Clinical Trials List
Protocol NumberTCD16210
NCT Number(ClinicalTrials.gov Identfier)NCT04418661
Completed
2020-07-01 - 2022-05-01
Phase I/II
Recruiting2
A Phase 1, Open-label, Multicenter, Safety Study of SAR442720 in Combination With Pembrolizumab in Patients With Advanced Malignancies
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Trial Applicant
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Sponsor
Sanofi
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Trial scale
Multi-Regional Multi-Center
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Update
2026/02/01
Investigators and Locations
Co-Principal Investigator
- Shang-Hung Chen Division of Hematology & Oncology
- Po-Wen Lin Division of Colorectal Surgery
- Wu-Chou Su Division of Hematology & Oncology
- Shang-Yin Wu Division of Hematology & Oncology
- Peng-Chan Lin Division of Hematology & Oncology
- Jui-Hung Tsai Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 廖斌志 Division of Hematology & Oncology
- 廖唯昱 Division of Hematology & Oncology
- 吳尚俊 Division of Hematology & Oncology
- YEN-TING LIN Division of Hematology & Oncology
- James Chih-Hsin Yang Division of Hematology & Oncology
- Chong-Jen Yu Division of Hematology & Oncology
- 蔡子修 Division of Hematology & Oncology
- 梁逸歆 Division of Hematology & Oncology
- Hsin-Yu Liu Division of Ophthalmology
- Jih-Hsiang Lee Division of Hematology & Oncology
- JIN-YUAN SHIH Division of Hematology & Oncology
- 許嘉林 Division of Hematology & Oncology
- 郭弘揚 Division of Hematology & Oncology
- 徐偉勛 Division of Hematology & Oncology
- CHAO-CHI HO CHAO-CHI HO Division of Hematology & Oncology
- 楊景堯 Division of Hematology & Oncology
- TSUNG-HAO LIU Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Advanced Malignancies
Objectives
Primary Objective:
To characterize the safety and tolerability of SAR442720 in combination with pembrolizumab in patients with advanced solid tumors including NSCLC who progressed on anti-PD-1/PD L1 containing therapy and advanced colorectal cancer (CRC) after progression to all standard of care (SOC) therapy.
To define the MTD and RP2D for the combination of SAR442720 and pembrolizumab in patients with solid tumors
Secondary Objective:
To document the pharmacokinetic (PK) of SAR442720 in combination with pembrolizumab and to document the PK of pembrolizumab in combination with SAR442720
To estimate the anti-tumor effects of SAR442720 in combination with pembrolizumab in all participants
Test Drug
SAR442720
Active Ingredient
SAR442720
Dosage Form
capsule
Dosage
20/100
Endpoints
Primary Outcome Measures :
Incidence of study-drug related Dose Limiting Toxicities (DLTs) [ Time Frame: 21 days ]
Incidence and nature of DLTs assessed as the occurrence of adverse events (AE) graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.
Incidence of Adverse Events [ Time Frame: up to 2 years ]
Incidence, nature, and severity of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) graded according to the NCI CTCAE v5 for the combination of SAR442720 and pembrolizumab.
Secondary Outcome Measures :
PK of SAR442720 [ Time Frame: up to 2 years ]
Plasma concentrations of SAR442720.
PK of pembrolizumab [ Time Frame: up to 2 years ]
Serum concentrations of pembrolizumab.
Objective response rate (ORR) [ Time Frame: up to 2 years ]
Percentage of participants with a best response of complete response (CR) or partial response (PR) of SAR442720 and pembrolizumab based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Duration of response (DoR) [ Time Frame: up to 2 years ]
Duration of response per RECIST v1.1 is defined as the interval from the first documentation of CR or PR to the earlier of the first documentation of definitive disease progression or death due to any cause, whichever occurs first.
Incidence of study-drug related Dose Limiting Toxicities (DLTs) [ Time Frame: 21 days ]
Incidence and nature of DLTs assessed as the occurrence of adverse events (AE) graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.
Incidence of Adverse Events [ Time Frame: up to 2 years ]
Incidence, nature, and severity of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) graded according to the NCI CTCAE v5 for the combination of SAR442720 and pembrolizumab.
