drugset
drugset / Trial / NCT06117371

Study of BEBT-607 Tablets in The Treatment of Advanced or Metastatic Solid Tumors With KRAS G12C Mutation

NCT06117371 ↗

Phase 1 Unknown 126 enrolled BeBetter Med Inc Xiangya Hospital of Central South University · collab
Non-randomizedParallel-groupOpen-labelTreatment

Summary

This is a two-phase, multicenter, open phase I clinical study, with phase Ia as dose escalation phase and phase Ib as dose expansion phase, to evaluate the safety tolerability and pharmacokinetic characteristics of BEBT-607 tablets in patients with advanced or metastatic solid tumors associated with KRAS G12C mutation. To evaluate the efficacy of BEBT-607 tablets in the treatment of patients with advanced or metastatic solid tumors with KRAS G12C mutation, and to determine the recommended dose (RP2D) for Phase II clinical trials of BEBT-607 tablets in patients with advanced or metastatic solid tumors with KRAS G12C mutation.

Timeline

Start
2023-09-04
Primary completion
2025-05
Completion
2025-06

Drugs

EvaluationDrugModalityDoseRoute
Subject BEBT-607 Unknown 50 mg Oral
Subject BEBT-607 Unknown 100 mg Oral
Subject BEBT-607 Unknown 150 mg Oral
Subject BEBT-607 Unknown 200 mg Oral
Subject BEBT-607 Unknown 300 mg Oral
Subject BEBT-607 Unknown 400 mg Oral

Indications

No indication recorded.