This is a Phase Ib study that will evaluate the Safety, Tolerability , Pharmacokinetics, Activity and Immunogenicity of HS-10370 in Combination With Other Anti-cancer Therapies in Chinese patients with KRAS G12C mutation advanced or metastatic solid tumors, especially in and Colorectal cancer(CRC) and non-Small cell lung cancer (NSCLC).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
762
Participants will receive HS-10370 dose 1 administered orally
Participants will receive HS-20117 given as dose 3 intravenous infusion(IV) once every 14-day cycle.
Participants will receive Adebrelimab intravenous infusion(IV) once every 21-day cycle
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, China
Sun Yat-sen University Cancer Center
Shanghai, China
Number of Participants with Adverse Event(s) (AEs)
An adverse event (AE) is defined as any untoward medical occurrence in a patient and which does not necessarily have a causal relationship with this treatment. Severity is determined according to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0)
Time frame: From Cycle 1 Day 1 (C1D1) to disease progression or death, up to 2 years (each cycle is 14 days).
Overall Response Rate (ORR)
Percentage of Participants who Achieve a Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR).ORR by the Investigator According to RECIST v1.1
Time frame: From Cycle 1 Day 1 (C1D1) to disease progression or death, up to 2 years (each cycle is 14 days).
Disease Control Rate (DCR)
Percentage of Participants who Achieve a BOR of CR, PR, or Stable Disease (SD).DCR by the Investigator According to RECIST v1.1
Time frame: From Cycle 1 Day 1 (C1D1) to disease progression or death, up to 2 years (each cycle is 14 days).
Time to Response (TTR)
TTR by the Investigator According to RECIST v1.1
Time frame: Time from Cycle 1 Day 1 until the date that measurement criteria for CR or PR (whichever is first recorded) are first met, up to 2 years (each cycle is 14 days).
Duration of Response (DOR)
DOR by the Investigator According to RECIST v1.1
Time frame: Date of first evidence of CR or PR to date of disease progression or death from any cause, approximately 2 years
Progression-Free Survival (PFS)
PFS by the Investigator According to RECIST v1.1
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Participants will receive Capecitabine administered orally
Participants will receive Oxaliplatin intravenous infusion(IV) once every 21-day cycle.
Participants will receive Folinic Acid, Fluorouracil and Oxaliplatin/Irinotecan intravenous infusion(IV) once every 14-day cycle.
Participants will receive HS-20093 intravenous infusion(IV) once every 21-day cycle
Participants will receive platinum (cisplatin or carboplatin) administered IV in 21-day cycles.
Time frame: Date of first evidence of CR or PR to date of disease progression or death from any cause, approximately 2 years
Overall survival (OS)
Defined as the time from C1D1 to death from any cause by the Investigator According to RECIST v1.1
Time frame: Cycle 1 Day 1 to date of death from any cause, up to 5 years (each cycle is 14 days)
Plasma Concentrations of HS-10370
Defined as the time from C1D1 to death from any cause
Time frame: Cycle 1 Day 1 to date of death from any cause. Various timepoints from Cycle 1 Day 1 through study treatment discontinuation, up to 2 years. (each cycle is 14 days)
Maximum plasma concentration (Cmax)
Cmax is defined as maximum observed serum concentration obtained directly from the observed concentration-time data.
Time frame: Cycle 1 Day 1 to date of death from any cause, up to 2 years. Various timepoints from Cycle 1 Day 1 through study treatment discontinuation (each cycle is 14 days)
Time of maximum concentration (Tmax)
Tmax is defined as the time required for a drug to reach peak concentration in plasma.
Time frame: Cycle 1 Day 1 to date of death from any cause, up to 2 years. Various timepoints from Cycle 1 Day 1 through study treatment discontinuation (each cycle is 14 days)