Safety Study of SAR442720 in Combination With Pembrolizumab in Patients With Advanced Malignancies
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|ClinicalTrials.gov Identifier: NCT04418661|
Recruitment Status : Recruiting
First Posted : June 5, 2020
Last Update Posted : March 29, 2021
- 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
- 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
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Neoplasm||Drug: SAR442720 Drug: Pembrolizumab||Phase 1|
This open label Phase 1 multicenter study is designed to evaluate the safety and maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of SAR442720 in combination with pembrolizumab in participants with solid tumors.
The expected duration of study intervention for participants may vary, based on progression date; median expected duration of study per participant is estimated to be about 10 months (up to 1 month for screening, a median of 6 months for treatment, and a median of 3 months for long term follow-up).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1, Open-label, Multicenter, Safety Study of SAR442720 in Combination With Pembrolizumab in Patients With Advanced Malignancies|
|Actual Study Start Date :||June 16, 2020|
|Estimated Primary Completion Date :||May 2023|
|Estimated Study Completion Date :||May 2023|
SAR442720 (also known as RMC-4630) will be administered orally with pembrolizumab which is given by IV once every 3 weeks (Q3W). The dose of SAR442720 will be escalated or de-escalated depending on the emerging safety data of the combination.
Pharmaceutical form:Capsule Route of administration: Oral
Pharmaceutical form:Sterile Lyophilized powder for reconstitution Route of administration: Infusion
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04418661
|Contact: Trial Transparency email recommended (Toll free number for US & Canada)||800-633-1610 ext option 6||Contact-US@sanofi.com|
|United States, California|
|Investigational Site Number 8400002||Recruiting|
|Orange, California, United States, 92868|
|United States, Texas|
|Investigational Site Number 8400001||Recruiting|
|Houston, Texas, United States, 77030|
|Investigational Site Number 0360003||Recruiting|
|Heidelberg West, Australia, 3081|
|Investigational Site Number 0360002||Recruiting|
|Randwick, Australia, 2031|
|Investigational Site Number 0360001||Recruiting|
|Woolloongabba, Australia, 4102|
|Korea, Republic of|
|Investigational Site Number 4100001||Recruiting|
|Seoul, Korea, Republic of, 03722|
|Investigational Site Number 7240001||Recruiting|
|Madrid / Madrid, Spain, 28040|
|Investigational Site Number 7240002||Recruiting|
|Madrid / Madrid, Spain, 28050|
|Investigational Site Number 1580002||Recruiting|
|Tainan, Taiwan, 704|
|Investigational Site Number 1580001||Recruiting|
|Taipei, Taiwan, 100|
|Study Director:||Clinical Sciences & Operations||Sanofi|