This is a Phase Ib study that will evaluate the Safety, Tolerability , Pharmacokinetics and Activity of HS-10370 in Combination With Other Anti-cancer Therapies in patients with KRAS G12C mutation advanced or metastatic solid tumors, especially in non-Small cell lung cancer (NSCLC) .
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
350
HS-10370 administered orally every day
Administered intravenously every 21 days; dose by label.
Administered intravenously every 21 days; dose by label.
Union Hospital Tong Ji Medical College, HuaZhong University of Science and Technology
Wuhan, Hubei, 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 to first documented progression of disease or death from any cause, approximately 2 years.
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, approximately 2 years.
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 C1D1 to disease progression or death, approximately 2 years.
Time to Response (TTR)
TTR by the Investigator According to RECIST v1.1
Time frame: Time from C1D1 until the date that measurement criteria for CR or PR (whichever is first recorded) are first met, approximately 2 years.
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
Time frame: Date of first evidence of CR or PR to date of disease progression or death from any cause, approximately 2 years.
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Administered intravenously every 21 days; dose by label.
Administered intravenously every 21 days; dose by label.
Overall survival (OS)
Defined as the time from C1D1 to death from any cause
Time frame: C1D1 to date of death from any cause, approximately 5 years.
Plasma Concentrations of HS-10370
Defined as the time from C1D1 to death from any cause
Time frame: C1D1 to date of death from any cause. Various timepoints from Cycle 1 Day 1 through study treatment discontinuation, approximately 2 years.
Maximum plasma concentration (Cmax)
Cmax is defined as maximum observed serum concentration obtained directly from the observed concentration-time data.
Time frame: C1D1 to date of death from any cause, approximately 2 years. Various timepoints from Cycle 1 Day 1 through study treatment discontinuation.
Time of maximum concentration (Tmax)
Tmax is defined as the time required for a drug to reach peak concentration in plasma.
Time frame: C1D1 to date of death from any cause, approximately 2 years. Various timepoints from Cycle 1 Day 1 through study treatment discontinuation