CancerPhase 1/2NCT04717375
Study of SAR444881 Administered Alone and in Combination With Other Therapeutics in Participants With Advanced Solid Tumors
A Phase 1/2 study testing SAR444881, Pembrolizumab and Cetuximab in people with Cancer and Neoplasm, run by Sanofi at 18 sites in 4 countries.
Trial summary
The study enrolled advanced cancer participants with unresectable or metastatic disease who were refractory to or were not candidates for standard approved therapy. The study comprised of two parts - a dose escalation phase (Part 1) and a dose optimization/expansion phase (Part 2). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- What is being tested?
- SAR444881, Pembrolizumab and Cetuximab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 18 sitesin 4 countries
- Study dates
- 11 Apr 2021to 2 Jul 2025
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants with unresectable or metastatic disease who were refractory to or were not candidates for standard approved therapy
- Histologic confirmation of malignancy
- Measurable disease per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)
- Eastern Cooperative Oncology Group Performance Status (ECOG) of 0 or 1
- Participants must be with 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
Who cannot join
- 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 participants: acute or chronic hepatitis B virus (HBV) or hepatitis C virus (HCV); HCC participants: untreated active HBV or dual infection with HBV/HCV
- Participants after solid organ or allogeneic hematopoietic stem cell transplant
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- 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 was not intended to contain all considerations relevant to the potential participation in a clinical trial.
Trial locations and contacts
18 sites in 4 countries.
18 sites in 4 countries
United States9 sites
University of Colorado- Site Number : 8400012
Aurora, Colorado, 80045
Clermont Oncology Center- Site Number : 8400005
Clermont, Florida, 34711
Mercy Cancer Center - MercyOne Richard Deming Cancer Center- Site Number : 8400011
Des Moines, Iowa, 50314
City of Hope Comprehensive Cancer Center- Site Number : 8400002
Duarte, California, 91030
Norton Cancer Institute - Downtown Women's Cancer Center- Site Number : 8400004
Louisville, Kentucky, 40202
Smilow Cancer Center at Yale-New Haven- Site Number : 8400001
New Haven, Connecticut, 06511
Mid Florida Hematology and Oncology Center- Site Number : 8400006
Orange City, Florida, 32763
Mayo Clinic Hospital- Site Number : 8400003
Phoenix, Arizona, 85054-4504
Mayo Clinic Hospital Rochester- Site Number : 8400007
Rochester, Minnesota, 55905
Israel5 sites
Investigational Site Number : 3760004
Haifa, 3109601
Investigational Site Number : 3760005
Jerusalem, 9112001
Investigational Site Number : 3760001
Petah Tikva, 4941492
Investigational Site Number : 3760003
Ramat Gan, 5262100
Investigational Site Number : 3760002
Tel Aviv, 6423906
Canada2 sites
Investigational Site Number : 1240001
Barrie, Ontario, L4M 6M2
Investigational Site Number : 1240003
Sherbrooke, Quebec, J1H 5N4
United Kingdom2 sites
Investigational Site Number : 8260002
Leeds, LS9 7TF
Investigational Site Number : 8260003
London, London, City of, W12 0HS
About this study
Official title: 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 enrolled advanced cancer participants with unresectable or metastatic disease who were refractory to or were not candidates for standard approved therapy. The study comprised of two parts - a dose escalation phase (Part 1) and a dose optimization/expansion phase (Part 2). Part 1 was 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 was composed of two sub-parts: a dose optimization part where up to two doses of SAR444881 per indication were administered in combination with pembrolizumab, cetuximab, and/or carboplatin and pemetrexed (Sub-Part 2A); and a dose expansion part where SAR444881 was administered alone (Sub-Part 2B). In Sub-Part 2A, a two-stage design would be implemented to conduct dose optimization for each indication with combination therapy- Stage 1 (Preliminary Assessment) and Stage 2 (Randomization). Study was non-randomized except Stage 2 of Sub-Part 2A which would use randomization.
Read the detailed description
Estimated Study Duration:
Dose Escalation (Part 1): Approximately 34 months Dose Optimization/Expansion (Part 2): Approximately 28 months
- Being tested
- SAR444881, Pembrolizumab, Cetuximab, Carboplatin, Pemetrexed
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SAR444881Drug
Also called BND-22
Pharmaceutical form: Solution for infusion; Route of administration: Intravenous
PembrolizumabDrug
Pharmaceutical form: Solution for infusion; Route of administration: Intravenous
CetuximabDrug
Pharmaceutical form: Solution for infusion; Route of administration: Intravenous
CarboplatinDrug
Pharmaceutical form: Concentrate for solution for infusion; Route of administration: Intravenous
PemetrexedDrug
Pharmaceutical form: Powder for concentrate for solution for infusion or concentrate for solution for infusion; Route of administration: Intravenous
| Study group | Role | What they receive |
|---|---|---|
| SAR444881 Dose Escalation (Sub-Part 1A) | Experimental | 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). Receives: Drug: SAR444881 |
| SAR444881 in Combination with Pembrolizumab Dose Escalation (Sub-Part 1B) | Experimental | 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). Receives: Drug: SAR444881; Drug: Pembrolizumab |
| SAR444881 in Combination with Cetuximab Dose Escalation (Sub-Part 1C) | Experimental | 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). Receives: Drug: SAR444881; Drug: Cetuximab |
| SAR444881 Dose Optimization (Sub-Part 2A) | Experimental | 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. Receives: Drug: SAR444881; Drug: Pembrolizumab; Drug: Cetuximab; Drug: Carboplatin; Drug: Pemetrexed |
| SAR444881 Dose Expansion (Sub-Part 2B) | Experimental | 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. Receives: Drug: SAR444881 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1: Sub-Parts 1A, 1B and 1C: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
An AE was any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that did not necessarily have a causal relationship with this treatment. An SAE was any untoward medical occurrence, that at any dose: resulted in death, was life-threatening, required inpatient hospitalization/prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or was an important medical event. A TEAE was any AE that developed, worsened, or became serious during the TE period. TE period was defined as the period from the first study treatment administration to the last study treatment administration + 30 days.
