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

NCT05920135 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2025-04-27

No results posted yet for this study

Summary

This is an open label, multi-center, Phase 1/2 study evaluating the safety, tolerability, PK, PD, and preliminary efficacy (antitumor activity) of BBT-207. It will consist of 3 parts; dose escalation, recommended phase 2 dose selection, and dose expansion.

Conditions

  • EGFR Mutant Advanced Non-Small Cell Lung Cancer

Interventions

DRUG

BBT-207

BBT-207 given orally alone

Sponsors & Collaborators

  • Bridge Biotherapeutics, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-11
Primary Completion
2026-08-01
Completion
2028-08-01
FDA Drug
Yes

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05920135 on ClinicalTrials.gov