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Trastuzumab Rezetecan + Chemotherapy + Bevacizumab for Colorectal Cancer

(HORIZON-CRC221 Trial)

BC
SV
Overseen ByScott Varga
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Jiangsu HengRui Medicine Co., Ltd.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This global study is being conducted to evaluate the safety and determine the recommended phase 3 dose of trastuzumab rezetecan in combination with mFOLFOX6 chemotherapy (dose level -1) and bevacizumab as first-line treatment in participants with advanced colorectal cancer that expresses HER2, including but not limited to HER2 immunohistochemistry (IHC) 2+ "equivocal" or 3+ "positive" based on gastric cancer criteria, focused on the Western population. Encouraging data in efficacy and safety with trastuzumab rezetecan in a similar setting in China (NCT06015048) were presented at 2026 American Society of Clinical Oncology annual meeting.

Are You a Good Fit for This Trial?

This trial is for adults with advanced colorectal cancer whose tumors have high levels of HER2. Participants must not have received prior treatment for their advanced disease and should be healthy enough to undergo chemotherapy.

Inclusion Criteria

I am fully active or restricted in physically strenuous activity only.
I have not had prior cancer treatment, or my cancer returned over 6 months after finishing therapy.
I have at least one tumor that can be measured and hasn't been treated locally unless it grew again.
See 1 more

Exclusion Criteria

I finished palliative radiotherapy within the last 2 weeks.
I have not taken any experimental drugs in the past 4 weeks.
I have not had any cancer treatment in the last 4 weeks.
See 8 more

What Are the Treatments Tested in This Trial?

Interventions

  • Trastuzumab Rezetecan (SHR-A1811)

Trial Overview

The study tests two different doses of trastuzumab rezetecan, given with standard mFOLFOX6 chemotherapy and bevacizumab, as the first treatment for HER2-positive advanced colorectal cancer. The goal is to find the safest and most effective dose.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Treatment group BExperimental Treatment1 Intervention
Group II: Treatment group AExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Jiangsu HengRui Medicine Co., Ltd.

Lead Sponsor

Trials
663
Recruited
102,000+
Founded
1970
Headquarters
Lianyungang, China
Known For
Oncology Innovations
Top Products
Camrelizumab, Rivoceranib (Apatinib)

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