Measured: From first dose of study treatment (Day 1) up to 30 days after last dose of study treatment (considering maximum duration of treatment exposure) i.e., up to approximately Part 1-Sub-Part 1A: 51 weeks, Sub-Part 1B: 126.7 weeks, Sub-Part 1C: 99.3 weeks
Part 1: Sub-Parts 1A, 1B and 1C: Number of Participants With Dose Limiting Toxicities (DLTs)
DLT=drug-related AEs using NCI CTCAE v5.0.Hematological:Grade (G)4 neutropenia >=7 days(D),G4 febrile neutropenia,G4 thrombocytopenia,G3 thrombocytopenia with bleeding,G4 anemia;>=G3/higher non-hematological excluding:increase in liver tests resolved in 7D,diarrhea/associated electrolyte abnormalities \& nausea/vomiting controlled by optimal therapy \& prophylaxis if lasting <72hours(hr),G3 hyperglycemia in diabetes mellitus/decreased glucose tolerance controlled,=>G3 hypophosphatemia,hypomagnesemia \& hypocalcemia resolved by treatment in 72 hr,G3 endocrinopathy controlled,G3/G4 elevation of amylase or lipase not associated with pancreatitis,laboratory value out of normal range with no clinical correlate \& resolved with medical management to =<G1 in 7D,G3 rash resolved to <=G1,cetuximab-related dermatologic toxicity,transient (<=24 hr) headache resolved to <=G1,G3 fatigue <7D,G3 tumor flare,G3 fever not associated with hemodynamic compromise,G3 infusion reaction returned to G1 in <6 hr.
Measured: Up to 28 days following the administration of study treatment (Day 1 of Cycle 1, at any dose)
Part 2: Sub-Part 2A: Stage 1 Cohorts C1 and E1 and Sub-Part 2B: Stage 1 Cohort D1: Objective Response Rate (ORR)
ORR was defined as the percentage of participants in the population of interest with a best overall response (BOR) of either complete response (CR) or partial response (PR) per response evaluation criteria in solid tumors (RECIST) version (v)1.1. CR was defined as disappearance of all target lesions; any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 millimeter (mm). PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Measured: From first dose of study treatment administration (Day 1) up to maximum exposure of study treatment, i.e., approximately 36 weeks for Cohort C1, 25 weeks for Cohort E1 and 33 weeks for Cohort D1
Secondary outcomes (22)
Part 1: Sub-Parts 1A, 1B and 1C: Objective Response Rate
ORR was defined as the percentage of participants in the population of interest with a BOR of either CR or PR per RECIST v1.1. CR was defined as disappearance of all target lesions; any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Percentages are rounded off to the tenth decimal place.
Measured: From first dose of study treatment administration (Day 1) up to maximum exposure of study treatment, i.e., approximately 47 weeks for Sub-Part 1A, 122.7 weeks for Sub-Part 1B and 95.3 weeks for Sub-Part 1C
Part 1: Sub-Part 1A: Maximum Observed Serum Concentration (Cmax) of SAR444881
Blood samples were collected at specified timepoints to determine Cmax of SAR44488. Here, end of infusion (EOI) = 1 hour after infusion start for all doses except 0.1 mg/kg; 30 min after infusion start for 0.1 mg/kg dose.
Measured: pre-dose, EOI, 4, 8, 24 hours and 7 days post-dose 1 in Cycle 1 Day 1; pre-dose of dose 2 in Cycle 1 Day 15
Part 1: Sub-Parts 1B and 1C: Maximum Observed Serum Concentration of SAR444881
Blood samples were collected at specified timepoints to determine Cmax of SAR44488. Here, EOI = 1 hour after infusion start.
Measured: Part 1B: pre-dose, EOI, 4, 8, 24 hours and 7 and 14 days post-dose in Cycle 1 Day 1; pre-dose in Cycle 2 Day 1; Part 1C: pre-dose, EOI, 4, 8, 24 hours and 7 days post-dose in Cycle 1 Day 1; pre-dose in Cycle 1 Day 15
Part 2: Sub-Part 2A: Stage 1 Cohorts C1 and E1, Sub-Part 2B: Stage 1 Cohot D1: Maximum Observed Serum Concentration of SAR444881
Blood samples were collected at specified timepoints to determine Cmax of SAR44488. Participants missed few scheduled site visits for sample collection and only participants with data collected at specified timepoints are reported.
