Study of SAR444881 Administered Alone and in Combination With Other Therapeutics in Participants With Advanced Solid Tumors

August 4, 2025 updated by: Sanofi

A Phase 1/2, Dose Escalation, Dose Expansion, and Dose Optimization Study of the Safety, Tolerability, and Anti-tumor Activity of SAR444881 Administered Alone and in Combination With Pembrolizumab, Cetuximab and/or Chemotherapy in Participants With Advanced Solid Tumors

The study will enroll advanced cancer patients with unresectable or metastatic disease who are refractory to or are not candidates for standard approved therapy. The study will be comprised of two parts - a dose escalation phase (Part 1) and a dose optimization/expansion phase (Part 2). Part 1 is comprised of three sub-parts: SAR444881 administered alone (Sub-Part 1A), SAR444881 administered in combination with pembrolizumab (Sub-Part 1B), and SAR444881 administered in combination with cetuximab (Sub-Part 1C). Part 2 is composed of two sub-parts: a dose optimization part where up to two doses of SAR444881 per indication are administered in combination with pembrolizumab, cetuximab, and/or carboplatin and pemetrexed (Sub-Part 2A); and a dose expansion part where SAR444881 is administered alone (Sub-Part 2B). In Sub-Part 2A, a two-stage design will be implemented to conduct dose optimization for each indication with combination therapy- Stage 1 (Preliminary Assessment) and Stage 2 (Randomization). Study is non-randomized except Stage 2 of Sub-Part 2A which will use randomization.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Estimated Study Duration:

Dose Escalation (Part 1): Approximately 34 months Dose Optimization/Expansion (Part 2): Approximately 28 months

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
125

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Trial Transparency email recommended (Toll free for US & Canada)
  • Phone Number: option 6 800-633-1610
  • Email: contact-us@sanofi.com

Study Locations

  • Canada
    • Ontario
      • Barrie, Ontario, Canada, L4M 6M2
        • Investigational Site Number : 1240001
    • Quebec
      • Sherbrooke, Quebec, Canada, J1H 5N4
        • Investigational Site Number : 1240003
  • Israel
      • Haifa, Israel, 3109601
        • Investigational Site Number : 3760004
      • Jerusalem, Israel, 9112001
        • Investigational Site Number : 3760005
      • Petah Tikva, Israel, 4941492
        • Investigational Site Number : 3760001
      • Ramat Gan, Israel, 5262100
        • Investigational Site Number : 3760003
      • Tel Aviv, Israel, 6423906
        • Investigational Site Number : 3760002
  • United Kingdom
      • Leeds, United Kingdom, LS9 7TF
        • Investigational Site Number : 8260002
    • London, City Of
      • London, London, City Of, United Kingdom, W12 0HS
        • Investigational Site Number : 8260003
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85054-4504
        • Mayo Clinic Hospital- Site Number : 8400003
    • California
      • Duarte, California, United States, 91030
        • City of Hope Comprehensive Cancer Center- Site Number : 8400002
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado- Site Number : 8400012
    • Connecticut
      • New Haven, Connecticut, United States, 06511
        • Smilow Cancer Center at Yale-New Haven- Site Number : 8400001
    • Florida
      • Clermont, Florida, United States, 34711
        • Clermont Oncology Center- Site Number : 8400005
      • Orange City, Florida, United States, 32763
        • Mid Florida Hematology and Oncology Center- Site Number : 8400006
    • Iowa
      • Des Moines, Iowa, United States, 50314
        • Mercy Cancer Center - MercyOne Richard Deming Cancer Center- Site Number : 8400011
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Norton Cancer Institute - Downtown Women's Cancer Center- Site Number : 8400004
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic Hospital Rochester- Site Number : 8400007

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Patients with unresectable or metastatic disease who are refractory to or are not candidates for standard approved therapy
  • Histologic confirmation of malignancy
  • Measurable disease per RECIST v1.1
  • Eastern Cooperative Oncology Group Performance Status (ECOG) of 0 or 1
  • Participants must have adequate organ function as defined by laboratory tests
  • Part 1: Following tumor types: Breast cancer, cervical cancer, colorectal cancer, adenocarcinoma or squamous cell carcinoma of the esophagus, gastric or gastroesophageal junction adenocarcinoma, squamous cell carcinoma of the head and neck, hepatobiliary cancers (hepatocellular carcinoma (HCC), gallbladder cancer, cholangiocarcinoma), non-small cell lung cancer, renal cell carcinoma, squamous cell carcinoma of the skin, pancreatic adenocarcinoma, ovarian cancer or urothelial carcinoma
  • Part 2: Following tumor types: Squamous cell carcinoma of the head and neck, Gastric or gastroesophageal junction adenocarcinoma, non-squamous non-small cell lung cancer, non-small cell lung cancer, colorectal carcinoma (CRC) any RAS, and/or Cholangiocarcinoma

Exclusion Criteria:

  • Active, known or suspected autoimmune disease
  • Condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications
  • Brain or leptomeningeal metastases
  • Known history of positive test for HIV
  • Non-HCC patients: acute or chronic hepatitis B virus (HBV) or hepatitis C virus (HCV); HCC patients: untreated active HBV or dual infection with HBV/HCV
  • Participants after solid organ or allogeneic hematopoietic stem cell transplant
  • History of life-threatening toxicity related to prior immune therapy
  • History of life-threatening toxicity related to prior cetuximab or other anti-EGFR antibodies (for Sub-Part 1C)
  • Unstable or deteriorating cardiovascular disease within the previous 6 months
  • Any major surgery within 4 weeks of study drug administration
  • Prior/Concomitant Therapy:
  • Cytotoxic/Non-cytotoxic anti-cancer agents, unless at least 4 weeks have elapsed from last dose
  • Use of other investigational drugs within 28 days
  • Prior treatment with macrophage or natural killer (NK) cells activating therapies
  • Administration of a live attenuated vaccine within 28 days

