Safety and Efficacy Study of SAR442720 in Combination With Pembrolizumab in Advanced Malignancies

  • STATUS
    Recruiting
  • End date
    May 8, 2024
  • participants needed
    88
  • sponsor
    Sanofi
Updated on 8 July 2021
cancer
measurable disease
BRAF
KRAS
pembrolizumab
solid neoplasm

Summary

Primary Objective:

Part 1:

  • To characterize the safety and tolerability of SAR442720 in combination with pembrolizumab in patients with advanced solid tumors including NSCLC who progressed on anti-PD-1/PD L1 containing therapy and advanced colorectal cancer (CRC) after progression to all standard of care (SOC) therapy.
  • To define the MTD and RP2D for the combination of SAR442720 and pembrolizumab in patients with solid tumors

Part 2:

  • To determine the antitumor activity of SAR442720 in combination with pembrolizumab

Secondary Objective:

Part 1:

  • To document the pharmacokinetic (PK) of SAR442720 in combination with pembrolizumab and to document the PK of pembrolizumab in combination with SAR442720
  • To estimate the anti-tumor effects of SAR442720 in combination with pembrolizumab in all participants

Part 2:

  • To assess the safety profile of SAR442720 in combination with pembrolizumab
  • To assess other indicators of antitumor activity.
  • To assess the pharmacokinetic (PK) of SAR442720 in combination with pembrolizumab, and to assess the PK of pembrolizumab in combination with SAR442720

Description

This open label Phase 1 multicenter study is designed to evaluate the safety and maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of SAR442720 in combination with pembrolizumab in participants with solid tumors in Part 1.

In Part 2, in the expansion cohort (Cohort A) we will assess the antitumor activity and safety of SAR442720 combined with pembrolizumab in participants with metastatic 1L lung cancer.

The expected duration of study intervention for participants may vary, based on progression date; median expected duration of study per participant is estimated to be about 10 months in Part 1 (up to 1 month for screening, a median of 6 months for treatment, and a median of 3 months for long term follow-up) and in Part 2 16 months (up to 1 month for screening, a median of 12 months for treatment and a median of 3 months for long term follow up.)

Details
Condition Metastasis, Liver Metastases, Bone Metastases, Brain Metastases, Cancer, Metastatic, Metastatic Cancer, Neoplasm Metastasis, metastases, metastatic disease, secondary cancer, secondaries, metastatic tumor, metastasized
Treatment Pembrolizumab, SAR442720
Clinical Study IdentifierNCT04418661
SponsorSanofi
Last Modified on8 July 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Participants must be 18 years of age
Histologically proven diagnosis of advanced solid tumors
Participants must have one or more of the following molecular aberrations (Part 1): KRAS mutations and amplifications, BRAF Class 3 mutations, or NF1 LOF mutations
At least 1 measurable disease per RECIST 1.1 criteria
Eastern Cooperative Oncology Group (ECOG) performance status 0-1
Woman of childbearing potential must agree to follow contraceptive guidance
Capable of giving signed informed consent

Exclusion Criteria

Predicted life expectancy <3 months
Primary central nervous system (CNS) tumors
Symptomatic or impending cord compression
History of cerebrovascular stroke or transient ischemic attack within previous 6 months
Prior solid organ or hematologic transplant
History or current retinal pigment epithelial detachment (RPED), central serous retinopathy, retinal vascular occlusion (RVO), neovascular macular degeneration
Any clinically significant cardiac disease
Active, known or suspected autoimmune disease
History of or current interstitial lung disease or pneumonitis
Receipt of a live-virus vaccination within 28 days of planned treatment start
Known infection with human immunodeficiency virus (HIV), known uncontrolled hepatitis B infection, active tuberculosis, or severe infection requiring parenteral antibiotic treatment
Inadequate hematologic, hepatic and renal function
Known second malignancy
Impairment of gastrointestinal function
Any unstable or clinically significant concurrent medical condition that would, in the opinion of the investigator, jeopardize the safety of a participant, impact their expected survival through the end of the study participation, and/or impact their ability to comply with the protocol
History of severe allergic reaction to any of the study intervention components
The above information is not intended to contain all considerations relevant
to a patient's potential participation in a clinical trial
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