A Phase 1 Study of INCB099280 in Combination With Adagrasib in Adults With Advanced Solid Tumors Harboring a KRASG12C Mutation

Conditions

Advanced Solid Tumors Harboring a KRASG12C Mutation

Brief summary

DLTs., TEAEs., Impact of TEAEs on study drug administration, assessed by treatment interruptions, dose reductions, and permanent discontinuation.

Detailed description

Descriptive summary of PK concentration data for INCB099280 and adagrasib., INCB099280 PK parameters including Cmax,ss, Tmax,ss, Cmin,ss, AUC0-12h, CL/F, and Vz/F from observed INCB099280 plasma concentration time profiles, summarized and analyzed for DDIs., Objective response, defined as having a best overall response of CR or PR assessed per RECIST v1.1 by the investigator., Disease control, defined as having a best overall response of CR, PR, or SD ≥ 15 weeks (from the start of treatment) assessed per RECIST v1.1 by the investigator., DOR, defined as the time from the first CR or PR until disease progression (assessed per RECIST v1.1 by the investigator) or death from any cause, whichever occurs earlier., Six-month and 12-month PFS, defined as absence of disease progression (assessed per RECIST v1.1 by the investigator) or death from any cause from start of treatment to 6 or 12 months.

Related papers

No related papers found yet.

Interventions

DRUGINCB099280

DRUGAdagrasib

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
DLTs., TEAEs., Impact of TEAEs on study drug administration, assessed by treatment interruptions, dose reductions, and permanent discontinuation.	—

Secondary

Measure	Time frame
Descriptive summary of PK concentration data for INCB099280 and adagrasib., INCB099280 PK parameters including Cmax,ss, Tmax,ss, Cmin,ss, AUC0-12h, CL/F, and Vz/F from observed INCB099280 plasma concentration time profiles, summarized and analyzed for DDIs., Objective response, defined as having a best overall response of CR or PR assessed per RECIST v1.1 by the investigator., Disease control, defined as having a best overall response of CR, PR, or SD ≥ 15 weeks (from the start of treatment) assessed per RECIST v1.1 by the investigator., DOR, defined as the time from the first CR or PR until disease progression (assessed per RECIST v1.1 by the investigator) or death from any cause, whichever occurs earlier., Six-month and 12-month PFS, defined as absence of disease progression (assessed per RECIST v1.1 by the investigator) or death from any cause from start of treatment to 6 or 12 months.	—

Measure

Time frame

Descriptive summary of PK concentration data for INCB099280 and adagrasib., INCB099280 PK parameters including Cmax,ss, Tmax,ss, Cmin,ss, AUC0-12h, CL/F, and Vz/F from observed INCB099280 plasma concentration time profiles, summarized and analyzed for DDIs., Objective response, defined as having a best overall response of CR or PR assessed per RECIST v1.1 by the investigator., Disease control, defined as having a best overall response of CR, PR, or SD ≥ 15 weeks (from the start of treatment) assessed per RECIST v1.1 by the investigator., DOR, defined as the time from the first CR or PR until disease progression (assessed per RECIST v1.1 by the investigator) or death from any cause, whichever occurs earlier., Six-month and 12-month PFS, defined as absence of disease progression (assessed per RECIST v1.1 by the investigator) or death from any cause from start of treatment to 6 or 12 months.

—

Countries

France, Italy, Spain

Outcome results

None listed