Measured: Pre-dose, EOI (1 hour after infusion start), 24 hours and 7 days post dose in Cycle 1 Day 1; pre-dose in Cycle 1 Day 15
Part 1: Sub-Part 1A: Last Concentration Observed Above the Lower Limit of Quantification (Clast) of SAR444881
Blood samples were collected at specified timepoints to determine Clast of SAR44488. Here, EOI = 1 hour after infusion start for all doses except 0.1 mg/kg; 30 min after infusion start for 0.1 mg/kg dose.
Measured: Pre-dose, EOI, 4, 8, 24 hours and 7 days post-dose 1 in Cycle 1 Day 1; pre-dose of dose 2 in Cycle 1 Day 15
Part 1: Sub-Parts 1B and 1C: Last Concentration Observed Above the Lower Limit of Quantification of SAR444881
Blood samples were collected at specified timepoints to determine Clast of SAR44488. Here, EOI = 1 hour after infusion start.
Measured: Part 1B: pre-dose, EOI, 4, 8, 24 hours and 7 and 14 days post-dose in Cycle 1 Day 1; pre-dose in Cycle 2 Day 1; Part 1C: pre-dose, EOI, 4, 8, 24 hours and 7 days post-dose in Cycle 1 Day 1; pre-dose in Cycle 1 Day 15
Part 2: Sub-Part 2A: Stage 1 Cohorts C1 and E1, Sub-Part 2B: Stage 1 Cohot D1: Last Concentration Observed Above the Lower Limit of Quantification of SAR444881
Blood samples were collected at specified timepoints to determine Clast of SAR44488. Participants missed few scheduled site visits for sample collection and only participants with data collected at specified timepoints are reported.
Measured: Pre-dose, EOI (1 hour after infusion start), 24 hours and 7 days post dose in Cycle 1 Day 1; pre-dose in Cycle 1 Day 15
Part 1: Sub-Part 1A: Time to Reach Maximum Observed Concentration (Tmax) of SAR444881
Blood samples were collected at specified timepoints to determine Tmax of SAR44488. Here, EOI = 1 hour after infusion start for all doses except 0.1 mg/kg; 30 min after infusion start for 0.1 mg/kg dose.
Measured: Pre-dose, EOI, 4, 8, 24 hours and 7 days post-dose 1 in Cycle 1 Day 1; pre-dose in Cycle 1 Day 15
Part 1: Sub-Parts 1B and 1C: Time to Reach Maximum Observed Concentration of SAR444881
Blood samples were collected at specified timepoints to determine Tmax of SAR44488. Here, EOI = 1 hour after infusion start.
Measured: Part 1B: pre-dose, EOI, 4, 8, 24 hours and 7 and 14 days post-dose in Cycle 1 Day 1; pre-dose in Cycle 2 Day 1; Part 1C: pre-dose, EOI, 4, 8, 24 hours and 7 days post-dose in Cycle 1 Day 1; pre-dose in Cycle 1 Day 15
Part 2: Sub-Part 2A: Stage 1 Cohorts C1 and E1, Sub-Part 2B: Stage 1: Cohot D1 Time to Reach Maximum Observed Concentration of SAR444881
Blood samples were collected at specified timepoints to determine Tmax of SAR44488. Participants missed few scheduled site visits for sample collection and only participants with data collected at specified timepoints are reported.
Measured: Pre-dose, EOI (1 hour after infusion start), 24 hours and 7 days post dose in Cycle 1 Day 1; pre-dose in Cycle 1 Day 15
Part 1: Sub-Part 1A: Half Life (T1/2) of SAR444881
Blood samples were planned to be collected at specified timepoints to determine T1/2 of SAR44488. Because this immunoglobulin (Ig)G4 monoclonal antibody has a long elimination half-life, the PK sampling window between the 1st and 2nd doses was not long enough to characterize the terminal elimination phase. As a result, the terminal elimination rate constant - and therefore the terminal half-life - could not be estimated by noncompartmental analysis. In other words, the true half-life was equal to or exceeded the duration of the post-first-dose sampling period (dosing interval). This outcome measure is therefore not reported.
Measured: Planned at pre-dose, EOI, 4, 8, 24 hours and 7 days post-dose 1 in Cycle 1 Day 1; pre-dose of dose 2 in Cycle 1 Day 15
Part 1: Sub-Parts 1B and 1C: Half Life of SAR444881
Blood samples were planned to be collected at specified timepoints to determine T1/2 of SAR44488. Because this IgG4 monoclonal antibody has a long elimination half-life, the PK sampling window between the 1st and 2nd doses was not long enough to characterize the terminal elimination phase. As a result, the terminal elimination rate constant - and therefore the terminal half-life - could not be estimated by noncompartmental analysis. In other words, the true half-life was equal to or exceeded the duration of the post-first-dose sampling period (dosing interval). This outcome measure is therefore not reported.
