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

Part of paid clinical trials in Fairway, Kansas.

Sponsor
Sanofi
Study ID
NCT03192345
Phase
PHASE1
Status
Completed

Conditions

  • Malignant Solid Tumor

Eligibility Criteria

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

Interventions

  • SAR439459 — BIOLOGICAL
    Pharmaceutical form: powder for solution for infusion Route of administration: intravenous infusion
  • Cemiplimab REGN2810 — DRUG
    Pharmaceutical form: solution for infusion Route of administration: intravenous infusion

Study Details

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.

Key Dates

Start date
Jun 9, 2017
Status verified
Aug 2024
Primary completion
Dec 21, 2021
Completion
Jan 17, 2022

Study Design

Enrollment
161 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose Escalation SAR439459 monotherapy
    SAR439459 administered intravenously every 2 weeks in a 14-day cycle with escalating doses
  • Experimental: Dose Expansion SAR439459 monotherapy
    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
  • Experimental: Dose Escalation SAR439459 + cemiplimab combination
    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
  • Experimental: Dose Expansion SAR439459 + cemiplimab combination
    SAR439459 + cemiplimab combination administered intravenously every 3 weeks in a 21-day cycle with previously determined SAR439459 doses and cemiplimab

Primary Outcome Measure

Incidence of Dose Limiting Toxicities (DLTs) [ Time Frame: Through the end of 1 or 2 cycles, total duration up to 6 weeks (for Part 1A each cycle is 2 weeks; for Part 1B each cycle is 2 or 3 weeks) ]

Locations (6)

FacilityCityStateZIPSite coordinators
The University of Kansas Clinical Research Center Site Number : 8400004FairwayKansas66205-
Dana Farber Cancer Institute Site Number : 8400101BostonMassachusetts02115-
Massachusetts General Hospital Site Number : 8400001BostonMassachusetts02114-
Duke University Medical Center Site Number : 8400008DurhamNorth Carolina27710-
Tennessee Oncology, PLLC Site Number : 8400006NashvilleTennessee37203-
Mary Crowley Cancer Research Center Site Number : 8400003DallasTexas75230-

Find similar trials in Fairway, KS

By research site
The University of Kansas Clinical Research Center· Fairway, KSDana Farber Cancer Institute· Boston, MAMassachusetts General Hospital· Boston, MADuke University Medical Center· Durham, NCTennessee Oncology, PLLC· Nashville, TNMary Crowley Cancer Research Center· Dallas, TX

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