Phase 1 Study Of SAR445877 In Combination With FOLFOX6 And Bevacizumab As First-Line Treatment For Microsatellite Stable Metastatic Colorectal Cancer

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT07500298
Phase
PHASE1
Status
Recruiting
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Conditions

  • Bevacizimab
  • FOlfox6
  • First Line Treatment
  • Metastatic Colorectal Cancer (CRC)
  • Microsatellite Stable
  • Phase 1
  • SAR445877

Eligibility Criteria

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

Interventions

  • SAR445877 — DRUG
    Given by IV
  • FOLFOX6 — DRUG
    Given by IV
  • Bevacizumab — DRUG
    Given by IV

Study Details

To learn if SAR445877 in combination with FOLFOX6 and bevacizumab can be safely given to patients with advanced MSS CRC.

Key Dates

Start date
May 20, 2026
Status verified
May 2026
Primary completion
Dec 27, 2030
Completion
Dec 27, 2032

Study Design

Enrollment
41 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Dose ESC (Part 1)
    In the dose escalation part of the study, three dose levels of SAR445877 will be evaluated using the Bayesian optimal interval (BOIN) design to determine the MTD.
  • Experimental: Dose EXP (Part 2)
    The dose expansion part of the study will further evaluate the MTD, as determined in the dose escalation, and will be conducted using the Bayesian optimal Phase 2 (BOP2) design.

Primary Outcome Measure

Safety and adverse events (AEs) [ Time Frame: Through study completion; an average of 1 year. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
MD Anderson Cancer CenterHoustonTexas77030
Aung Naing, MD
[email protected]
713-563-3885
Aung Naing, MD (PRINCIPAL_INVESTIGATOR)

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By research site
MD Anderson Cancer Center· Houston, TX

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