Measured: Planned at: Part 1B: pre-dose, EOI, 4, 8, 24 hours and 7 and 14 days post-dose 1 in Cycle 1 Day 1; pre-dose of dose 2 in Cycle 2 Day 1; Part 1C: pre-dose, EOI, 4, 8, 24 hours and 7 days post-dose 1 in Cycle 1 Day 1; pre-dose of dose 2 in Cycle 1 Day 15
Part 2: Sub-Part 2A: Stage 1 Cohorts C1 and E1, Sub-Part 2B: Stage 1 Cohot D1: Half Life of SAR444881
Blood samples were planned to be collected at specified timepoints to determine T1/2 of SAR44488. Because this IgG4 monoclonal antibody has a long elimination half-life, the PK sampling window between the 1st and 2nd doses was not long enough to characterize the terminal elimination phase. As a result, the terminal elimination rate constant - and therefore the terminal half-life - could not be estimated by noncompartmental analysis. In other words, the true half-life was equal to or exceeded the duration of the post-first-dose sampling period (dosing interval). This outcome measure is therefore not reported.
Measured: Planned at pre-dose, EOI, 24 hours and 7 days post dose 1 in Cycle 1 Day 1; pre-dose of dose 2 in Cycle 1 Day 15
Part 1: Sub-Part 1A: Area Under the Concentration-time Curve (AUC) of SAR444881
Blood samples were planned to be collected at specified timepoints to determine AUC of SAR44488. The long elimination half-life of this IgG4 monoclonal antibody meant that the sampling period between the 1st and 2nd doses was insufficient to capture the terminal elimination phase. Since AUC extrapolation to infinity relies on a reliably estimated terminal elimination rate constant, AUC could not be estimated by noncompartmental analysis. This outcome measure is therefore not reported.
Measured: Planned at pre-dose, EOI, 4, 8, 24 hours and 7 days post-dose 1 in Cycle 1 Day 1; pre-dose of dose 2 in Cycle 1 Day 15
Part 1: Sub-Parts 1B and 1C: Area Under the Concentration-time Curve of SAR444881
Blood samples were planned to be collected at specified timepoints to determine AUC of SAR44488. The long elimination half-life of this IgG4 monoclonal antibody meant that the sampling period between the 1st and 2nd doses was insufficient to capture the terminal elimination phase. Since AUC extrapolation to infinity relies on a reliably estimated terminal elimination rate constant, AUC could not be estimated by noncompartmental analysis. This outcome measure is therefore not reported.
Measured: Planned at: Part 1B: pre-dose, EOI, 4, 8, 24 hours and 7 and 14 days post-dose 1 in Cycle 1 Day 1; pre-dose of dose 2 in Cycle 2 Day 1; Part 1C: pre-dose, EOI, 4, 8, 24 hours and 7 days post-dose 1 in Cycle 1 Day 1; pre-dose of dose 2 in Cycle 1 Day 15
Part 2: Sub-Part 2A: Stage 1 Cohorts C1 and E1, Sub-Part 2B: Stage 1 Cohot D1: Area Under the Concentration-time Curve of SAR444881
Blood samples were planned to be collected at specified timepoints to determine AUC of SAR44488. The long elimination half-life of this IgG4 monoclonal antibody meant that the sampling period between the 1st and 2nd doses was insufficient to capture the terminal elimination phase. Since AUC extrapolation to infinity relies on a reliably estimated terminal elimination rate constant, AUC could not be estimated by noncompartmental analysis. This outcome measure is therefore not reported.
Measured: Planned at pre-dose, EOI, 24 hours and 7 days post dose 1 in Cycle 1 Day 1; pre-dose of dose 2 in Cycle 1 Day 15
Part 1: Sub-Parts 1A, 1B and 1C and Part 2: Sub-Part 2A: Stage 1 Cohorts C1 and E1 and Sub-Part 2B: Stage 2 Cohort D1: Number of Participants With Anti-Drug Antibodies (ADAs) Against SAR444881
Plasma samples were collected to assess the antibodies against SAR444881. Treatment-emergent ADA was defined as a participant with at least 1 treatment-induced/boosted ADA. Non-treatment emergent ADA was defined as participant without any treatment-induced/boosted ADA and without any inconclusive sample nor unclassified ADA during the TE period.
Measured: From first dose of study drug (Day 1) up to maximum exposure of study treatment,i.e.,approximately 47 weeks for Part 1A, 122.7 weeks for Part 1B,95.3 weeks for Part 1C;Sub-Part 2: 36 weeks for Cohort C1, 25 weeks for Cohort E1 and 33 weeks for Cohort D1
Part 2: Sub-Part 2A: Stage 1 Cohorts C1 and E1, Sub-Part 2B: Stage 1 Cohot D1: Progression-Free Survival (PFS)
PFS was defined as the time from the first dosing date to the date of first objectively documented disease progression or death due to any cause, whichever occurred first.
