Trial Title:
Study of BBO-8520 in Adult Subjects with KRASG12C Non-small Cell Lung and Colorectal Cancer
NCT ID:
NCT06343402
Condition:
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
Conditions: Official terms:
Carcinoma
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Colorectal Neoplasms
Colonic Neoplasms
Pembrolizumab
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Intervention model description:
Phase 1a: sequential/parallel, Phase 1b: parallel
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
BBO-8520
Description:
Participants will receive assigned dose of BBO-8520 orally (PO), QD
Arm group label:
Cohort 1a - Dose Escalation/Dose Finding Monotherapy
Arm group label:
Cohort 1b - Dose Escalation/Dose Finding Combination Therapy
Arm group label:
Cohort 2a - Dose Expansion Monotherapy
Arm group label:
Cohort 2b - Dose Expansion Combination Therapy
Intervention type:
Drug
Intervention name:
Pembrolizumab
Description:
Patients will receive IV pembrolizumab
Arm group label:
Cohort 1b - Dose Escalation/Dose Finding Combination Therapy
Arm group label:
Cohort 2b - Dose Expansion Combination Therapy
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 and colorectal cancer
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
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of California - San Diego Moores Cancer Center
Address:
City:
La Jolla
Zip:
92093
Country:
United States
Status:
Recruiting
Facility:
Name:
UCLA Health - Santa Monica Cancer Care
Address:
City:
Santa Monica
Zip:
90404
Country:
United States
Status:
Recruiting
Facility:
Name:
Yale Cancer Center
Address:
City:
New Haven
Zip:
06510
Country:
United States
Status:
Recruiting
Facility:
Name:
Norwalk Hospital
Address:
City:
Norwalk
Zip:
06850
Country:
United States
Status:
Recruiting
Facility:
Name:
University of Kansas Medical Center
Address:
City:
Kansas City
Zip:
66205
Country:
United States
Status:
Recruiting
Facility:
Name:
Cleveland Clinic
Address:
City:
Cleveland
Zip:
44195
Country:
United States
Status:
Recruiting
Facility:
Name:
SCRI Oncology Partners
Address:
City:
Nashville
Zip:
37203
Country:
United States
Status:
Recruiting
Facility:
Name:
Huntsman Cancer Institute
Address:
City:
Salt Lake City
Zip:
84112
Country:
United States
Status:
Recruiting
Facility:
Name:
NEXT Oncology
Address:
City:
Fairfax
Zip:
22031
Country:
United States
Status:
Recruiting
Facility:
Name:
Fred Hutchinson Cancer Center
Address:
City:
Seattle
Zip:
98109
Country:
United States
Status:
Recruiting
Facility:
Name:
Kinghorn Cancer Centre
Address:
City:
Darlinghurst
Zip:
2010
Country:
Australia
Status:
Recruiting
Facility:
Name:
Flinders Medical Centre
Address:
City:
Bedford Park
Zip:
5042
Country:
Australia
Status:
Recruiting
Facility:
Name:
The Queen Elizabeth Hospital
Address:
City:
Woodville South
Zip:
5011
Country:
Australia
Status:
Recruiting
Facility:
Name:
Peninsula & South Eastern Hematology and Oncology Group (PAS)
Address:
City:
Frankston
Zip:
3199
Country:
Australia
Status:
Recruiting
Facility:
Name:
Peter MacCallum Cancer Centre
Address:
City:
Melbourne
Zip:
3051
Country:
Australia
Status:
Recruiting
Start date:
May 22, 2024
Completion date:
February 2028
Lead sponsor:
Agency:
TheRas, Inc., d/b/a BridgeBio Oncology Therapeutics
Agency class:
Industry
Source:
TheRas, Inc., d/b/a BridgeBio Oncology Therapeutics
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06343402
