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Open-label Study of BBO-8520 in Adult Subjects With KRASG12C Non-small Cell Lung Cancer

NCT06343402 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 350

Last updated 2026-05-05

No results posted yet for this study

Summary

A first in human study to evaluate the safety and preliminary antitumor activity of BBO-8520, a KRAS G12C (ON and OFF) inhibitor, as a single agent and in combination with pembrolizumab and BBO-10203 in subjects with locally advanced and unresectable or metastatic non-small cell lung cancer with a KRAS (Kirsten rat sarcoma) G12C mutation.

Conditions

Interventions

DRUG

BBO-8520

Participants will receive assigned dose of BBO-8520 orally (PO), QD

DRUG

Pembrolizumab

Patients will receive IV pembrolizumab

DRUG

BBO-10203

Participants will receive assigned dose of BBO-8520 orally (PO), QD

Sponsors & Collaborators

  • TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics)

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-22
Primary Completion
2031-04-30
Completion
2031-09-30
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Canada
  • Denmark
  • Spain

Study Locations

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Entities

Drugs
Diseases

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 NCT06343402 on ClinicalTrials.gov