SHP2 Inhibitor BBP-398 in Combination With Sotorasib in Patients With Advanced Solid Tumors and a KRAS-G12C Mutation

Sponsor
Navire Pharma Inc., a BridgeBio company
Study ID
NCT05480865
Phase
PHASE1
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • BBP-398 — DRUG
    BBP-398 administered orally
  • sotorasib — DRUG
    sotorasib administered orally

Study Details

This is a Phase 1 study of BBP-398, a SHP2 inhibitor, in combination with sotorasib, a KRAS-G12C inhibitor (KRAS-G12Ci), in patients with a KRAS-G12C mutation. The study involves 2 parts: Phase 1a Dose Escalation and Phase 1b Dose Expansion/Optimization.

Key Dates

Start date
Jul 6, 2022
Status verified
Dec 2024
Primary completion
Aug 22, 2024
Completion
Aug 22, 2024

Study Design

Enrollment
28 participants (actual)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose Escalation: BBP-398 Level 1 and sotorasib
    BBP-398 dose Level 1 capsules administered once a day (QD) for a 28-day treatment cycle in combination with sotorasib tablets administered once a day (QD) for a 28-day treatment cycle
  • Experimental: Dose Escalation: BBP-398 Level 2 and sotorasib
    BBP-398 dose Level 2 capsules administered once a day (QD) for a 28-day treatment cycle in combination with sotorasib tablets administered once a day (QD) for a 28-day treatment cycle
  • Experimental: Dose Escalation: BBP-398 Level 3 and sotorasib
    BBP-398 dose Level 3 capsules administered once a day (QD) for a 28-day treatment cycle in combination with sotorasib tablets administered once a day (QD) for a 28-day treatment cycle
  • Experimental: Dose Expansion/Optimization: BBP-398 Dose Regimen 1 and sotorasib
    BBP-398 Dose Regimen 1 capsules administered once a day (QD) for a 28-day treatment cycle in combination with sotorasib tablets administered once a day (QD) for a 28-day treatment cycle
  • Experimental: Dose Expansion/Optimization: BBP-398 Dose Regimen 2 and sotorasib
    BBP-398 Dose Regimen 2 capsules administered once a day (QD) for a 28-day treatment cycle in combination with sotorasib tablets administered once a day (QD) for a 28-day treatment cycle

Primary Outcome Measure

Phase 1a Dose Escalation Primary Objective: Incidence and Severity of Treatment-Emergent Adverse Events, Serious Adverse Events, and Dose Limiting Toxicities [ Time Frame: Completion of 1 Cycle (28 days) ]

Related Studies