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Monoclonal Antibodies
SAR444881 + Standard Therapies for Advanced Cancer
Phase 1 & 2
Recruiting
Research Sponsored by Biond Biologics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients with unresectable or metastatic disease who are refractory to or are not candidates for standard approved therapy
Eastern Cooperative Oncology Group Performance Status (ECOG) of 0 or 1
Must not have
Condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications
Participants after solid organ or allogeneic hematopoietic stem cell transplant
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 3, 6, 9, and 12 months, and up to 24 months
Awards & highlights
Summary
This trial tests a new drug, SAR444881, alone and with other treatments in advanced cancer patients who haven't responded to other therapies. The goal is to find the best dose and combination to treat these patients effectively.
Who is the study for?
This trial is for adults with advanced solid tumors that can't be removed by surgery or have spread, and who haven't responded to standard treatments. They must be physically able to perform daily activities (ECOG 0-1) and have proper organ function. Specific cancers like lung, breast, head and neck among others are included depending on the study part.
What is being tested?
The trial tests SAR444881 alone and in combinations with pembrolizumab, cetuximab, carboplatin, or pemetrexed. It has two parts: dose escalation to find safe levels of SAR444881 (alone/with drugs), then dose optimization/expansion where effective doses are given more widely. Part of the second phase involves random selection for treatment groups.
What are the potential side effects?
Potential side effects include those common to cancer therapies such as immune reactions due to pembrolizumab or cetuximab; blood count changes from carboplatin/pemetrexed; fatigue; liver function changes; skin reactions; digestive issues like nausea/vomiting.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer cannot be removed by surgery and does not respond to standard treatments.
Select...
I am fully active or can carry out light work.
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My cancer type is listed among the specified types for this trial.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am on steroids or other drugs that suppress my immune system.
Select...
I have had a solid organ or bone marrow transplant.
Select...
I have hepatitis B or C, or both, and if I have liver cancer, it's untreated.
Select...
I have an autoimmune disease.
Select...
I have had a severe reaction to previous immune therapy.
Select...
My cancer has spread to my brain or the lining around my brain.
Select...
I have had severe reactions to cetuximab or similar medications before.
Select...
I have previously received treatments that activate macrophages or NK cells.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 3, 6, 9, and 12 months, and up to 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 3, 6, 9, and 12 months, and up to 24 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Part 1: Incidence of treatment-emergent adverse events (TEAEs) dose limiting toxicities (DLT)
Part 2: Objective Response Rate (ORR) per RECIST v1.1
Secondary study objectives
PFS rate
Part 1: Objective Response Rate (ORR) per RECIST v1.1
Part 2: Duration of Response
+1 moreTrial Design
5Treatment groups
Experimental Treatment
Group I: SAR444881 in Combination with Pembrolizumab Dose Escalation (Sub-Part 1B)Experimental Treatment2 Interventions
Standard "3 + 3" dose escalation design with enrollment of at least 3 participants per dose level cohort. SAR444881 and pembrolizumab will be administered intravenously (IV), every 3 weeks (Q3W).
Group II: SAR444881 in Combination with Cetuximab Dose Escalation (Sub-Part 1C)Experimental Treatment2 Interventions
Standard "3 + 3" dose escalation design with enrollment of at least 3 participants per dose level cohort. SAR444881 and cetuximab will be administered intravenously (IV), every 2 weeks (Q2W).
Group III: SAR444881 Dose Optimization (Sub-Part 2A)Experimental Treatment5 Interventions
SAR444881 Dose Optimization in combination with pembrolizumab/carboplatin/pemetrexed, pembrolizumab, or cetuximab. The indication for the combination cohorts will be non-squamous non-small cell lung cancer (NSCLC), gastric cancer or gastro-esophageal junction adenocarcinoma (GC/GEJ), colorectal carcinoma (CRC) any RAS. Enrollment will start after the recommended dose(s) of SAR444881 have been determined based on data from Sub-Parts 1A, 1B, and 1C.
Group IV: SAR444881 Dose Expansion (Sub-Part 2B)Experimental Treatment1 Intervention
The indication for this monotherapy cohort is cholangiocarcinoma. Enrollment will be opened based on emerging data from the dose-escalation phase and combination optimization data.
Group V: SAR444881 Dose Escalation (Sub-Part 1A)Experimental Treatment1 Intervention
Standard "3 + 3" dose escalation design with enrollment of at least 3 participants per dose level cohort. SAR444881 will be administered intravenously (IV), every 2 weeks (Q2W).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Carboplatin
2014
Completed Phase 3
~6120
Pemetrexed
2014
Completed Phase 3
~5550
Pembrolizumab
2017
Completed Phase 3
~2850
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 cancer treatments include immunotherapy and targeted therapy. Immunotherapy, such as pembrolizumab, works by enhancing the body's immune system to recognize and attack cancer cells.
Targeted therapy, like cetuximab, involves drugs designed to target specific molecules involved in cancer cell growth and survival, such as the epidermal growth factor receptor (EGFR). These treatments are significant for cancer patients because they offer more personalized and potentially more effective options with fewer side effects compared to traditional chemotherapy, improving both survival rates and quality of life.
Current status of molecular-targeted drugs for endometrial cancer (Review).
Current status of molecular-targeted drugs for endometrial cancer (Review).
Find a Location
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Biond BiologicsLead Sponsor
1 Previous Clinical Trials
280 Total Patients Enrolled
SanofiLead Sponsor
2,190 Previous Clinical Trials
4,034,103 Total Patients Enrolled
Natalia Ashtamker, MDStudy DirectorBiond Biologics
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am on steroids or other drugs that suppress my immune system.I have had a solid organ or bone marrow transplant.My cancer is one of the following: head and neck, stomach, or non-small cell lung cancer.My cancer cannot be removed by surgery and does not respond to standard treatments.I have not received a live vaccine in the last 28 days.I have hepatitis B or C, or both, and if I have liver cancer, it's untreated.My organ functions are within normal ranges according to recent lab tests.My heart condition has been stable for the last 6 months.You have taken any experimental drugs in the past 28 days.I have not had major surgery in the last 4 weeks.I have an autoimmune disease.I have had a severe reaction to previous immune therapy.My cancer has spread to my brain or the lining around my brain.I am fully active or can carry out light work.I have had severe reactions to cetuximab or similar medications before.My cancer type is listed among the specified types for this trial.It's been over 4 weeks since my last cancer treatment.I have previously received treatments that activate macrophages or NK cells.
Research Study Groups:
This trial has the following groups:- Group 1: SAR444881 Dose Optimization (Sub-Part 2A)
- Group 2: SAR444881 Dose Expansion (Sub-Part 2B)
- Group 3: SAR444881 Dose Escalation (Sub-Part 1A)
- Group 4: SAR444881 in Combination with Pembrolizumab Dose Escalation (Sub-Part 1B)
- Group 5: SAR444881 in Combination with Cetuximab Dose Escalation (Sub-Part 1C)
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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