A Phase 1/2 Study of the Safety, Pharmacokinetics and Anti-Tumor Activity of the Oral KIT Inhibitor THE-630 in Patients with Advanced Gastrointestinal Stromal Tumors (GIST)

Conditions

Gastrointestinal Stromal Tumors (GIST)

Brief summary

Dose Escalation (Phase 1): Safety profile of oral THE-630, including identification of DLTs and MTD, and determination of the RP2D., Expansion (Phase 2): Confirmed ORR, according to modified RECIST 1.1 for patients with GIST.

Detailed description

Dose Escalation (Phase 1): Plasma PK parameters of THE-630 and its active metabolite THE-973 after single oral dose and at steady state after multiple oral doses., Dose Escalation (Phase 1): Efficacy assessments, according to modified RECIST 1.1 for patients with GIST including: confirmed ORR, best overall response, best target lesion response, time to response, DOR, DCR, CBR at 16 weeks, PFS, and OS., Expansion (Phase 2): Efficacy assessments, according to modified RECIST 1.1 for patients with GIST, including: DOR, best overall response, best target lesion response, time to response, DCR, CBR at 16 weeks, PFS, and OS., Expansion (Phase 2): Safety profile of oral THE-630., Expansion (Phase 2): Plasma PK parameters of THE-630 and its active metabolite THE-973, after a single oral dose and at steady state after multiple oral doses.

Related papers

No related papers found yet.

Interventions

DRUGTHE-630

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Secondary

Measure	Time frame
Dose Escalation (Phase 1): Plasma PK parameters of THE-630 and its active metabolite THE-973 after single oral dose and at steady state after multiple oral doses., Dose Escalation (Phase 1): Efficacy assessments, according to modified RECIST 1.1 for patients with GIST including: confirmed ORR, best overall response, best target lesion response, time to response, DOR, DCR, CBR at 16 weeks, PFS, and OS., Expansion (Phase 2): Efficacy assessments, according to modified RECIST 1.1 for patients with GIST, including: DOR, best overall response, best target lesion response, time to response, DCR, CBR at 16 weeks, PFS, and OS., Expansion (Phase 2): Safety profile of oral THE-630., Expansion (Phase 2): Plasma PK parameters of THE-630 and its active metabolite THE-973, after a single oral dose and at steady state after multiple oral doses.	—

Measure

Time frame

Dose Escalation (Phase 1): Plasma PK parameters of THE-630 and its active metabolite THE-973 after single oral dose and at steady state after multiple oral doses., Dose Escalation (Phase 1): Efficacy assessments, according to modified RECIST 1.1 for patients with GIST including: confirmed ORR, best overall response, best target lesion response, time to response, DOR, DCR, CBR at 16 weeks, PFS, and OS., Expansion (Phase 2): Efficacy assessments, according to modified RECIST 1.1 for patients with GIST, including: DOR, best overall response, best target lesion response, time to response, DCR, CBR at 16 weeks, PFS, and OS., Expansion (Phase 2): Safety profile of oral THE-630., Expansion (Phase 2): Plasma PK parameters of THE-630 and its active metabolite THE-973, after a single oral dose and at steady state after multiple oral doses.

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Primary

Measure	Time frame
Dose Escalation (Phase 1): Safety profile of oral THE-630, including identification of DLTs and MTD, and determination of the RP2D., Expansion (Phase 2): Confirmed ORR, according to modified RECIST 1.1 for patients with GIST.	—

Countries

France, Spain

Outcome results

None listed