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KRAS G12C Inhibitor

BBO-8520 + Pembrolizumab for Lung Cancer

Phase 1
Recruiting
Research Sponsored by TheRas, Inc., d/b/a BridgeBio Oncology Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 3 years
Awards & highlights
No Placebo-Only Group

Summary

"This trial is testing a new drug called BBO-8520 to see if it is safe and well-tolerated in patients with advanced lung cancer. They will also be looking at how the drug

Who is the study for?
This trial is for adults with a specific mutation in their lung cancer cells (KRASG12C). Participants should have advanced non-small cell lung cancer that has progressed despite previous treatment. The study excludes individuals who don't meet the health requirements or have conditions that could interfere with the drug's effects.
What is being tested?
The trial is testing BBO-8520, a new potential drug targeting KRAS G12C mutations in lung cancer cells. It will be given alone and alongside pembrolizumab, an existing cancer therapy, to evaluate safety, how well it's tolerated by patients, and its behavior in the body.
What are the potential side effects?
Possible side effects may include typical reactions to cancer treatments such as fatigue, nausea, skin issues or allergic reactions. Pembrolizumab can also cause immune system-related side effects like inflammation of organs.

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Adverse Events
Dose-limiting toxicities (DLTs)
Secondary study objectives
To characterize the pharmacokinetics (PK) of BBO-8520
To evaluate preliminary antitumor activity of BBO-8520

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups
Experimental Treatment
Group I: Cohort 2b - Dose Expansion Combination TherapyExperimental Treatment2 Interventions
Participants enrolled in this cohort will receive BBO-8520 once a day (QD) in combination with pembrolizumab infusion (IV)
Group II: Cohort 2a - Dose Expansion MonotherapyExperimental Treatment1 Intervention
Participants enrolled in this cohort will receive BBO-8520 once a day (QD) as monotherapy
Group III: Cohort 1b - Dose Escalation/Dose Finding Combination TherapyExperimental Treatment2 Interventions
Participants enrolled in this cohort will receive BBO-8520 (different dose levels will be evaluated) once a day (QD) in combination with pembrolizumab infusion (IV)
Group IV: Cohort 1a - Dose Escalation/Dose Finding MonotherapyExperimental Treatment1 Intervention
Participants enrolled in this cohort will receive BBO-8520 (different dose levels will be evaluated) once a day (QD) as monotherapy
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 3
~3150

Find a Location

Who is running the clinical trial?

TheRas, Inc., d/b/a BridgeBio Oncology TherapeuticsLead Sponsor
1 Previous Clinical Trials
153 Total Patients Enrolled
TheRas, IncLead Sponsor
~153 spots leftby Aug 2027
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