Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT06343402




Registration number
NCT06343402
Ethics application status
Date submitted
22/03/2024
Date registered
2/04/2024
Date last updated
7/06/2024

Titles & IDs
Public title
Study of BBO-8520 in Adult Subjects With KRASG12C Non-small Cell Lung Cancer
Scientific 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
Secondary ID [1] 0 0
ONKORAS-101
Secondary ID [2] 0 0
TBBO8520-101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-small Cell Lung Cancer 0 0
Metastatic Non-Small Cell Lung Cancer 0 0
NSCLC 0 0
KRAS G12C 0 0
Metastatic Lung Cancer 0 0
Advanced Lung Carcinoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - BBO-8520
Treatment: Drugs - Pembrolizumab

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

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)

Experimental: Cohort 2a - Dose Expansion Monotherapy - Participants enrolled in this cohort will receive BBO-8520 once a day (QD) as monotherapy

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)


Treatment: Drugs: BBO-8520
Participants will receive assigned dose of BBO-8520 orally (PO), QD

Treatment: Drugs: Pembrolizumab
Patients will receive IV pembrolizumab
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Adverse Events
Timepoint [1] 0 0
approximately 3 years
Primary outcome [2] 0 0
Dose-limiting toxicities (DLTs)
Timepoint [2] 0 0
approximately 3 years
Secondary outcome [1] 0 0
To evaluate preliminary antitumor activity of BBO-8520
Timepoint [1] 0 0
approximately 3 years
Secondary outcome [2] 0 0
To evaluate preliminary antitumor activity of BBO-8520
Timepoint [2] 0 0
approximately 3 years
Secondary outcome [3] 0 0
Overall Survival (OS)
Timepoint [3] 0 0
approximately 3 years
Secondary outcome [4] 0 0
To characterize the pharmacokinetics (PK) of BBO-8520
Timepoint [4] 0 0
approximately 3 years
Secondary outcome [5] 0 0
To characterize the pharmacokinetics (PK) of BBO-8520
Timepoint [5] 0 0
approximately 3 years
Secondary outcome [6] 0 0
To characterize the pharmacokinetics (PK) of BBO-8520
Timepoint [6] 0 0
approximately 3 years
Secondary outcome [7] 0 0
To characterize the pharmacokinetics (PK) of BBO-8520
Timepoint [7] 0 0
approximately 3 years

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
22/05/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/02/2028
Actual
Sample size
Target
160
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Peninsula & South Eastern Hematology and Oncology Group (PAS) - Frankston
Recruitment hospital [2] 0 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment postcode(s) [1] 0 0
3199 - Frankston
Recruitment postcode(s) [2] 0 0
3051 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Connecticut
Country [2] 0 0
United States of America
State/province [2] 0 0
Ohio
Country [3] 0 0
United States of America
State/province [3] 0 0
Tennessee
Country [4] 0 0
United States of America
State/province [4] 0 0
Virginia

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
TheRas, Inc., d/b/a BridgeBio Oncology Therapeutics
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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
Trial website
https://clinicaltrials.gov/ct2/show/NCT06343402
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
TheRas
Address 0 0
Country 0 0
Phone 0 0
650-391-9740
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT06343402