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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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up completion of 1 cycle (28 days)
Awards & highlights

Study 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.
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My organs are functioning well.
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My cancer got worse or came back within 3 months after stopping immunotherapy.

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

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
2,631 Previous Clinical Trials
4,126,623 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the upper bound of participants for this investigation?

"Affirmative. Clinicaltrials.gov hosts evidence that this clinical trial, posted on May 1st 2022 and recently updated in mid-May, is currently recruiting patients with a target of 45 enrollees from one site."

Answered by AI

Are there still available slots for individuals to join this trial?

"Correct. According to information available on clinicaltrials.gov, this medical research was first posted on May 1st 2022 and is still actively enrolling patients. The trial requires 45 people at a single site."

Answered by AI

What have been the observed effects of combining BBP-398 and nivolumab in clinical trials?

"Due to this being an early stage trial, the safety of BBP-398 with nivolumab has been estimated at 1 on a scale of one to three. This is because there are scant data regarding its efficacy and security profile."

Answered by AI
~7 spots leftby Jul 2024