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| ID | Type | Description | Link |
|---|---|---|---|
| BND-22-001 | Other Identifier | Biond | |
| U1111-1277-4421 | Other Identifier | WHO | |
| 2023-504937-30-00 | Registry Identifier | CTIS |
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Early discontinuation based on strategic sponsor decision not driven by any safety concerns
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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.
Estimated Study Duration:
Dose Escalation (Part 1): Approximately 34 months Dose Optimization/Expansion (Part 2): Approximately 28 months
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| 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). |
|
| 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). |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SAR444881 | Drug | Pharmaceutical form: Solution for infusion; Route of administration: Intravenous |
|
| Measure | Description | Time Frame |
|---|---|---|
| Part 1: Incidence of treatment-emergent adverse events (TEAEs) dose limiting toxicities (DLT) | Incidence of TEAEs meeting protocol defined DLT criteria | Cycle 1 (28 days) |
| Part 1: Incidence of treatment-emergent adverse events and serious adverse events | Through study completion, an average of 5 months | |
| Part 2: Objective Response Rate (ORR) per RECIST v1.1 | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Part 1: Objective Response Rate (ORR) per RECIST v1.1 | 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: Maximum observed plasma concentration [Cmax] |
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Inclusion Criteria:
Exclusion Criteria:
The above information is not intended to contain all considerations relevant to the potential participation in a clinical trial.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Sciences & Operations | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic Hospital- Site Number : 8400003 | Phoenix | Arizona | 85054-4504 | United States | ||
| City of Hope Comprehensive Cancer Center- Site Number : 8400002 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36096532 | Derived | 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. |
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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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| 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. |
|
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| Pembrolizumab | Drug | Pharmaceutical form: Solution for infusion; Route of administration: Intravenous |
|
| Cetuximab | Drug | Pharmaceutical form: Solution for infusion; Route of administration: Intravenous |
|
| Carboplatin | Drug | Pharmaceutical form: Concentrate for solution for infusion; Route of administration: Intravenous |
|
| Pemetrexed | Drug | Pharmaceutical form: Powder for concentrate for solution for infusion or concentrate for solution for infusion; Route of administration: Intravenous |
|
| Through study completion, an average of 2 months |
| Part 1: Serum concentration at the end of the dosing interval (Ctrough) | Through study completion, an average of 2 months |
| Part 1: time of maximum observed serum concentration (Tmax) | Through study completion, an average of 2 months |
| Part 1: Terminal elimination half-life [T1/2] | Through study completion, an average of 2 months |
| Part 1: Area under the plasma concentration-time curve [AUC] | Through study completion, an average of 2 months |
| Part 1: Incidence of anti-drug antibodies (ADA) | Through study completion, an average of 5 months |
| Part 2: Progression Free Survival (PFS) | 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 | Percentage of participants with PFS, per RECIST v1.1 | At 3, 6, 9, and 12 months, and up to 24 months |
| Part 2: Duration of Response | 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 | Through study completion, an average of 6 months |
| Part 2: Cmax | Through study completion, an average of 3 months |
| Part 2: Ctrough | Through study completion, an average of 3 months |
| Part 2: Tmax | Through study completion, an average of 3 months |
| Part 2: T1/2 | Through study completion, an average of 3 months |
| Part 2: AUC | Through study completion, an average of 3 months |
| Part 2: Incidence of ADA | Through study completion, an average of 6 months |
| Duarte |
| California |
| 91030 |
| United States |
| University of Colorado- Site Number : 8400012 | Aurora | Colorado | 80045 | United States |
| Smilow Cancer Center at Yale-New Haven- Site Number : 8400001 | New Haven | Connecticut | 06511 | United States |
| Clermont Oncology Center- Site Number : 8400005 | Clermont | Florida | 34711 | United States |
| Mid Florida Hematology and Oncology Center- Site Number : 8400006 | Orange City | Florida | 32763 | United States |
| Mercy Cancer Center - MercyOne Richard Deming Cancer Center- Site Number : 8400011 | Des Moines | Iowa | 50314 | United States |
| Norton Cancer Institute - Downtown Women's Cancer Center- Site Number : 8400004 | Louisville | Kentucky | 40202 | United States |
| Mayo Clinic Hospital Rochester- Site Number : 8400007 | Rochester | Minnesota | 55905 | United States |
| Investigational Site Number : 1240001 | Barrie | Ontario | L4M 6M2 | Canada |
| Investigational Site Number : 1240003 | Sherbrooke | Quebec | J1H 5N4 | Canada |
| Investigational Site Number : 3760004 | Haifa | 3109601 | Israel |
| Investigational Site Number : 3760005 | Jerusalem | 9112001 | Israel |
| Investigational Site Number : 3760001 | Petah Tikva | 4941492 | Israel |
| Investigational Site Number : 3760003 | Ramat Gan | 5262100 | Israel |
| Investigational Site Number : 3760002 | Tel Aviv | 6423906 | Israel |
| Investigational Site Number : 8260003 | London | London, City of | W12 0HS | United Kingdom |
| Investigational Site Number : 8260002 | Leeds | LS9 7TF | United Kingdom |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 29, 2026 |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C582435 | pembrolizumab |
| D000068818 | Cetuximab |
| D016190 | Carboplatin |
| D000068437 | Pemetrexed |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D005971 | Glutamates |
| D024342 | Amino Acids, Acidic |
| D000596 | Amino Acids |
| D000600 | Amino Acids, Dicarboxylic |
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