SAR445877 for Advanced Cancer
Recruiting in Palo Alto (17 mi)
+21 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1 & 2
Recruiting
Sponsor: Sanofi
Must not be taking: Corticosteroids, Immunosuppressants
Disqualifiers: Brain metastases, Cardiac disease, others
No Placebo Group
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.
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
+3 more
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.
+9 more
Trial 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
Participant Groups
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.
10Treatment groups
Experimental Treatment
Group I: SAR445877 Expansion/Optimization Phase: Cohort E3 (Part 2B)Experimental Treatment2 Interventions
SAR445877 will be administered IV in combination with cetuximab in patients with colorectal cancer (CRC).
Group II: SAR445877 Expansion/Optimization Phase: Cohort E2 (Part 2A)Experimental Treatment1 Intervention
SAR445877 monotherapy will be administered IV in patients with colorectal cancer (CRC).
Group III: SAR445877 Expansion/Optimization Phase: Cohort E1 (Part 2A)Experimental Treatment1 Intervention
SAR445877 monotherapy will be administered IV in patients with colorectal cancer (CRC).
Group IV: SAR445877 Expansion/Optimization Phase: Cohort D (Part 2A)Experimental Treatment1 Intervention
SAR445877 monotherapy will be administered IV in patients with immune infiltrated tumor type.
Group V: SAR445877 Expansion/Optimization Phase: Cohort C2 (Part 2A)Experimental Treatment1 Intervention
SAR445877 monotherapy will be administered IV in patients with gastric cancer/gastro esophageal junction adenocarcinoma (GC/GEJ).
Group VI: SAR445877 Expansion/Optimization Phase: Cohort C1 (Part 2A)Experimental Treatment1 Intervention
SAR445877 monotherapy will be administered IV in patients with gastric cancer/gastro esophageal junction adenocarcinoma (GC/GEJ).
Group VII: SAR445877 Expansion/Optimization Phase: Cohort B (Part 2A)Experimental Treatment1 Intervention
SAR445877 monotherapy will be administered IV in patients with hepatocellular carcinoma (HCC).
Group VIII: SAR445877 Expansion/Optimization Phase: Cohort A2 (Part 2A)Experimental Treatment1 Intervention
SAR445877 monotherapy will be administered intravenously in patients with non-small cell lung cancer (NSCLC).
Group IX: SAR445877 Expansion/Optimization Phase: Cohort A1 (Part 2A)Experimental Treatment1 Intervention
SAR445877 monotherapy will be administered intravenously (IV) in patients with non-small cell lung cancer (NSCLC).
Group X: SAR445877 Escalation Phase (Part 1)Experimental Treatment1 Intervention
SAR445877 monotherapy will be administered intravenously in patients with solid tumors over a 14-day cycle.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of Texas MD Anderson Cancer Center-Site Number:8400005Houston, TX
Rhode Island Hospital-Site Number:8400004Providence, RI
University of Texas MD Anderson Cancer Center-Site Number: 8400005Houston, TX
University of Texas MD Anderson Cancer Center Site Number : 8400005Houston, TX
More Trial Locations
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Who Is Running the Clinical Trial?
SanofiLead Sponsor