Measured: From first dose of study treatment administration (Day 1) up to maximum exposure of study treatment, i.e., approximately 36 weeks for Cohort C1, 25 weeks for Cohort E1 and 33 weeks for Cohort D1
Part 2: Sub-Part 2A: Stage 1 Cohorts C1 and E1, Sub-Part 2B: Stage 1 Cohot D1: Progression-Free Survival Rate
PFS rate was defined as the percentage of participants in the population of interest with first objectively documented disease progression or death due to any cause, whichever occurred first.
Measured: At 3, 6 ,9 ,12 and 24 months
Part 2: Sub-Part 2A: Stage 1 Cohorts C1 and E1, Sub-Part 2B: Stage 1 Cohot D1: Disease Control Rate (DCR)
DCR was defined as the percentage of participants in the population of interest whose BOR was either confirmed CR or PR, or stable disease (SD). CR was defined as disappearance of all target lesions; any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study.
Measured: From first dose of study treatment administration (Day 1) up to maximum exposure of study treatment, i.e., approximately 36 weeks for Cohort C1, 25 weeks for Cohort E1 and 33 weeks for Cohort D1
Part 2: Sub-Part 2A: Stage 1 Cohorts C1 and E1, Sub-Part 2B: Stage 1 Cohot D1: Duration of Response (DoR)
DoR for a participant with a BOR of confirmed CR or PR was defined as the time between the date of first confirmed response and the date of the first objectively documented tumor progression per RECIST v1.1 or death, whichever occurred first. CR was defined as disappearance of all target lesions; any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Measured: From first dose of study treatment administration (Day 1) up to maximum exposure of study treatment, i.e., approximately 36 weeks for Cohort C1, 25 weeks for Cohort E1 and 33 weeks for Cohort D1
Part 2: Sub-Part 2A: Stage 1 Cohorts C1 and E1, Sub-Part 2B: Stage 1 Cohot D1: Number of Participants With Treatment-emergent Adverse Events and Treatment-emergent Serious Adverse Events
An AE was any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that did not necessarily have a causal relationship with this treatment. An SAE was any untoward medical occurrence, that at any dose: resulted in death, was life-threatening, required inpatient hospitalization/prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or was an important medical event. A TEAE was any AE that developed, worsened, or became serious during the TE period. TE period was defined as the period from the first study treatment administration to the last study treatment administration + 30 days.
Measured: From first dose of study treatment (Day 1) up to 30 days after last dose of study treatment (considering maximum duration of treatment exposure) i.e., up to approximately Part 2-Stage 1-Cohort C1: 40 weeks, Cohort E1: 29 weeks and Cohort D1: 37 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2021
- Study start11 Apr 2021
- Primary completion2 Jul 2025
- Study completion2 Jul 2025
Why it stopped: Early discontinuation based on strategic sponsor decision not driven by any safety concerns
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04717375
- Sponsor's protocol ID
- TCD17465
- Other IDs
- BND-22-001, U1111-1277-4421, 2023-504937-30-00, 2023
- Status last verified
- Sep 2026
- First submitted
- 15 Jan 2021
- Last updated
- 29 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Publications
Mandel I, Haves Ziv D, Goldshtein I, Peretz T, Alishekevitz D, Fridman Dror A, Hakim M, Hashmueli S, Friedman I, Sapir Y, Greco R, Qu H, Nestle F, Wiederschain D, Pao L, Sharma S, Ben Moshe T. BND-22, a first-in-class humanized ILT2-blocking antibody, promotes antitumor immunity and tumor regression. J Immunother Cancer. 2022 Sep;10(9):e004859. doi: 10.1136/jitc-2022-004859.
PubMed 36096532
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04717375
- Acronym / sponsor ID
- TCD17465
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Early discontinuation based on strategic sponsor decision not driven by any safety concerns
- Enrolment
- 125 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- 11 Apr 2021 (actual)
- Primary completion
- 2 Jul 2025 (actual)
- Study completion
- 2 Jul 2025 (actual)
- First posted
- 22 Jan 2021 (actual)
- Results
- Posted 29 Sep 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study enrolled advanced cancer participants with unresectable or metastatic disease who were refractory to or were not candidates for standard approved therapy. The study comprised of two parts - a dose escalation phase (Part 1) and a dose optimization/expansion phase (Part 2). Part 1 was 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 was composed of two sub-parts: a dose optimization part where up to two doses of SAR444881 per indication were administered in combination with pembrolizumab, cetuximab, and/or carboplatin and pemetrexed (Sub-Part 2A); and a dose expansion part where SAR444881 was administered alone (Sub-Part 2B). In Sub-Part 2A, a two-stage design would be implemented to conduct dose optimization for each indication with combination therapy- Stage 1 (Preliminary Assessment) and Stage 2 (Randomization). Study was non-randomized except Stage 2 of Sub-Part 2A which would use randomization.
