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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline to the end of study (up to 2 years)
Awards & highlights
No Placebo-Only Group
Summary
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.
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
As this is an early-phase trial for SAR445877, detailed side effects are not yet fully known but may include typical reactions seen with cancer therapies such as fatigue, nausea, immune-related issues or infusion reactions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from baseline to the end of study (up to 2 years)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline to the end of study (up to 2 years)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Therapeutic procedure
Dose escalation: Presence of dose-limiting toxicities (DLTs) in Cycles 1 and 2
Dose expansion/optimization: Objective response rate (ORR)
Secondary study objectives
Dose escalation & expansion/optimization: Assessment of Cetuximab serum concentration
Dose escalation & expansion/optimization: Assessment of SAR445877 AUC0-T
Dose escalation & expansion/optimization: Assessment of SAR445877 Cmax
+8 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cetuximab
2011
Completed Phase 3
~2480
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for solid tumors include chemotherapy, targeted therapy, and immunotherapy. Chemotherapy works by killing rapidly dividing cells, which includes cancer cells, but also affects normal cells, leading to side effects.
Targeted therapy involves drugs designed to specifically target molecular abnormalities in cancer cells, such as mutations in genes like EGFR or ALK, thereby sparing normal cells and reducing side effects. Immunotherapy, including checkpoint inhibitors like anti-PD-1 or anti-CTLA-4, boosts the body's immune system to recognize and destroy cancer cells.
These treatments are crucial for solid tumor patients as they offer different mechanisms to control or eliminate tumors, potentially improving survival and quality of life.
Current trends and future directions in the genetic therapy of human neoplastic disease.
Current trends and future directions in the genetic therapy of human neoplastic disease.
Find a Location
Who is running the clinical trial?
SanofiLead Sponsor
2,204 Previous Clinical Trials
4,036,493 Total Patients Enrolled
Clinical Sciences & OperationsStudy DirectorSanofi
873 Previous Clinical Trials
2,020,566 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My daily activity is limited due to my health condition.I have advanced cancer with no standard treatment options left.I am on continuous corticosteroid therapy for a health condition.I have advanced liver cancer that cannot be removed by surgery.I have an active autoimmune disease.I have had side effects from immune therapy before.I have active brain or spinal cord tumor spread.I have a history of lung scarring or inflammation not caused by infections.I haven't had any other cancers needing treatment in the last 2 years.My liver function is classified as Child Pugh Class B or C.I do not have an active or uncontrolled infection like HIV, hepatitis B, or C, nor do I have an immunodeficiency.I am able to understand and sign the consent form.I have been diagnosed with metastatic non-small cell lung cancer.I am on immunosuppressive drugs due to an organ transplant.I have a serious heart or blood vessel condition.I have advanced gastric cancer or cancer at the junction of my stomach and esophagus that cannot be surgically removed.
Research Study Groups:
This trial has the following groups:- Group 1: SAR445877 Expansion/Optimization Phase: Cohort A2 (Part 2A)
- Group 2: SAR445877 Expansion/Optimization Phase: Cohort E1 (Part 2A)
- Group 3: SAR445877 Expansion/Optimization Phase: Cohort B (Part 2A)
- Group 4: SAR445877 Expansion/Optimization Phase: Cohort C1 (Part 2A)
- Group 5: SAR445877 Expansion/Optimization Phase: Cohort A1 (Part 2A)
- Group 6: SAR445877 Expansion/Optimization Phase: Cohort C2 (Part 2A)
- Group 7: SAR445877 Expansion/Optimization Phase: Cohort D (Part 2A)
- Group 8: SAR445877 Expansion/Optimization Phase: Cohort E2 (Part 2A)
- Group 9: SAR445877 Expansion/Optimization Phase: Cohort E3 (Part 2B)
- Group 10: SAR445877 Escalation Phase (Part 1)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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