TerminatedPhase 1

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

Stopped: Business Reasons

Australia28 participantsStarted 2022-07-06

Plain-language summary

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.

Who can participate

Age range18 Years – 99 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Key Inclusion Criteria: * Patients must have histologically documented, locally advanced and unresectable, or metastatic solid tumor with documentation of a KRAS-G12C mutation within 2 years prior to screening. * Patients must have measurable disease by RECIST v1.1. * Patients must have a minimum life expectancy of \>12 weeks after start of study treatment. * Patients must have progression or disease recurrence on or after all available standard of care therapies. * Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1. * Patients must have adequate organ function. Key Exclusion Criteria: * Patients that have participated in an interventional clinical study within the last 4 weeks. * Patients that have received radiotherapy or proton therapy with a limited field of radiation for palliation within 1 week of the start of study treatment, OR radiation to more than 30% of the bone marrow or with a wide field of radiation within 4 weeks of the start of study treatment. * Patients with untreated and/or active CNS metastases. * Patients that have a history of allogenic bone marrow transplant.

What they're measuring

Phase 1a Dose Escalation Primary Objective: Incidence and Severity of Treatment-Emergent Adverse Events, Serious Adverse Events, and Dose Limiting Toxicities

Timeframe: Completion of 1 Cycle (28 days)

Phase 1b Dose Expansion/Optimization Primary Objective: Incidence and Severity of Treatment-Emergent Adverse Events, and Serious Adverse Events

Timeframe: Completion of 1 Cycle (28 days)

Phase 1b Dose Expansion/Optimization Primary Objective: Overall Response Rate (ORR)

Timeframe: 8 weeks

Trial details

NCT IDNCT05480865

SponsorNavire Pharma Inc., a BridgeBio company

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-08-22

View on ClinicalTrials.gov More Solid Tumor, Adult trials

Who can participate

Age range18 Years – 99 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Phase 1a Dose Escalation Primary Objective: Incidence and Severity of Treatment-Emergent Adverse Events, Serious Adverse Events, and Dose Limiting Toxicities

Timeframe: Completion of 1 Cycle (28 days)

Phase 1b Dose Expansion/Optimization Primary Objective: Incidence and Severity of Treatment-Emergent Adverse Events, and Serious Adverse Events

Timeframe: Completion of 1 Cycle (28 days)

Phase 1b Dose Expansion/Optimization Primary Objective: Overall Response Rate (ORR)

Timeframe: 8 weeks