SAR445877 for Advanced Cancer

Recruiting at 25 trial locations

Overseen By Trial Transparency email recommended (Toll free for US & Canada)

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Sanofi

Must not be taking: Corticosteroids, Immunosuppressants

Disqualifiers: Brain metastases, Cardiac disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

291 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests a new drug, SAR445877, for adults with advanced cancers that are hard to treat. The study will find the best amount to use and check if the drug is safe and works well, both alone and with other treatments.

Do I need to stop my current medications to join the trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you are on ongoing corticosteroid therapy or have certain health conditions, you may not be eligible to participate. It's best to discuss your specific medications with the trial team.

Research Team

Clinical Sciences & Operations

Principal Investigator

Sanofi

Eligibility Criteria

Adults with advanced solid tumors that can't be surgically removed or have spread, and who lack suitable standard treatments. Specific groups include those with certain types of lung, stomach, liver cancers, and gastroesophageal junction adenocarcinoma. Participants must have measurable disease and give informed consent.

Inclusion Criteria

I have advanced cancer with no standard treatment options left.

I have advanced liver cancer that cannot be removed by surgery.

Measurable Disease: At least 1 measurable lesion per RECIST 1.1 criteria

Exclusion Criteria

My daily activity is limited due to my health condition.

Predicted life expectancy ≤3 months

I am on continuous corticosteroid therapy for a health condition.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

Dose Escalation

Finding the therapeutic dose(s) of SAR445877 in monotherapy and in combination with other anticancer therapies

Up to 2 years

Every 2 weeks or weekly

Dose Expansion/Optimization

Assessment of safety and preliminary efficacy of SAR445877 in monotherapy and in combination with cetuximab

Up to 2 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

Until disease progression or start of new anticancer therapy

Treatment Details

Interventions

• SAR445877

Trial Overview SAR445877 is being tested as a solo treatment for various advanced cancers. The trial has two parts: the first to find the best dose given every week or every other week; the second to test safety and early results at two dose levels in specific cancer types.

Participant Groups

Group I: SAR445877 Japan Cohort F Experimental Treatment 1 Intervention

SAR445877 monotherapy will be administered intravenously in participants with advanced unresectable or metastatic solid tumor, from Japan.

Group II: SAR445877 Expansion/Optimization Phase: Cohort E3 (Part 2B) Experimental Treatment 2 Interventions

SAR445877 will be administered IV in combination with cetuximab in participants with colorectal cancer (CRC).

Group III: SAR445877 Expansion/Optimization Phase: Cohort E2 (Part 2A) Experimental Treatment 1 Intervention

SAR445877 monotherapy will be administered IV in participants with colorectal cancer (CRC).

Group IV: SAR445877 Expansion/Optimization Phase: Cohort E1 (Part 2A) Experimental Treatment 1 Intervention

SAR445877 monotherapy will be administered IV in participants with colorectal cancer (CRC).

Group V: SAR445877 Expansion/Optimization Phase: Cohort D (Part 2A) Experimental Treatment 1 Intervention

SAR445877 monotherapy will be administered IV in participants with immune infiltrated tumor type.

Group VI: SAR445877 Expansion/Optimization Phase: Cohort C2 (Part 2A) Experimental Treatment 1 Intervention

SAR445877 monotherapy will be administered IV in participants with gastric cancer/gastro esophageal junction adenocarcinoma (GC/GEJ).

Group VII: SAR445877 Expansion/Optimization Phase: Cohort C1 (Part 2A) Experimental Treatment 1 Intervention

SAR445877 monotherapy will be administered IV in participants with gastric cancer/gastro esophageal junction adenocarcinoma (GC/GEJ).

Group VIII: SAR445877 Expansion/Optimization Phase: Cohort B (Part 2A) Experimental Treatment 1 Intervention

SAR445877 monotherapy will be administered IV in participants with hepatocellular carcinoma (HCC).

Group IX: SAR445877 Expansion/Optimization Phase: Cohort A2 (Part 2A) Experimental Treatment 1 Intervention

SAR445877 monotherapy will be administered intravenously in participants with non-small cell lung cancer (NSCLC).

Group X: SAR445877 Expansion/Optimization Phase: Cohort A1 (Part 2A) Experimental Treatment 1 Intervention

SAR445877 monotherapy will be administered intravenously (IV) in participants with non-small cell lung cancer (NSCLC).

Group XI: SAR445877 Escalation Phase (Part 1) Experimental Treatment 1 Intervention

SAR445877 monotherapy will be administered intravenously in participants with solid tumors over a 14-day cycle.

Who Is Running the Clinical Trial?

Sanofi

Lead Sponsor

Trials

2,246

Recruited

4,085,000+

Paul Hudson

Sanofi

Chief Executive Officer since 2019

Degree in Economics from Manchester Metropolitan University

Christopher Corsico

Sanofi

Chief Medical Officer

MD from Cornell University, MPH in Chronic Disease Epidemiology from Yale University