Study of BBO-8520 in Adult Subjects with KRASG12C Non-small Cell Lung and Colorectal Cancer

Purpose

A first in human study to evaluate the safety, tolerability, and pharmacokinetics (PK) of BBO-8520, a KRAS G12C (ON) inhibitor, single agent and in combination with pembrolizumab in patients with advanced non-small cell lung cancer and colorectal cancer

Conditions

  • Non-small Cell Lung Cancer
  • Metastatic Non-Small Cell Lung Cancer
  • NSCLC
  • KRAS G12C
  • Metastatic Lung Cancer
  • Advanced Lung Carcinoma
  • Colorectal Cancer
  • Metastatic Colorectal Cancer
  • CRC
  • Advanced Colorectal Carcinoma
  • Metastatic Colon Cancer
  • Colon Cancer

Eligibility

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

Inclusion Criteria

  • Histologically documented locally advanced or metastatic non-small cell lung cancer or colorectal 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 2a 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 d/b/a BridgeBio Oncology Therapeutics
650-391-9740
onkoras-101ct.gov@bridgebiooncology.com

Detailed Description

This is an open-label, multi-center Phase 1a/1b study designed to evaluate the safety, tolerability, preliminary antitumor activity, and PK of BBO-8520 as a single agent and in combination with pembrolizumab in patients with KRAS (Kirsten rat sarcoma) G12C mutant non-small cell lung cancer and colorectal cancer. The study includes dose escalation phase and dose expansion phase