Open-label Study of BBO-8520 in Adult Subjects With KRASG12C Non-small Cell Lung Cancer
- Conditions
- Non-small Cell Lung CancerMetastatic Non-Small Cell Lung CancerNSCLCKRAS G12CMetastatic Lung CancerAdvanced Lung Carcinoma
- Interventions
- Registration Number
- NCT06343402
- Lead Sponsor
- TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics)
- Brief 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 in subjects with locally advanced and unresectable or metastatic non-small cell lung cancer with a KRAS (Kirsten rat sarcoma) G12C mutation.
- 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
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 250
- 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
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Cohort 1a - Dose Escalation/Dose Finding Monotherapy BBO-8520 Participants enrolled in this cohort will receive BBO-8520 (different dose levels will be evaluated) once a day (QD) as monotherapy Cohort 1b - Dose Escalation/Dose Finding Combination Therapy Pembrolizumab 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) Cohort 2b - Dose Expansion Combination Therapy Pembrolizumab Participants enrolled in this cohort will receive BBO-8520 once a day (QD) in combination with pembrolizumab infusion (IV) Cohort 1b - Dose Escalation/Dose Finding Combination Therapy BBO-8520 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) Cohort 2a - Dose Expansion Monotherapy BBO-8520 Participants enrolled in this cohort will receive BBO-8520 once a day (QD) as monotherapy Cohort 2b - Dose Expansion Combination Therapy BBO-8520 Participants enrolled in this cohort will receive BBO-8520 once a day (QD) in combination with pembrolizumab infusion (IV)
- Primary Outcome Measures
Name Time Method Adverse Events approximately 3 years Incidence and severity of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs)
Dose-limiting toxicities (DLTs) approximately 3 years Number of participants with dose limiting toxicities
- Secondary Outcome Measures
Name Time Method To characterize the pharmacokinetics (PK) of BBO-8520 approximately 3 years Half life (T1/2)
To evaluate preliminary antitumor activity of BBO-8520 approximately 3 years Progression-free survival (PFS) per (RECIST v1.1)
Overall Survival (OS) approximately 3 years
Trial Locations
- Locations (15)
University of California - San Diego Moores Cancer Center
🇺🇸La Jolla, California, United States
UCLA Health - Santa Monica Cancer Care
🇺🇸Santa Monica, California, United States
Yale Cancer Center
🇺🇸New Haven, Connecticut, United States
Norwalk Hospital
🇺🇸Norwalk, Connecticut, United States
University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
SCRI Oncology Partners
🇺🇸Nashville, Tennessee, United States
Huntsman Cancer Institute
🇺🇸Salt Lake City, Utah, United States
NEXT Oncology
🇺🇸Fairfax, Virginia, United States
Fred Hutchinson Cancer Center
🇺🇸Seattle, Washington, United States
Scroll for more (5 remaining)University of California - San Diego Moores Cancer Center🇺🇸La Jolla, California, United States