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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 3, 6, 9, and 12 months, and up to 24 months
Awards & highlights
Study Summary
This trial is testing a new cancer drug, BND-22, which will be given alone or with other approved cancer drugs, pembrolizumab or cetuximab. The study will enroll patients who have advanced cancer that has not responded to standard treatments and who are not candidates for surgery. The study will have two parts: a dose escalation phase, where the drug will be given to 3 patients at 3 different doses to test safety and tolerability, followed by a dose expansion phase.
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.Check my eligibility
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.See study design
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.
Select...
My cancer type is listed among the specified types for this trial.
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Part 1: Incidence of treatment-emergent adverse events (TEAEs) dose limiting toxicities (DLT)
Part 1: Incidence of treatment-emergent adverse events and serious adverse events
Part 2: Objective Response Rate (ORR) per RECIST v1.1
Secondary outcome measures
PFS rate
Part 1: Area under the plasma concentration-time curve [AUC]
Part 1: Incidence of anti-drug antibodies (ADA)
+14 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
Pemetrexed
2014
Completed Phase 3
~5250
Carboplatin
2014
Completed Phase 3
~6670
Pembrolizumab
2017
Completed Phase 2
~2010
Cetuximab
2011
Completed Phase 3
~2480
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
2,164 Previous Clinical Trials
3,514,524 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any other similar drugs to BND-22 that have undergone clinical trials?
"BND-22 was first studied at Mamie McFaddin Ward Cancer Center in 2005. As of now, 616 studies have been completed while 1123 are still active. A large number of these trials are taking place in Phoenix, Arizona."
Answered by AI
Has this type of clinical trial been done before?
"BND-22 has been under medical scrutiny since 2005, when the first trial was completed. The original study into BND-22's effects had 154 participants and was sponsored by Bristol-Myers Squibb. After this initial research project, Phase 2 of clinical trials began. As of now, there are 1123 ongoing studies in 65 different countries across 3235 cities."
Answered by AI
How many individuals are participating in this clinical trial?
"Yes, the study is presently looking for volunteers. The trial was first posted on 4/11/2021 and updated on 4/12/2022. They are admitting 130 patients from 6 locations."
Answered by AI
What medical conditions does BND-22 help alleviate?
"BND-22 is most commonly used to treat melanoma that cannot be removed through surgery. Additionally, this medication can be prescribed to patients who have a high risk of cancer recurrence or microsatellite instability, as well as those who are intolerant to irinotecan."
Answered by AI
Is it possible to still sign up for this experiment?
"That is correct, the information available on clinicaltrials.gov reveals that this trial is ongoing and recruiting patients. This study was first posted on April 11th, 2021 and was updated as recently as today, April 12th, 2022. There are 6 different centres enrolling a total of 130 patients."
Answered by AI
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