The above information is not intended to contain all considerations relevant to the potential participation in a clinical trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: SAR444881 Dose Escalation (Sub-Part 1A)
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).
Drug: SAR444881
Pharmaceutical form: Solution for infusion; Route of administration: Intravenous
Other Names:
  • BND-22
Experimental: SAR444881 in Combination with Pembrolizumab Dose Escalation (Sub-Part 1B)
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).
Drug: SAR444881
Pharmaceutical form: Solution for infusion; Route of administration: Intravenous
Other Names:
  • BND-22
Drug: Pembrolizumab
Pharmaceutical form: Solution for infusion; Route of administration: Intravenous
Experimental: SAR444881 in Combination with Cetuximab Dose Escalation (Sub-Part 1C)
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).
Drug: SAR444881
Pharmaceutical form: Solution for infusion; Route of administration: Intravenous
Other Names:
  • BND-22
Drug: Cetuximab
Pharmaceutical form: Solution for infusion; Route of administration: Intravenous
Experimental: SAR444881 Dose Optimization (Sub-Part 2A)
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.
Drug: SAR444881
Pharmaceutical form: Solution for infusion; Route of administration: Intravenous
Other Names:
  • BND-22
Drug: Pembrolizumab
Pharmaceutical form: Solution for infusion; Route of administration: Intravenous
Drug: Cetuximab
Pharmaceutical form: Solution for infusion; Route of administration: Intravenous
Drug: Carboplatin
Pharmaceutical form: Concentrate for solution for infusion; Route of administration: Intravenous
Drug: Pemetrexed
Pharmaceutical form: Powder for concentrate for solution for infusion or concentrate for solution for infusion; Route of administration: Intravenous
Experimental: SAR444881 Dose Expansion (Sub-Part 2B)
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.
Drug: SAR444881
Pharmaceutical form: Solution for infusion; Route of administration: Intravenous
Other Names:
  • BND-22

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Part 1: Incidence of treatment-emergent adverse events (TEAEs) dose limiting toxicities (DLT)
Time Frame: Cycle 1 (28 days)
Incidence of TEAEs meeting protocol defined DLT criteria
Cycle 1 (28 days)
Part 2: Objective Response Rate (ORR) per RECIST v1.1
Time Frame: Through study completion, an average of 3 months
Proportion of participants with a best overall response of complete response (CR) or partial response (PR) per RECIST v1.1
Through study completion, an average of 3 months
Part 1: Incidence of treatment-emergent adverse events and serious adverse events
Time Frame: Through study completion, an average of 5 months
Through study completion, an average of 5 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Part 1: Maximum observed plasma concentration [Cmax]
Time Frame: Through study completion, an average of 2 months
Through study completion, an average of 2 months
Part 1: Terminal elimination half-life [T1/2]
Time Frame: Through study completion, an average of 2 months
Through study completion, an average of 2 months
Part 1: Area under the plasma concentration-time curve [AUC]
Time Frame: Through study completion, an average of 2 months
Through study completion, an average of 2 months
Part 1: Incidence of anti-drug antibodies (ADA)
Time Frame: Through study completion, an average of 5 months
Through study completion, an average of 5 months
Part 1: Objective Response Rate (ORR) per RECIST v1.1
Time Frame: Through study completion, an average of 3 months
Proportion of participants with a best overall response of complete response (CR) or partial response (PR) per RECIST v1.1
Through study completion, an average of 3 months
Part 1: Serum concentration at the end of the dosing interval (Ctrough)
Time Frame: Through study completion, an average of 2 months
Through study completion, an average of 2 months
Part 1: time of maximum observed serum concentration (Tmax)
Time Frame: Through study completion, an average of 2 months
Through study completion, an average of 2 months
Part 2: Duration of Response
Time Frame: Through study completion, an average of 6 months
Duration between first documentation of CR or PR to first documentation of disease progression or death due to any cause, whichever occurs first
Through study completion, an average of 6 months
Part 2: Incidence of treatment-emergent adverse events and Serious Adverse Events
Time Frame: Through study completion, an average of 6 months
Through study completion, an average of 6 months
Part 2: Cmax
Time Frame: Through study completion, an average of 3 months
Through study completion, an average of 3 months
Part 2: Ctrough
Time Frame: Through study completion, an average of 3 months
Through study completion, an average of 3 months
Part 2: Tmax
Time Frame: Through study completion, an average of 3 months
Through study completion, an average of 3 months
Part 2: T1/2
Time Frame: Through study completion, an average of 3 months
Through study completion, an average of 3 months
Part 2: AUC
Time Frame: Through study completion, an average of 3 months
Through study completion, an average of 3 months
Part 2: Incidence of ADA
Time Frame: Through study completion, an average of 6 months
Through study completion, an average of 6 months
Part 2: Progression Free Survival (PFS)
Time Frame: Up to 24 months
Time from the date of first dose of study drug to the date of first documented disease progression or death due to any cause, whichever occurs first.
Up to 24 months
PFS rate
Time Frame: At 3, 6, 9, and 12 months, and up to 24 months
Percentage of participants with PFS, per RECIST v1.1
At 3, 6, 9, and 12 months, and up to 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sanofi

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Clinical Sciences & Operations, Sanofi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 11, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 2, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 2, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 15, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 15, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 22, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 7, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 4, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TCD17465
  • BND-22-001 (Other Identifier: Biond)
  • U1111-1277-4421 (Other Identifier: WHO)
  • 2023-504937-30-00 (Registry Identifier: CTIS)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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