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SAR442720 + Other Agents for Advanced Cancer

Phase 1 & 2

Waitlist Available

Research Sponsored by Sanofi

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

Study Summary

This trial is testing the safety and effectiveness of a new drug, SAR442720, when used in combination with either pembrolizumab or adagrasib to treat advanced solid tumors.

Who is the study for?

Adults over 18 with advanced solid tumors and specific genetic mutations (KRAS, BRAF Class 3, NF1 LOF) can join this trial. They must have measurable disease, be in good physical condition (ECOG 0-1), and agree to use birth control. Exclusions include certain eye diseases, lung conditions, recent live vaccines, HIV/hepatitis B/tuberculosis infections, poor organ function or severe medical issues that could affect safety or compliance.Check my eligibility

What is being tested?

The study is testing SAR442720's safety and effectiveness when combined with pembrolizumab for various cancers and with adagrasib specifically for KRAS G12C NSCLC. It aims to find the maximum tolerated dose and recommended phase two dose while also examining how food affects SAR442720's absorption into the body.See study design

What are the potential side effects?

Potential side effects may include reactions related to immune system activation such as inflammation of organs due to pembrolizumab or adagrasib. Other risks might involve vision problems like retinal detachment which are reasons for exclusion from the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer is confirmed to be advanced and not just in one place.

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My cancer has specific genetic changes (KRAS, BRAF, or NF1).

Select...

I am 18 years old or older.

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My cancer has the KRAS G12C mutation.

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I am fully active or can carry out light work.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of Adverse Events (AEs) SAR442720 and adagrasib

Incidence of Adverse Events (AEs) SAR442720 and pembrolizumab

Incidence of study-drug related Dose Limiting Toxicities (DLTs)

+2 more

Secondary outcome measures

Clinical Benefit Rate (CBR)

Disease Control Rate (DCR)

Duration of Response (DOR) of SAR442720 and adagrasib

+11 more

Trial Design

6Treatment groups

Experimental Treatment

Group I: SAR444270 + adagrasib: Dose ExpansionExperimental Treatment2 Interventions

Part 3B: Once SAR442720 dose is confirmed in Part 3A SAR442720 and adagrasib will be administered orally on a continuous basis.

Group II: SAR444270 + adagrasib: Dose EscalationExperimental Treatment2 Interventions

Part 3A; SAR442720 and adagrasib will be administered orally on a continuous basis.

Group III: SAR442720 + Pembrolizumab: Non-small cell lung cancer with Tumor proportion score > 50%Experimental Treatment2 Interventions

Part 2: SAR442720 dose will be administered orally in combination with Pembrolizumab which is given by IV infusion once every 3 weeks (Q3W) or once every 6 weeks (Q6W)

Group IV: SAR442720 + Pembrolizumab: Non-small cell lung cancer with Tumor proportion score 1-49%Experimental Treatment2 Interventions

Part 2: SAR442720 dose will be administered orally in combination with Pembrolizumab which is given by IV infusion once every 3 weeks (Q3W) or once every 6 weeks (Q6W)

Group V: SAR442720 + Pembrolizumab continuousExperimental Treatment2 Interventions

Part 4: SAR442720 will be administered orally in combination with Pembrolizumab which is given by IV infusion once every 3 weeks (Q3W) or once every 6 weeks (Q6W)

Group VI: SAR442720 + PembrolizumabExperimental Treatment2 Interventions

Part 1: SAR442720 (also known as RMC-4630) will be administered orally twice a week (BIW) followed by pembrolizumab which is given intravenously (IV) once every 3 weeks (Q3W). The dose of SAR442720 will be escalated or de-escalated depending on the emerging safety data of the combination.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

2017

Completed Phase 2

~2010

Adagrasib

2023

Completed Phase 1

~20

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

SanofiLead Sponsor

2,162 Previous Clinical Trials

3,512,004 Total Patients Enrolled

Revolution Medicines, Inc.Industry Sponsor

10 Previous Clinical Trials

1,997 Total Patients Enrolled

Mirati Therapeutics Inc.Industry Sponsor

69 Previous Clinical Trials

7,920 Total Patients Enrolled

Media Library

Cancer Clinical Trial 2023: Adagrasib Highlights & Side Effects. Trial Name: NCT04418661 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are new participants accepted for this clinical experiment at the present time?

"Affirmative. According to the information located on clinicaltrials.gov, this research study is actively searching for participants. The trial was initially listed on June 9th 2020 and has since been updated as of October 13th 2022; 133 individuals are sought from six different sites."

Answered by AI

What is the cap on participation in this clinical trial?

"Affirmative, according to the data found on clinicaltrials.gov this research is currently seeking volunteers. The trial was initially made available on June 9th 2020 and has been recently revised on October 13th 2022; it aims to recruit 133 patients from 6 different sites."

Answered by AI

In what ways has SAR442720 been utilized therapeutically?

"SAR442720 is a frequently prescribed drug to treat malignant neoplasms. This medication can also be taken by individuals suffering from unresectable melanoma, microsatellite instability high, or those whose disease progressed after chemotherapy."

Answered by AI

Can you please outline the existing research concerning SAR442720?

"SAR442720 was first researched a decade ago at City of Hope. To date, there are 251 completed clinical trials and 961 ongoing studies; many of which can be found in Orange, California."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Safety and Efficacy Study of SAR442720 in Combination With Other Agents in Advanced Malignancies

2020. "Safety and Efficacy Study of SAR442720 in Combination With Other Agents in Advanced Malignancies". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04418661.