What side effects are associated with this type of intervention?

Common treatments for Non-Small Cell Lung Cancer (NSCLC) include PD-1 inhibitors like Nivolumab, which are associated with side effects such as pneumonitis, fatigue, rash, and diarrhea. Chemotherapy, often used in combination with immunotherapy, can cause neutropenia, febrile neutropenia, and hypertension. Combination therapies, such as those involving bevacizumab or other targeted agents, may lead to additional side effects like hypertension and proteinuria. Overall, the severity of side effects can vary, with some patients experiencing grade 3-4 adverse events.

What prior FDA approvals exist?

Nivolumab, a PD-1 antibody, has been FDA-approved for the treatment of advanced NSCLC, particularly for patients who have progressed after platinum-based chemotherapy. It has shown improved overall survival and response rates compared to traditional chemotherapy agents like docetaxel. Other similar immunotherapies include Pembrolizumab, another PD-1 inhibitor, which has been approved for use in combination with chemotherapy for advanced NSCLC. Atezolizumab, a PD-L1 inhibitor, is also approved for NSCLC treatment, either alone or in combination with chemotherapy. These immunotherapies have demonstrated significant benefits in terms of overall survival and progression-free survival in various clinical trials.

What other types of research exist?

Promising alternatives to BBP-398 and Nivolumab for NSCLC patients include: 1) Pembrolizumab (another PD-1 inhibitor) combined with chemotherapy, which has shown higher response rates and progression-free survival in patients with high PD-L1 expression. 2) Atezolizumab (a PD-L1 inhibitor) combined with enzalutamide, which has shown potential benefits in progression-free survival in certain subgroups. 3) Novel agents targeting KRAS mutations, such as adagrasib or sotorasib, which have shown efficacy in KRAS-mutant NSCLC. 4) Combination therapies involving PARP inhibitors and immune checkpoint inhibitors, which are being explored for their synergistic effects.

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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

No Placebo-Only Group

Summary

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.

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.

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).

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ completion of 1 cycle (28 days)

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Phase 1b Dose Expansion: Assess antitumor activity of BBP-398 in combination with nivolumab

Secondary study objectives

Assess preliminary antitumor activity of BBP-398 in combination with nivolumab

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 7Eligibility criteria met

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.