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Purpose

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 in subjects with locally advanced and unresectable or metastatic non-small cell lung cancer with a KRAS (Kirsten rat sarcoma) G12C mutation.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Histologically documented locally advanced and unresectable or metastatic non-small cell lung cancer with a KRAS G12C mutation - Measurable disease by RECIST v1.1 - Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1

Exclusion Criteria

  • Patients with malignancy within the last 2 years as specified in the protocol - Patients with untreated brain metastases - Patients with known hypersensitivity to BBO-8520 or its excipients - For Cohorts 1b and 2b: - Patients with a known hypersensitivity to pembrolizumab or its excipients - Patients with active autoimmune disease of history of autoimmune disease that might recur - Patients with a history of interstitial lung disease/pneumonitis that required steroids, or current interstitial lung disease/pneumonitis Other inclusion/exclusion criteria may apply

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Sequential Assignment
Intervention Model Description
Phase 1a: sequential/parallel, Phase 1b: parallel
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Cohort 1a - Dose Escalation/Dose Finding Monotherapy 		Participants enrolled in this cohort will receive BBO-8520 (different dose levels will be evaluated) once a day (QD) as monotherapy
  • Drug: BBO-8520
    Participants will receive assigned dose of BBO-8520 orally (PO), QD
Experimental
Cohort 1b - Dose Escalation/Dose Finding Combination Therapy 		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)
  • Drug: BBO-8520
    Participants will receive assigned dose of BBO-8520 orally (PO), QD
  • Drug: Pembrolizumab
    Patients will receive IV pembrolizumab
Experimental
Cohort 2a - Dose Expansion Monotherapy 		Participants enrolled in this cohort will receive BBO-8520 once a day (QD) as monotherapy
  • Drug: BBO-8520
    Participants will receive assigned dose of BBO-8520 orally (PO), QD
Experimental
Cohort 2b - Dose Expansion Combination Therapy 		Participants enrolled in this cohort will receive BBO-8520 once a day (QD) in combination with pembrolizumab infusion (IV)
  • Drug: BBO-8520
    Participants will receive assigned dose of BBO-8520 orally (PO), QD
  • Drug: Pembrolizumab
    Patients will receive IV pembrolizumab

Recruiting Locations

University of Kansas Medical Center
Kansas City, Kansas 66205

More Details

Status
Recruiting
Sponsor
TheRas, Inc., d/b/a BridgeBio Oncology Therapeutics

Study Contact

TheRas, Inc. d/b/a BridgeBio Oncology Therapeutics
650-391-9740
onkoras-101ct.gov@bridgebiooncology.com

Detailed Description

This is an open-label, multi-center, Phase 1 study designed to evaluate the safety, tolerability, pharmacokinetics, and efficacy of BBO-8520, a direct inhibitor of KRASG12C (ON and OFF), alone and in combination with the ICI pembrolizumab in subjects with locally advanced and unresectable or metastatic non-small cell lung cancer with a KRAS (Kirsten rat sarcoma) G12C mutation. The study includes dose escalation phase and dose expansion phase

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.