Detailed description
Estimated Study Duration:
Dose Escalation (Part 1): Approximately 34 months Dose Optimization/Expansion (Part 2): Approximately 28 months
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| SAR444881 Dose Escalation (Sub-Part 1A) | Experimental | Drug: SAR444881Standard "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). |
| SAR444881 in Combination with Pembrolizumab Dose Escalation (Sub-Part 1B) | Experimental | Drug: SAR444881, Drug: PembrolizumabStandard "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). |
| SAR444881 in Combination with Cetuximab Dose Escalation (Sub-Part 1C) | Experimental | Drug: SAR444881, Drug: CetuximabStandard "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). |
| SAR444881 Dose Optimization (Sub-Part 2A) | Experimental | Drug: SAR444881, Drug: Pembrolizumab, Drug: Cetuximab, Drug: Carboplatin, Drug: PemetrexedSAR444881 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. |
| SAR444881 Dose Expansion (Sub-Part 2B) | Experimental | Drug: SAR444881The indication for this monotherapy cohort is cholangiocarcinoma. Enrollment will be opened based on emerging data from the dose-escalation phase and combination optimization data. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Participants with unresectable or metastatic disease who were refractory to or were not candidates for standard approved therapy
- Histologic confirmation of malignancy
- Measurable disease per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)
- Eastern Cooperative Oncology Group Performance Status (ECOG) of 0 or 1
- Participants must be with adequate organ function as defined by laboratory tests
Key exclusion criteria (16 listed)
- 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 participants: acute or chronic hepatitis B virus (HBV) or hepatitis C virus (HCV); HCC participants: untreated active HBV or dual infection with HBV/HCV
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SAR444881Also: BND-22Pharmaceutical form: Solution for infusion; Route of administration: Intravenous | Drug | SAR444881 Dose Escalation (Sub-Part 1A), SAR444881 Dose Expansion (Sub-Part 2B), SAR444881 Dose Optimization (Sub-Part 2A), SAR444881 in Combination with Cetuximab Dose Escalation (Sub-Part 1C), SAR444881 in Combination with Pembrolizumab Dose Escalation (Sub-Part 1B) |
| PembrolizumabPharmaceutical form: Solution for infusion; Route of administration: Intravenous | Drug | SAR444881 Dose Optimization (Sub-Part 2A), SAR444881 in Combination with Pembrolizumab Dose Escalation (Sub-Part 1B) |
| CetuximabPharmaceutical form: Solution for infusion; Route of administration: Intravenous | Drug | SAR444881 Dose Optimization (Sub-Part 2A), SAR444881 in Combination with Cetuximab Dose Escalation (Sub-Part 1C) |
| CarboplatinPharmaceutical form: Concentrate for solution for infusion; Route of administration: Intravenous | Drug | SAR444881 Dose Optimization (Sub-Part 2A) |
| PemetrexedPharmaceutical form: Powder for concentrate for solution for infusion or concentrate for solution for infusion; Route of administration: Intravenous | Drug | SAR444881 Dose Optimization (Sub-Part 2A) |
Primary outcome
Part 1: Sub-Parts 1A, 1B and 1C: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
Time frame: From first dose of study treatment (Day 1) up to 30 days after last dose of study treatment (considering maximum duration of treatment exposure) i.e., up to approximately Part 1-Sub-Part 1A: 51 weeks, Sub-Part 1B: 126.7 weeks, Sub-Part 1C: 99.3 weeks
An AE was any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that did not necessarily have a causal relationship with this treatment. An SAE was any untoward medical occurrence, that at any dose: resulted in death, was life-threatening, required inpatient hospitalization/prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or was an important medical event. A TEAE was any AE that developed, worsened, or became serious during the TE period. TE period was defined as the period from the first study treatment administration to the last study treatment administration + 30 days.
Part 1: Sub-Parts 1A, 1B and 1C: Number of Participants With Dose Limiting Toxicities (DLTs)
Time frame: Up to 28 days following the administration of study treatment (Day 1 of Cycle 1, at any dose)
DLT=drug-related AEs using NCI CTCAE v5.0.Hematological:Grade (G)4 neutropenia >=7 days(D),G4 febrile neutropenia,G4 thrombocytopenia,G3 thrombocytopenia with bleeding,G4 anemia;>=G3/higher non-hematological excluding:increase in liver tests resolved in 7D,diarrhea/associated electrolyte abnormalities \& nausea/vomiting controlled by optimal therapy \& prophylaxis if lasting <72hours(hr),G3 hyperglycemia in diabetes mellitus/decreased glucose tolerance controlled,=>G3 hypophosphatemia,hypomagnesemia \& hypocalcemia resolved by treatment in 72 hr,G3 endocrinopathy controlled,G3/G4 elevation of amylase or lipase not associated with pancreatitis,laboratory value out of normal range with no clinical correlate \& resolved with medical management to =<G1 in 7D,G3 rash resolved to <=G1,cetuximab-related dermatologic toxicity,transient (<=24 hr) headache resolved to <=G1,G3 fatigue <7D,G3 tumor flare,G3 fever not associated with hemodynamic compromise,G3 infusion reaction returned to G1 in <6 hr.
