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SHP2 Inhibitor

BBP-398 + Nivolumab for Lung Cancer

Phase 1
Recruiting
Research Sponsored by Navire Pharma Inc., a BridgeBio company
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients must have progression or disease recurrence on or after at least one prior line of systemic therapy, which must include platinum-based doublet chemotherapy and anti-PD-(L)1 therapy.
Patients must have histologically documented, locally advanced and unresectable, or metastatic NSCLC with documentation of a KRAS mutation within the 1 year prior to screening.
Must not have
Patients that have received any live/attenuated vaccine within 30 days of first study treatment.
Patients that have a condition requiring systemic treatment with either corticosteroids (>10 mg prednisone equivalent) or other immunosuppressive medication within 14 days of study start.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up completion of 1 cycle (28 days)
Awards & highlights

Summary

This trial is testing a new cancer drug, BBP-398, to see if it is safe and effective when used with another cancer drug, nivolumab.

Who is the study for?
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.Check my eligibility
What is being tested?
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).See study design
What are the potential side effects?
Possible side effects include immune system reactions affecting organs, fatigue, skin problems, muscle or joint pain. Nivolumab can also cause infusion-related reactions and complications from activating the immune system against normal tissues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer has worsened after treatment including platinum chemotherapy and anti-PD-(L)1 therapy.
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My advanced lung cancer has a KRAS mutation, confirmed within the last year.
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I am fully active or restricted in physically strenuous activity but can do light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have not received a live vaccine in the last 30 days.
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I haven't taken high-dose steroids or other immune-weakening drugs in the last 2 weeks.
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I have had a bone marrow transplant from a donor.
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I have tumors or cancer spread to my brain.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~completion of 1 cycle (28 days)
This trial's timeline: 3 weeks for screening, Varies for treatment, and completion of 1 cycle (28 days) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Phase 1a Dose Escalation: Assess safety, tolerability, and recommended phase 2 dose (RP2D) of BBP-398 in combination with nivolumab
Phase 1b Dose Expansion: Assess antitumor activity of BBP-398 in combination with nivolumab
Secondary outcome measures
Assess preliminary antitumor activity of BBP-398 in combination with nivolumab
Phase 1b Dose Expansion: Assess safety and tolerability of BBP-398 at the RP2D, in combination with nivolumab

Trial Design

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

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Non-Small Cell Lung Cancer (NSCLC) include SHP2 inhibitors and PD-1 antibodies. SHP2 inhibitors block the SHP2 protein, disrupting cancer cell growth and survival pathways. PD-1 antibodies like Nivolumab inhibit the PD-1 protein on immune cells, preventing cancer cells from evading immune detection. These targeted therapies are significant for NSCLC patients as they can reduce tumor growth and enhance the immune system's ability to fight cancer, potentially improving treatment outcomes.
Large Cell Neuro-Endocrine Carcinoma of the Lung: Current Treatment Options and Potential Future Opportunities.Management of patients with lung cancer and poor performance status.

Find a Location

Who is running the clinical trial?

Navire Pharma Inc., a BridgeBio companyLead Sponsor
2 Previous Clinical Trials
215 Total Patients Enrolled
Bristol-Myers SquibbIndustry Sponsor
2,652 Previous Clinical Trials
4,130,704 Total Patients Enrolled
Susanna Wen MsM, PhDStudy DirectorNavire Pharma Inc., a BridgeBio company

Media Library

BBP-398 (SHP2 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05375084 — Phase 1
Non-Small Cell Lung Cancer Research Study Groups: Dose Escalation Level 1, Dose Escalation Level 2, Dose Escalation Level 3, Dose Expansion
Non-Small Cell Lung Cancer Clinical Trial 2023: BBP-398 Highlights & Side Effects. Trial Name: NCT05375084 — Phase 1
BBP-398 (SHP2 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05375084 — Phase 1
~16 spots leftby Jul 2025