BBT-207 for Non-Small Cell Lung Cancer

Recruiting at3 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Recruiting

Sponsor: Bridge Biotherapeutics, Inc.

Must be taking: EGFR TKIs

Must not be taking: Small molecule inhibitors

Disqualifiers: Symptomatic brain metastases, cardiac conditions, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial is testing a new drug called BBT-207 to see if it is safe and effective for treating cancer. It will involve cancer patients to determine how the drug behaves in the body and its impact on tumors. The study will be conducted over time to find the best dose and evaluate its effectiveness.

Will I have to stop taking my current medications?

The trial requires that you stop taking any EGFR TKI medications, like osimertinib or afatinib, at least 8 days before starting the study treatment. Other targeted inhibitors or chemotherapy must be stopped 14 days before, and biologic anticancer medicines 28 days before starting the trial.

Research Team

Eligibility Criteria

This trial is for adults with advanced non-small cell lung cancer (NSCLC) that has a specific EGFR mutation and has worsened after treatment with EGFR TKI therapy. Participants should have tried all standard treatments, be in relatively good physical condition (ECOG score of 0 or 1), and have tumors that responded at some point to previous EGFR TKI treatment. People can't join if they have unresolved side effects from past therapies, certain heart conditions, recent radiotherapy, or took other cancer drugs too close to the start of this study.

Inclusion Criteria

My lung cancer is at an advanced stage and cannot be cured with surgery.

My cancer has a specific EGFR mutation (C797S).

My tumor has an EGFR mutation sensitive to treatment.

Exclusion Criteria

I do not have serious heart problems or uncontrolled high blood pressure.

I have taken an EGFR inhibitor within the last 8 days.

My heart's electrical activity (QT interval) is longer than normal.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Phase 1a involves dose escalation at various dose levels in patients with EGFR TKI sensitizing mutation to determine the recommended dose range

12 months

Recommended Phase 2 Dose Selection

Phase 1b involves selecting the recommended phase 2 dose at 2 dose levels of BBT-207 in patients with EGFR C797S mutation

12 months

Dose Expansion

Phase 2 involves dose expansion at the recommended phase 2 dose of BBT-207 in patients with EGFR C797S mutation to evaluate preliminary antitumor activity

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• BBT-207 (Other)

Trial Overview BBT-207 is being tested in patients with NSCLC who no longer respond to standard treatments. The study includes dose escalation to find a safe amount, selection of an optimal Phase 2 dose, and then expansion where more people are given this chosen dose. It's open label so everyone knows they're getting BBT-207.

Participant Groups

Group I: Phase 2; At the recommended phase 2 dose of BBT-207 in patients with EGFR C797S mutation Experimental Treatment 1 Intervention

Group II: Phase 1b; At 2 recommended dose levels of BBT-207 in patients with EGFR C797S mutation Experimental Treatment 1 Intervention

Group III: Phase 1a; Dose escalation at various dose levels in patients with EGFR TKI sensitizing mutation Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Bridge Biotherapeutics, Inc.

Lead Sponsor

Trials

10

Recruited

560+