Part 2: Sub-Part 2A: Stage 1 Cohorts C1 and E1 and Sub-Part 2B: Stage 1 Cohort D1: Objective Response Rate (ORR)
Time frame: From first dose of study treatment administration (Day 1) up to maximum exposure of study treatment, i.e., approximately 36 weeks for Cohort C1, 25 weeks for Cohort E1 and 33 weeks for Cohort D1
ORR was defined as the percentage of participants in the population of interest with a best overall response (BOR) of either complete response (CR) or partial response (PR) per response evaluation criteria in solid tumors (RECIST) version (v)1.1. CR was defined as disappearance of all target lesions; any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 millimeter (mm). PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
22 secondary outcomes
Part 1: Sub-Parts 1A, 1B and 1C: Objective Response Rate
Time frame: From first dose of study treatment administration (Day 1) up to maximum exposure of study treatment, i.e., approximately 47 weeks for Sub-Part 1A, 122.7 weeks for Sub-Part 1B and 95.3 weeks for Sub-Part 1C
Part 1: Sub-Part 1A: Maximum Observed Serum Concentration (Cmax) of SAR444881
Time frame: pre-dose, EOI, 4, 8, 24 hours and 7 days post-dose 1 in Cycle 1 Day 1; pre-dose of dose 2 in Cycle 1 Day 15
Part 1: Sub-Parts 1B and 1C: Maximum Observed Serum Concentration of SAR444881
Time frame: Part 1B: pre-dose, EOI, 4, 8, 24 hours and 7 and 14 days post-dose in Cycle 1 Day 1; pre-dose in Cycle 2 Day 1; Part 1C: pre-dose, EOI, 4, 8, 24 hours and 7 days post-dose in Cycle 1 Day 1; pre-dose in Cycle 1 Day 15
Part 2: Sub-Part 2A: Stage 1 Cohorts C1 and E1, Sub-Part 2B: Stage 1 Cohot D1: Maximum Observed Serum Concentration of SAR444881
Time frame: Pre-dose, EOI (1 hour after infusion start), 24 hours and 7 days post dose in Cycle 1 Day 1; pre-dose in Cycle 1 Day 15
Part 1: Sub-Part 1A: Last Concentration Observed Above the Lower Limit of Quantification (Clast) of SAR444881
Time frame: Pre-dose, EOI, 4, 8, 24 hours and 7 days post-dose 1 in Cycle 1 Day 1; pre-dose of dose 2 in Cycle 1 Day 15
Part 1: Sub-Parts 1B and 1C: Last Concentration Observed Above the Lower Limit of Quantification of SAR444881
Time frame: Part 1B: pre-dose, EOI, 4, 8, 24 hours and 7 and 14 days post-dose in Cycle 1 Day 1; pre-dose in Cycle 2 Day 1; Part 1C: pre-dose, EOI, 4, 8, 24 hours and 7 days post-dose in Cycle 1 Day 1; pre-dose in Cycle 1 Day 15
Part 2: Sub-Part 2A: Stage 1 Cohorts C1 and E1, Sub-Part 2B: Stage 1 Cohot D1: Last Concentration Observed Above the Lower Limit of Quantification of SAR444881
Time frame: Pre-dose, EOI (1 hour after infusion start), 24 hours and 7 days post dose in Cycle 1 Day 1; pre-dose in Cycle 1 Day 15
Part 1: Sub-Part 1A: Time to Reach Maximum Observed Concentration (Tmax) of SAR444881
Time frame: Pre-dose, EOI, 4, 8, 24 hours and 7 days post-dose 1 in Cycle 1 Day 1; pre-dose in Cycle 1 Day 15
Part 1: Sub-Parts 1B and 1C: Time to Reach Maximum Observed Concentration of SAR444881
Time frame: Part 1B: pre-dose, EOI, 4, 8, 24 hours and 7 and 14 days post-dose in Cycle 1 Day 1; pre-dose in Cycle 2 Day 1; Part 1C: pre-dose, EOI, 4, 8, 24 hours and 7 days post-dose in Cycle 1 Day 1; pre-dose in Cycle 1 Day 15
Part 2: Sub-Part 2A: Stage 1 Cohorts C1 and E1, Sub-Part 2B: Stage 1: Cohot D1 Time to Reach Maximum Observed Concentration of SAR444881
Time frame: Pre-dose, EOI (1 hour after infusion start), 24 hours and 7 days post dose in Cycle 1 Day 1; pre-dose in Cycle 1 Day 15
Part 1: Sub-Part 1A: Half Life (T1/2) of SAR444881
Time frame: Planned at pre-dose, EOI, 4, 8, 24 hours and 7 days post-dose 1 in Cycle 1 Day 1; pre-dose of dose 2 in Cycle 1 Day 15
Part 1: Sub-Parts 1B and 1C: Half Life of SAR444881
Time frame: Planned at: Part 1B: pre-dose, EOI, 4, 8, 24 hours and 7 and 14 days post-dose 1 in Cycle 1 Day 1; pre-dose of dose 2 in Cycle 2 Day 1; Part 1C: pre-dose, EOI, 4, 8, 24 hours and 7 days post-dose 1 in Cycle 1 Day 1; pre-dose of dose 2 in Cycle 1 Day 15
Part 2: Sub-Part 2A: Stage 1 Cohorts C1 and E1, Sub-Part 2B: Stage 1 Cohot D1: Half Life of SAR444881
Time frame: Planned at pre-dose, EOI, 24 hours and 7 days post dose 1 in Cycle 1 Day 1; pre-dose of dose 2 in Cycle 1 Day 15
