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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
Study Summary
This trial will study a new drug to see if it is safe & effective to treat advanced cancers. Up to 240 people will take part.
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.Check my eligibility
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.See study design
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Therapeutic procedure
Dose escalation: Presence of dose-limiting toxicities (DLTs) in Cycles 1 and 2
Dose expansion: Objective response rate (ORR)
Secondary outcome measures
Clinical benefit rate including confirmed CR or PR at any time or stable disease (SD) of at least 6 months determined by Investigator per RECIST 1.1
Dose escalation & expansion Assessment of SAR445877 AUC0-T
Dose escalation & expansion Assessment of SAR445877 Cmax
+6 moreTrial Design
5Treatment groups
Experimental Treatment
Group I: SAR445877 Expansion Phase: Cohort D (Part 2)Experimental Treatment1 Intervention
Participants will receive SAR445877 monotherapy will be administered IV in patients with immune infiltrated tumor type.
Group II: SAR445877 Expansion Phase: Cohort C (Part 2)Experimental Treatment1 Intervention
Participants will receive SAR445877 monotherapy will be administered IV in patients with gastric cancer/gastro esophageal junction adenocarcinoma (GC/GEJ).
Group III: SAR445877 Expansion Phase: Cohort B (Part 2)Experimental Treatment1 Intervention
SAR445877 monotherapy will be administered intravenously in patients with hepatocellular carcinoma (HCC).
Group IV: SAR445877 Expansion Phase: Cohort A (Part 2)Experimental Treatment1 Intervention
SAR445877 monotherapy will be administered intravenously (IV) in patients with non-small cell lung cancer (NSCLC).
Group V: SAR445877 Escalation Phase (Part 1)Experimental Treatment1 Intervention
SAR445877 monotherapy will be administered intravenously in patients with solid tumors over a 14-day cycle.
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Who is running the clinical trial?
SanofiLead Sponsor
2,164 Previous Clinical Trials
3,514,740 Total Patients Enrolled
Clinical Sciences & OperationsStudy DirectorSanofi
862 Previous Clinical Trials
2,019,598 Total Patients Enrolled
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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 Escalation Phase (Part 1)
- Group 2: SAR445877 Expansion Phase: Cohort A (Part 2)
- Group 3: SAR445877 Expansion Phase: Cohort B (Part 2)
- Group 4: SAR445877 Expansion Phase: Cohort C (Part 2)
- Group 5: SAR445877 Expansion Phase: Cohort D (Part 2)
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Might an individual be able to participate in this clinical research endeavor?
"The trial is presently enrolling patients, according to clinicaltrials.gov reports. It was initially launched on the 29th of November 2022 and updated most recently on December 8th 2022."
Answered by AI
What is the aggregate number of participants enrolled in this experiment?
"Confirmed. According to clinicaltrials.gov, this medical trial that first appeared on November 29th 2022 is presently recruiting participants. 240 candidates will be accepted from a single location for this investigation."
Answered by AI
What objectives are researchers hoping to accomplish with this research initiative?
"The primary outcome of this investigation, which will be surveyed from the start to two years after dose expansion, is to assess any presence of dose-limiting toxicities (DLTs) in Cycles 1 and 2. Secondary metrics that shall be assessed include incidences of anti-drug antibodies (ADAs), SAR445877 area under the concentration versus time curve calculated during a dosing interval (T), as well as adverse events graded according to National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 or American Society for Transplantation and Cellular Therapy consensus grading."
Answered by AI
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