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KRAS G12C Inhibitor

Cohort 2b - Dose Expansion Combination Therapy for Lung Cancer

Phase 1

Recruiting

Research Sponsored by TheRas, Inc

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

Study 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.Check my eligibility

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.See study design

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 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

Adverse Events

Dose-limiting toxicities (DLTs)

Secondary outcome measures

Overall Survival (OS)

To characterize the pharmacokinetics (PK) of BBO-8520

To evaluate preliminary antitumor activity of BBO-8520

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 2

~2010

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

TheRas, IncLead Sponsor

Frequently Asked Questions

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

Is this medical study currently open for enrollment?

"As per clinicaltrials.gov, this research is actively pursuing participants. The trial was initially shared on April 1st, 2024 and the most recent update was also on April 1st, 2024."

Answered by AI

What is the current number of participants being recruited for this research endeavor?

"Yes, information on clinicaltrials.gov confirms that this trial is currently enrolling subjects. The trial was first listed on April 1st, 2024 and was last modified on the same date. It aims to recruit a total of 160 participants from two designated sites."

Answered by AI

Has Cohort 1a - Dose Escalation/Dose Finding Monotherapy been granted approval by the FDA?

"The safety rating for Cohort 1a - Dose Escalation/Dose Finding Monotherapy is rated at level 1 by our team due to the preliminary nature of this Phase I trial, indicating minimal data supporting both safety and efficacy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2024. "Study of BBO-8520 in Adult Subjects With KRASG12C Non-small Cell Lung Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06343402.

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