Dose Escalation and Expansion Study of SAR444200-based Regimen in Adult Participants With Advanced Solid Tumors

Part of paid clinical trials in Los Angeles, California.

Sponsor
Sanofi
Study ID
NCT05450562
Phase
PHASE1/PHASE2
Status
Terminated

Conditions

  • Neoplasm

Eligibility Criteria

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

Interventions

  • SAR444200 — BIOLOGICAL
    Sterile lyophilized powder for solution for infusion Route of administration: intravenous (IV) infusion
  • Atezolizumab — BIOLOGICAL
    concentrate for solution for infusion Route of administration: intravenous (IV) infusion

Study Details

This is Phase 1/Phase 2, open label, multiple cohort, first-in-human study to evaluate safety, PK, PDy and efficacy of SAR444200 as a monotherapy or in combination with other anti-cancer agents for participants aged at least 18 years with previously treated metastatic malignancies.

Key Dates

Start date
Sep 20, 2022
Status verified
Jan 2026
Primary completion
Dec 22, 2025
Completion
Dec 22, 2025

Study Design

Enrollment
33 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: SAR444200 - Dose Escalation Phase (Part 1A)
    SAR444200 will be administered as intravenous injection as monotherapy in participants with GPC3+ solid tumors over a 21-day cycle
  • Experimental: SAR444200 - Dose Expansion Phase (Part 2A)
    SAR444200 will be administered as intravenous injection in participants with GPC3+ NSCLC over a 21-day cycle
  • Experimental: SAR444200 and Atezolizumab combination therapy - Dose Escalation Phase (Part 1B)
    SAR444200 in combination with atezolizumab will be administered as intravenous injection in participants with GPC3+ solid tumors over a 21-day cycle

Primary Outcome Measure

Part 1A and 1B: Number of participants with Dose Limiting Toxicities (DLTs) [ Time Frame: For Part 1A: from the Cycle 1, Day 1 up to Day 21For Part 1B: from Cycle 2 Day 1 up to Day 21 ]

Locations (4)

FacilityCityStateZIPSite coordinators
USC Norris Comprehensive Cancer Center- Site Number : 8400004Los AngelesCalifornia90033-
Icahn School of Medicine at Mount Sinai- Site Number : 8400005New YorkNew York10029-
Lifespan Corporation- Site Number : 8400002ProvidenceRhode Island02903-
The University of Texas MD Anderson Cancer Center- Site Number : 8400003HoustonTexas77030-

Find similar trials in Los Angeles, CA

By research site
USC Norris Comprehensive Cancer Center· Los Angeles, CAIcahn School of Medicine at Mount Sinai· New York, NYLifespan Corporation· Providence, RIThe University of Texas MD Anderson Cancer Center· Houston, TX

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