BBT-207 for Non-Small Cell Lung Cancer
What You Need to Know Before You Apply
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.
Are You a Good Fit for This Trial?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Dose Escalation
Phase 1a involves dose escalation at various dose levels in patients with EGFR TKI sensitizing mutation to determine the recommended dose range
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
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
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- BBT-207
Find a Clinic Near You
Who Is Running the Clinical Trial?
Bridge Biotherapeutics, Inc.
Lead Sponsor