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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT06343402
Ethics application status
Date submitted
22/03/2024
Date registered
2/04/2024

Titles & IDs
Public title
Study of BBO-8520 in Adult Subjects with KRASG12C Non-small Cell Lung and Colorectal Cancer
Scientific title
A Phase 1a/1b Open-Label Study of BBO-8520 As Monotherapy and As Part of Combination Therapy in Subjects with Advanced KRASG12C Mutant Non-Small Cell Lung Cancer and Colorectal 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
Colorectal Cancer 0 0
Metastatic Colorectal Cancer 0 0
CRC 0 0
Advanced Colorectal Carcinoma 0 0
Metastatic Colon Cancer 0 0
Colon Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Non melanoma skin cancer
Cancer 0 0 0 0
Kidney
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell
Cancer 0 0 0 0
Bowel - Back passage (rectum) or large bowel (colon)

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 or colorectal 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
229
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Recruitment hospital [1] 0 0
Kinghorn Cancer Centre - Darlinghurst
Recruitment hospital [2] 0 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [3] 0 0
The Queen Elizabeth Hospital - Woodville South
Recruitment hospital [4] 0 0
Peninsula & South Eastern Hematology and Oncology Group (PAS) - Frankston
Recruitment hospital [5] 0 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
5042 - Bedford Park
Recruitment postcode(s) [3] 0 0
5011 - Woodville South
Recruitment postcode(s) [4] 0 0
3199 - Frankston
Recruitment postcode(s) [5] 0 0
3051 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Connecticut
Country [3] 0 0
United States of America
State/province [3] 0 0
Kansas
Country [4] 0 0
United States of America
State/province [4] 0 0
Ohio
Country [5] 0 0
United States of America
State/province [5] 0 0
Tennessee
Country [6] 0 0
United States of America
State/province [6] 0 0
Utah
Country [7] 0 0
United States of America
State/province [7] 0 0
Virginia
Country [8] 0 0
United States of America
State/province [8] 0 0
Washington

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
Trial website
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 d/b/a BridgeBio Oncology Therapeutics
Address 0 0
Country 0 0
Phone 0 0
650-391-9740
Fax 0 0
Email 0 0
onkoras-101ct.gov@bridgebiooncology.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06343402