Secondary Outcome Measures :
PK of SAR442720 [ Time Frame: up to 2 years ]
Plasma concentrations of SAR442720.
PK of pembrolizumab [ Time Frame: up to 2 years ]
Serum concentrations of pembrolizumab.
Objective response rate (ORR) [ Time Frame: up to 2 years ]
Percentage of participants with a best response of complete response (CR) or partial response (PR) of SAR442720 and pembrolizumab based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Duration of response (DoR) [ Time Frame: up to 2 years ]
Duration of response per RECIST v1.1 is defined as the interval from the first documentation of CR or PR to the earlier of the first documentation of definitive disease progression or death due to any cause, whichever occurs first.
Inclution Criteria
Inclusion criteria :
Participants must be ≥ 18 years of age
Histologically proven diagnosis of advanced solid tumors
Participants must have one or more of the following molecular aberrations: KRAS mutations and amplifications, BRAF Class 3 mutations, or NF1 LOF mutations
At least 1 measurable disease per RECIST 1.1 criteria.
Eastern Cooperative Oncology Group (ECOG) performance status 0-1
Woman of childbearing potential must agree to follow contraceptive guidance
Capable of giving signed informed consent
Participants must be ≥ 18 years of age
Histologically proven diagnosis of advanced solid tumors
Participants must have one or more of the following molecular aberrations: KRAS mutations and amplifications, BRAF Class 3 mutations, or NF1 LOF mutations
At least 1 measurable disease per RECIST 1.1 criteria.
Eastern Cooperative Oncology Group (ECOG) performance status 0-1
Woman of childbearing potential must agree to follow contraceptive guidance
Capable of giving signed informed consent
Exclusion Criteria
Exclusion criteria:
Predicted life expectancy <3 months.
Primary central nervous system (CNS) tumors.
Symptomatic or impending cord compression.
History of cerebrovascular stroke or transient ischemic attack within previous 6 months.
Prior solid organ or hematologic transplant.
History or current retinal pigment epithelial detachment (RPED), central serous retinopathy, retinal vascular occlusion (RVO), neovascular macular degeneration
Any clinically significant cardiac disease
Active, known or suspected autoimmune disease
History of or current interstitial lung disease or pneumonitis
Receipt of a live-virus vaccination within 28 days of planned treatment start
Known infection with human immunodeficiency virus (HIV), known uncontrolled hepatitis B infection, active tuberculosis, or severe infection requiring parenteral antibiotic treatment.
Inadequate hematologic, hepatic and renal function
Known second malignancy
Impairment of gastrointestinal function
Any unstable or clinically significant concurrent medical condition that would, in the opinion of the investigator, jeopardize the safety of a participant, impact their expected survival through the end of the study participation, and/or impact their ability to comply with the protocol.
History of severe allergic reaction to any of the study intervention components
Predicted life expectancy <3 months.
Primary central nervous system (CNS) tumors.
Symptomatic or impending cord compression.
History of cerebrovascular stroke or transient ischemic attack within previous 6 months.
Prior solid organ or hematologic transplant.
History or current retinal pigment epithelial detachment (RPED), central serous retinopathy, retinal vascular occlusion (RVO), neovascular macular degeneration
Any clinically significant cardiac disease
Active, known or suspected autoimmune disease
History of or current interstitial lung disease or pneumonitis
Receipt of a live-virus vaccination within 28 days of planned treatment start
Known infection with human immunodeficiency virus (HIV), known uncontrolled hepatitis B infection, active tuberculosis, or severe infection requiring parenteral antibiotic treatment.
Inadequate hematologic, hepatic and renal function
Known second malignancy
Impairment of gastrointestinal function
Any unstable or clinically significant concurrent medical condition that would, in the opinion of the investigator, jeopardize the safety of a participant, impact their expected survival through the end of the study participation, and/or impact their ability to comply with the protocol.
History of severe allergic reaction to any of the study intervention components
The Estimated Number of Participants
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Taiwan
10 participants
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Global
24 participants
