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

Non-small Cell Lung Cancer Clinical Trial

Official title:

A Phase 1a/1b Open-Label Study of BBO-8520 Monotherapy and BBO-8520 in Combination With Pembrolizumab in Subjects With Advanced KRASG12C Mutant Non-Small Cell Lung Cancer - the ONKORAS-101 Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06343402
• Other study ID #: TBBO8520-101
• Secondary ID: ONKORAS-101
• Status: Recruiting
• Phase: Phase 1
• Start date: May 22, 2024
• Est. completion date: February 2028

Study information

• Verified date: May 2024
• Source: TheRas, Inc., d/b/a BridgeBio Oncology Therapeutics
• Contact: TheRas
• Phone: 650-391-9740
• Email: onkoras-101ct.gov[@]bridgebiooncology.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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. The study includes dose escalation phase, and expansion phase

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: February 2028
• Est. primary completion date: August 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Histologically documented locally advanced 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 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

Related Conditions & MeSH terms

• Advanced Lung Carcinoma
• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Metastatic Lung Cancer
• Metastatic Non-Small Cell Lung Cancer
• Non-small Cell Lung Cancer
• NSCLC

Intervention

Drug:
• BBO-8520
Participants will receive assigned dose of BBO-8520 orally (PO), QD
• Pembrolizumab
Patients will receive IV pembrolizumab

Locations

Country	Name	City	State
Australia	Peninsula & South Eastern Hematology and Oncology Group (PAS)	Frankston	Victoria
Australia	Peter MacCallum Cancer Centre	Melbourne	Victoria
United States	Cleveland Clinic	Cleveland	Ohio
United States	NEXT Oncology	Fairfax	Virginia
United States	SCRI Oncology Partners	Nashville	Tennessee
United States	Norwalk Hospital	Norwalk	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
TheRas, Inc., d/b/a BridgeBio Oncology Therapeutics

Countries where clinical trial is conducted

United States,  Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse Events	Incidence and severity of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs)	approximately 3 years
Primary	Dose-limiting toxicities (DLTs)	Number of participants with dose limiting toxicities	approximately 3 years
Secondary	To evaluate preliminary antitumor activity of BBO-8520	Progression-free survival (PFS) per (RECIST v1.1)	approximately 3 years
Secondary	To evaluate preliminary antitumor activity of BBO-8520	Duration of response (DOR) per (RECIST v1.1)	approximately 3 years
Secondary	Overall Survival (OS)		approximately 3 years
Secondary	To characterize the pharmacokinetics (PK) of BBO-8520	Area under the curve (AUC)	approximately 3 years
Secondary	To characterize the pharmacokinetics (PK) of BBO-8520	Peak plasma drug concentration (Cmax)	approximately 3 years
Secondary	To characterize the pharmacokinetics (PK) of BBO-8520	Time to Cmax (Tmax)	approximately 3 years
Secondary	To characterize the pharmacokinetics (PK) of BBO-8520	Half life (T1/2)	approximately 3 years