A Global Trial of Trastuzumab Rezetecan (SHR-A1811) in Combination With Chemotherapy and Bevacizumab as First-Line Treatment in Patients With Advanced Colorectal Cancer Expressing HER2

Part of paid clinical trials in Houston, Texas.

Sponsor
Jiangsu HengRui Medicine Co., Ltd.
Study ID
NCT07796763
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Advanced Colorectal Cancer Expressing HER2

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Trastuzumab Rezetecan (SHR-A1811) injection; high dose — DRUG
    Trastuzumab Rezetecan (SHR-A1811) injection; high dose
  • Trastuzumab Rezetecan (SHR-A1811) injection; low dose — DRUG
    Trastuzumab Rezetecan (SHR-A1811) injection; low dose

Study Details

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.

Key Dates

First listed
Sep 1, 2026
Start date
Nov 1, 2026
Status verified
Aug 2026
Primary completion
May 1, 2028
Completion
Nov 1, 2028

Study Design

Enrollment
48 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment group A
    Trastuzumab Rezetecan (SHR-A1811; high dose) in Combination with mFOLFOX6 (-1) and Bevacizumab injection
  • Experimental: Treatment group B
    Trastuzumab Rezetecan (SHR-A1811; low dose) in Combination with mFOLFOX6 (-1) and Bevacizumab injection.

Primary Outcome Measure

Incidence of treatment-emergent adverse events [ Time Frame: about two years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
MD Anderson Cancer CenterHoustonTexas77030
Kanwal Raghav, MD (PRINCIPAL_INVESTIGATOR)

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By research site
MD Anderson Cancer Center· Houston, TX