BBP-398 + Nivolumab for Lung Cancer

Recruiting in Palo Alto (17 mi)

+15 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Navire Pharma Inc., a BridgeBio company

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?This trial tests BBP-398 and nivolumab in patients with advanced lung cancer who have a specific genetic mutation and haven't responded to other treatments. BBP-398 blocks a protein that helps cancer grow, while nivolumab boosts the immune system to fight the cancer.

Eligibility Criteria

This trial is for adults with advanced non-small cell lung cancer (NSCLC) that has a KRAS mutation. They must have tried at least one systemic therapy including chemo and anti-PD-(L)1 drugs, but their cancer came back or got worse. They need to be fairly healthy overall, able to do most activities, and expected to live more than 12 weeks.

Inclusion Criteria

My advanced lung cancer has a KRAS mutation, confirmed within the last year.

My cancer has worsened after treatment including platinum chemotherapy and anti-PD-(L)1 therapy.

My cancer got worse or came back within 3 months after stopping immunotherapy.

+4 more

Exclusion Criteria

My cancer worsened within 4 months of starting treatment with an anti-PD-(L)1 drug.

I have not received a live vaccine in the last 30 days.

I have not had extensive radiation therapy within the last month.

+5 more

Participant Groups

The study tests BBP-398 (a SHP2 inhibitor) combined with nivolumab (a PD-1 antibody). It's in early stages: first finding the right dose (Phase 1a), then seeing how well it works at that dose in more people (Phase 1b).

4Treatment groups

Experimental Treatment

Group I: Dose ExpansionExperimental Treatment1 Intervention

RP2D defined dose. Oral capsules administered in combination with nivolumab

Group II: Dose Escalation Level 3Experimental Treatment1 Intervention

Level 3 oral capsules administered in combination with nivolumab

Group III: Dose Escalation Level 2Experimental Treatment1 Intervention

Level 2 oral capsules administered in combination with nivolumab

Group IV: Dose Escalation Level 1Experimental Treatment1 Intervention

Level 1 oral capsules administered in combination with nivolumab