standard chemotherapy (CAPOX) in treating rectal cancer. Researchers hope this combination will benefit participants by targeting specific aspects of cancer cells.

What are the potential side effects?

Potential side effects may include diarrhea, liver enzyme elevation, fatigue, mouth sores from chemotherapy, heart issues related to trastuzumab, hand-foot syndrome from capecitabine, nerve damage from oxaliplatin, and possible interactions affecting drug metabolism.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 21 +/- 4 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~21 +/- 4 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 21 +/- 4 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Clinical complete response of study participants

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Participant with Rectal AdenocarcinomaExperimental Treatment2 Interventions

Participants will have HER2-positive locally advanced rectal adenocarcinoma.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Trastuzumab

2014

Completed Phase 4

~5190

Tucatinib

2017

Completed Phase 2

~800

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for colorectal cancer include targeted therapies like Trastuzumab and Tucatinib, which focus on the HER2 receptor. Trastuzumab is a monoclonal antibody that binds to the HER2 receptor, inhibiting cell proliferation. Tucatinib is a tyrosine kinase inhibitor that blocks the kinase activity of the HER2 receptor, preventing downstream signaling that promotes tumor growth. These targeted therapies are significant for colorectal cancer patients with HER2 overexpression as they provide a more precise treatment approach, potentially improving clinical outcomes by directly inhibiting tumor growth and proliferation.

Tucatinib, Trastuzumab, and Capecitabine for HER2-Positive Metastatic Breast Cancer.Durable clinical benefit to trastuzumab and chemotherapy in a patient with metastatic colon adenocarcinoma harboring ERBB2 amplification.