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BBT-207 for Non-Small Cell Lung Cancer

Phase 1 & 2

Recruiting

Research Sponsored by Bridge Biotherapeutics, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Histologically or cytologically confirmed Stage III (locally advanced) NSCLC not amenable to curative therapy or stage IV NSCLC

Patients must have received treatment with at least 1 third-generation EGFR TKI (eg, Osimertinib, Lazertinib)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately 3 years

Awards & highlights

Study Summary

This trial will assess safety, effectiveness of a new cancer drug, BBT-207, and how it's absorbed and works in the body.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

While the exact side effects of BBT-207 aren't listed here since it's a first-in-human study, common ones for new cancer drugs may include nausea, fatigue, skin reactions, diarrhea or constipation. Organ inflammation and blood count changes could also occur.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I have been treated with a specific lung cancer medication like Osimertinib.

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I am fully active or can carry out light work.

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My cancer didn't grow for at least 4 months after starting treatment with an EGFR inhibitor.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~approximately 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 3 years 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] Determine Recommended Dose Range

[Phase 1a dose escalation] Incidence of Treatment-Emergent Adverse Events, Adverse Events of Special Interest, Serious Adverse Events, and ≥grade 3 laboratory abnormalities.

[Phase 1b Recommended Phase 2 Dose selection] Determine the RP2D

+1 more

Secondary outcome measures

[Phase 1a, Phase 1b, Phase 2] Area under the concentration-time curve from time zero to the time with last measurable concentration [AUC0-t]

[Phase 1a, Phase 1b, Phase 2] DCR per RECIST Version 1.1, measured as percentage of patients with CR + PR + (SD ≥16 weeks)

[Phase 1a, Phase 1b, Phase 2] Duration of Response [DOR] defined as the time from the first dose of BBT207 to disease progression or death in patients who achieve complete or partial response per RECIST Version 1.1

+15 more

Trial Design

3Treatment groups

Experimental Treatment

Group I: Phase 2; At the recommended phase 2 dose of BBT-207 in patients with EGFR C797S mutationExperimental Treatment1 Intervention

Group II: Phase 1b; At 2 recommended dose levels of BBT-207 in patients with EGFR C797S mutationExperimental Treatment1 Intervention

Group III: Phase 1a; Dose escalation at various dose levels in patients with EGFR TKI sensitizing mutationExperimental Treatment1 Intervention

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Bridge Biotherapeutics, Inc.Lead Sponsor

9 Previous Clinical Trials

461 Total Patients Enrolled

Frequently Asked Questions

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

Are there any open enrollments for this research endeavor?

"Affirmative. The information available on clinicaltrials.gov verifies that this research endeavour is currently enrolling participants. It first appeared online on September 11th 2023 and has been updated most recently November 8th of the same year; 92 individuals need to be recruited from 4 specified sites."

Answered by AI

What is the current participant count for this research?

"Affirmative, the information posted on clinicaltrials.gov indicates that this experiment is actively enrolling patients. Initially put up on September 11th 2023 and most recently updated November 8th 2023, 92 individuals are needed from 4 different sites for participation."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

First-in-Human Study of BBT-207 in Advanced Non-Small Cell Lung Cancer Harboring EGFR Mutation After Treatment With EGFR TKI

2023. "First-in-Human Study of BBT-207 in Advanced Non-Small Cell Lung Cancer Harboring EGFR Mutation After Treatment With EGFR TKI". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05920135.

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