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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06625775




Registration number
NCT06625775
Ethics application status
Date submitted
1/10/2024
Date registered
3/10/2024

Titles & IDs
Public title
Dose Escalation and Expansion of BBO-10203 in Advanced Solid Tumors (BREAKER-101)
Scientific title
A Phase 1a/1b Study of the PI3Ka:RAS Breaker BBO-10203 in Subjects With Advanced Solid Tumors (The BREAKER-101 Study)
Secondary ID [1] 0 0
TBBO10203-101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Solid Tumor, Adult 0 0
Metastatic Breast Cancer 0 0
Advanced Breast Cancer 0 0
HER2 Mutation-Related Tumors 0 0
HER2-positive Metastatic Breast Cancer 0 0
HER2-Positive Advanced Breast Cancer 0 0
KRAS Mutant Metastatic Colorectal Cancer 0 0
Metastatic Lung Cancer 0 0
Metastatic Colorectal Cancer 0 0
Advanced Lung Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast
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-10203
Treatment: Drugs - Trastuzumab

Experimental: Cohort 1a - Monotherapy Dose Escalation/Cohort Expansion - Participants enrolled in this cohort will receive BBO-10203 tablets orally (different dose levels will be evaluated) once daily (QD) as monotherapy. This cohort will enroll patients with advanced breast cancer, advanced colorectal cancer, and advanced lung cancer.

Experimental: Cohort 1b - BBO-10203 Combination Dose Expansion - Participants enrolled in this cohort will receive BBO-10203 tablets orally QD in combination with trastuzumab IV (8mg/kg over 90 minutes on Cycle 1 Day 1, 6mg/kg over 30-90 minutes during subsequent cycles)/SC (600mg). This cohort will enroll patients with advanced breast cancer.

Experimental: Combination Dose Escalation - Participants enrolled in this cohort will receive BBO-10203 tablets orally (different dose levels will be evaluated) QD in combination with trastuzumab IV (8mg/kg over 90 minutes on Cycle 1 Day 1, 6mg/kg over 30-90 minutes during subsequent cycles)/SC (600mg). This cohort will enroll patients with advanced breast cancer.


Treatment: Drugs: BBO-10203
Participants will receive assigned dose of BBO-10203 orally (PO) QD

Treatment: Drugs: Trastuzumab
Participants will receive trastuzumab infusion (IV) or subcutaneous (SC)
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Determination of maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of BBO-10203 as a single agent
Timepoint [1] 0 0
Up to approximately 5 years
Primary outcome [2] 0 0
Percentage of patients with treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and dose-limiting toxicities (DLTs)
Timepoint [2] 0 0
Up to approximately 5 years
Primary outcome [3] 0 0
Recommended BBO-10203 dose in combination with trastuzumab
Timepoint [3] 0 0
Up to approximately 5 years
Secondary outcome [1] 0 0
Clinical benefit rate (CBR) as assessed by RECIST v1.1.
Timepoint [1] 0 0
Up to approximately 5 years
Secondary outcome [2] 0 0
Duration of response (DOR) as assessed by RECIST v1.1.
Timepoint [2] 0 0
Up to approximately 5 years
Secondary outcome [3] 0 0
Progression-free survival (PFS) as assessed by RECIST v1.1
Timepoint [3] 0 0
Up to approximately 5 years
Secondary outcome [4] 0 0
Overall survival (OS)
Timepoint [4] 0 0
Up to approximately 5 years
Secondary outcome [5] 0 0
Area under the concentration-time curve (AUC
Timepoint [5] 0 0
Predose (within 30 minutes) of C1D1 until up to approximately 5 years
Secondary outcome [6] 0 0
Maximum plasma drug concentration (Cmax)
Timepoint [6] 0 0
Predose (within 30 minutes) of C1D1 until up to approximately 5 years
Secondary outcome [7] 0 0
Time for maximum plasma drug concentration (Tmax)
Timepoint [7] 0 0
Predose (within 30 minutes) of C1D1 until up to approximately 5 years

Eligibility
Key inclusion criteria
* Locally advanced and unresectable or metastatic HER2-positive advanced breast cancer (aBC), HR-positive, / HER2-negative advanced breast cancer, KRAS mutant advanced colorectal cancer (aCRC), or KRAS mutant advanced non-small cell lung cancer (aNSCLC)
* Measurable disease by RECIST v1.1
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1
* Adequate LVEF assessed by ECHO or MUGA
* Patients with HER2-positive aBC: Must have had at least 2 prior lines of anti-HER2-directed therapy. Only 1 prior line is acceptable where there is no other regionally available standard of care (SoC).
* Patients with HR-positive, HER2-negative aBC, KRAS mutant aCRC or aNSCLC: Must have progression on, or disease recurrence after, all available SoC treatments or in the opinion of the investigator, would be unlikely to tolerate or derive clinically meaningful benefit from appropriate SoC therapy.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Patients with HER2+ aBC who have had more than 1 prior line of therapy with an antibody-drug conjugate
* Patients with KRAS mutant aCRC who have BRAFV600E mutation, HER2amp, or dMMR/MSI-H tumors
* Patients with KRAS mutant aNSCLC who have tumors with other targetable driver mutations (eg, EGFR, anaplastic lymphoma kinase, ROS1/BRAF/RET/MET/EGFR exon20 insertion/NTRK/HER2)
* Patients with untreated brain metastases (exceptions apply for HER2+ aBC per protocol)

Other inclusion/exclusion criteria are specified in the protocol

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
29/10/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/11/2028
Actual
Sample size
Target
153
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment postcode(s) [1] 0 0
3000 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Massachusetts
Country [2] 0 0
United States of America
State/province [2] 0 0
Tennessee
Country [3] 0 0
United States of America
State/province [3] 0 0
Texas

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
BridgeBio Oncology Therapeutics
Address 0 0
Country 0 0
Phone 0 0
650-391-9740
Fax 0 0
Email 0 0
Breaker-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)?
Yes
What data in particular will be shared?
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


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/NCT06625775