Spots Global Cancer Trial Database for Dose Escalation and Expansion Study of SAR444200-based Regimen in Adult Participants With Advanced Solid Tumors
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Trial Identification
Brief Title: Dose Escalation and Expansion Study of SAR444200-based Regimen in Adult Participants With Advanced Solid Tumors
Official Title: A Phase 1/2 Open-label, First-in-human, Dose Escalation and Expansion Study for the Evaluation of Safety, Pharmacokinetics, Pharmacodynamics, and Anti-tumor Activity of SAR444200-based Regimen in Participants With Advanced Solid Tumors.
Study ID: NCT05450562
Conditions
Study Description
Brief Summary: This is Phase 1/Phase 2, open label, multiple cohort, first-in-human study to evaluate safety, PK, PDy and efficacy of SAR444200 as a monotherapy or in combination with other anti-cancer agents for participants aged at least 18 years with previously treated metastatic malignancies.
Detailed Description: Treatment Period: enrolled participants will receive continuous treatment until disease progression (PD), unacceptable adverse event (AE), or other permanent discontinuation criteria. The End of Treatment visit will occur 30 days ±7 days from last IMP administration or prior to initiation of further therapy, whichever occurs first.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
USCA Norris Comprehensive Cancer Center Site Number : 8400004, Los Angeles, California, United States
Mount Sinai Hospital Site Number : 8400005, New York, New York, United States
Lifespan Site Number : 8400002, Providence, Rhode Island, United States
~MD Anderson Cancer Center Site Number : 8400003, Houston, Texas, United States
Investigational Site Number : 1240002, Toronto, Ontario, Canada
Investigational Site Number : 1240001, Quebec, , Canada
Investigational Site Number : 1560001, Shanghai, , China
Investigational Site Number : 1560002, Wuhan, , China
Investigational Site Number : 4100002, Seoul, Seoul-teukbyeolsi, Korea, Republic of
Investigational Site Number : 4100001, Seoul, Seoul-teukbyeolsi, Korea, Republic of
Investigational Site Number : 7020002, Singapore, , Singapore
Investigational Site Number : 7020003, Singapore, , Singapore
Investigational Site Number : 7020001, Singapore, , Singapore
Contact Details
Name: Clinical Sciences & Operations
Affiliation: Sanofi
Role: STUDY_DIRECTOR
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