A First-in-human Study of the Safety, Pharmacokinetics, Pharmacodynamics and Anti-tumor Activity of SAR439459 Monotherapy and Combination of SAR439459 and Cemiplimab in Patients With Advanced Solid Tumors

Recruiting in Palo Alto (17 mi)

+115 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Sanofi

No Placebo Group

Trial Summary

What is the purpose of this trial?

Primary Objectives: Dose escalation (Part 1) Part 1A (SAR439459 monotherapy) * To determine the maximum tolerated dose (MTD) and/or maximum administered dose (MAD) of SAR439459 when administered intravenously as monotherapy in adult patients with advanced solid tumors. Part 1B (SAR439459 and cemiplimab combination therapy) * To determine the MTD and/or MAD of SAR439459 administered intravenously in combination with cemiplimab administered intravenously in adult patients with advanced solid tumors. Dose expansion (Part 2) Part 2A (SAR439459 monotherapy) * To determine optimal dose of SAR439459 administered intravenously in adult patients with advanced melanoma who have failed a prior therapy based on anti-PD-1 (programmed cell death-1) or anti-PD-L1. Part 2B (SAR439459 and cemiplimab combination therapy) * To determine the objective response rate (ORR) of SAR439459 in combination with cemiplimab in adult patients with selected advanced solid tumors by evaluation of antitumor response according to Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1). Secondary Objectives: * Pharmacokinetic (PK) profile SAR439459 monotherapy and combined with cemiplimab, PK profile of cemiplimab combined with SAR439459. * Immunogenicity of SAR439459 monotherapy and combined with cemiplimab. Dose escalation (Part 1) * Overall safety/tolerability profile of SAR439459 monotherapy and combined with cemiplimab. * Preliminary recommended phase 2 dose (pRP2D) of SAR439459 as monotherapy or combined with cemiplimab. Dose expansion (Part 2) * Progression free survival (PFS), time to progression (TTP), ORR, and safety of SAR439459 as monotherapy and PFS, TTP, duration of response (DOR), disease control rate (DCR) and safety in combination with cemiplimab. * To confirm the optimal dose of SAR439459 administered in combination with cemiplimab.

Research Team

Clinical Sciences & Operations

Principal Investigator

Sanofi

Eligibility Criteria

Inclusion Criteria

Dose escalation (Part 1A and Part 1B)

Patients with histologically confirmed, advanced unresectable or metastatic solid tumor whom in the opinion of the Investigator does not have a suitable alternative therapy.

Dose expansion (Part 2A)

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Treatment Details

Interventions

Cemiplimab REGN2810 (Monoclonal Antibodies)
SAR439459 (Other)

Participant Groups

4Treatment groups

Experimental Treatment

Group I: Dose Expansion SAR439459 monotherapyExperimental Treatment1 Intervention

SAR439459 administered intravenously every 3 weeks in a 21-day cycle with the previously determined recommended doses as the patients will be randomized to 2 different doses

Group II: Dose Expansion SAR439459 + cemiplimab combinationExperimental Treatment2 Interventions

SAR439459 + cemiplimab combination administered intravenously every 3 weeks in a 21-day cycle with previously determined SAR439459 doses and cemiplimab

Group III: Dose Escalation SAR439459 monotherapyExperimental Treatment1 Intervention

SAR439459 administered intravenously every 2 weeks in a 14-day cycle with escalating doses

Group IV: Dose Escalation SAR439459 + cemiplimab combinationExperimental Treatment2 Interventions

SAR439459 + cemiplimab combination administered intravenously every 2 weeks in a 14-day cycle or every 3 weeks in a 21-day cycle with escalating SAR439459 doses and cemiplimab