Part 1: Sub-Part 1A: Area Under the Concentration-time Curve (AUC) of SAR444881
Time frame: Planned at pre-dose, EOI, 4, 8, 24 hours and 7 days post-dose 1 in Cycle 1 Day 1; pre-dose of dose 2 in Cycle 1 Day 15
Part 1: Sub-Parts 1B and 1C: Area Under the Concentration-time Curve of SAR444881
Time frame: Planned at: Part 1B: pre-dose, EOI, 4, 8, 24 hours and 7 and 14 days post-dose 1 in Cycle 1 Day 1; pre-dose of dose 2 in Cycle 2 Day 1; Part 1C: pre-dose, EOI, 4, 8, 24 hours and 7 days post-dose 1 in Cycle 1 Day 1; pre-dose of dose 2 in Cycle 1 Day 15
Part 2: Sub-Part 2A: Stage 1 Cohorts C1 and E1, Sub-Part 2B: Stage 1 Cohot D1: Area Under the Concentration-time Curve of SAR444881
Time frame: Planned at pre-dose, EOI, 24 hours and 7 days post dose 1 in Cycle 1 Day 1; pre-dose of dose 2 in Cycle 1 Day 15
Part 1: Sub-Parts 1A, 1B and 1C and Part 2: Sub-Part 2A: Stage 1 Cohorts C1 and E1 and Sub-Part 2B: Stage 2 Cohort D1: Number of Participants With Anti-Drug Antibodies (ADAs) Against SAR444881
Time frame: From first dose of study drug (Day 1) up to maximum exposure of study treatment,i.e.,approximately 47 weeks for Part 1A, 122.7 weeks for Part 1B,95.3 weeks for Part 1C;Sub-Part 2: 36 weeks for Cohort C1, 25 weeks for Cohort E1 and 33 weeks for Cohort D1
Part 2: Sub-Part 2A: Stage 1 Cohorts C1 and E1, Sub-Part 2B: Stage 1 Cohot D1: Progression-Free Survival (PFS)
Time frame: From first dose of study treatment administration (Day 1) up to maximum exposure of study treatment, i.e., approximately 36 weeks for Cohort C1, 25 weeks for Cohort E1 and 33 weeks for Cohort D1
Part 2: Sub-Part 2A: Stage 1 Cohorts C1 and E1, Sub-Part 2B: Stage 1 Cohot D1: Progression-Free Survival Rate
Time frame: At 3, 6 ,9 ,12 and 24 months
Part 2: Sub-Part 2A: Stage 1 Cohorts C1 and E1, Sub-Part 2B: Stage 1 Cohot D1: Disease Control Rate (DCR)
Time frame: From first dose of study treatment administration (Day 1) up to maximum exposure of study treatment, i.e., approximately 36 weeks for Cohort C1, 25 weeks for Cohort E1 and 33 weeks for Cohort D1
Part 2: Sub-Part 2A: Stage 1 Cohorts C1 and E1, Sub-Part 2B: Stage 1 Cohot D1: Duration of Response (DoR)
Time frame: From first dose of study treatment administration (Day 1) up to maximum exposure of study treatment, i.e., approximately 36 weeks for Cohort C1, 25 weeks for Cohort E1 and 33 weeks for Cohort D1
Part 2: Sub-Part 2A: Stage 1 Cohorts C1 and E1, Sub-Part 2B: Stage 1 Cohot D1: Number of Participants With Treatment-emergent Adverse Events and Treatment-emergent Serious Adverse Events
Time frame: From first dose of study treatment (Day 1) up to 30 days after last dose of study treatment (considering maximum duration of treatment exposure) i.e., up to approximately Part 2-Stage 1-Cohort C1: 40 weeks, Cohort E1: 29 weeks and Cohort D1: 37 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36096532Mandel I, Haves Ziv D, Goldshtein I, Peretz T, Alishekevitz D, Fridman Dror A, Hakim M, Hashmueli S, Friedman I, Sapir Y, Greco R, Qu H, Nestle F, Wiederschain D, Pao L, Sharma S, Ben Moshe T. BND-22, a first-in-class humanized ILT2-blocking antibody, promotes antitumor immunity and tumor regression. J Immunother Cancer. 2022 Sep;10(9):e004859. doi: 10.1136/jitc-2022-004859.
- Individual participant dataSharing planned: Yes. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Sciences & Operations study director
Sanofi
18 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing SAR444881, Pembrolizumab and Cetuximab in people with Cancer and Neoplasm, run by Sanofi at 18 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States, Israel, Canada, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Sep 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part 1: Sub-Parts 1A, 1B and 1C: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) (time frame: From first dose of study treatment (Day 1) up to 30 days after last dose of study treatment (considering maximum duration of treatment exposure) i.e., up to approximately Part 1-Sub-Part 1A: 51 weeks, Sub-Part 1B: 126.7 weeks, Sub-Part 1C: 99.3 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04717375, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2026.