Open-Label Study of BBO-10203 in Subjects With Advanced Solid Tumors
NCT ID: NCT06625775
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
392 participants
INTERVENTIONAL
2024-10-29
2028-11-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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BBO-10203
Participants enrolled in this cohort will receive BBO-10203 tablets orally (different dose levels will be evaluated) once daily as monotherapy. This cohort will enroll patients with HER2-positive advanced breast cancer, HR-positive HER2-negative advanced breast cancer, advanced colorectal cancer, and advanced lung cancer.
BBO-10203
Participants will receive assigned dose of BBO-10203 orally once daily
BBO-10203 + Trastuzumab
Participants enrolled in this cohort will receive BBO-10203 tablets orally in combination with trastuzumab (8mg/kg infusion over 90 minutes on Cycle 1 Day 1, 6mg/kg infusion over 30-90 minutes during subsequent cycles or 600mg subcutaneous). This cohort will enroll patients with HER2-positive advanced breast cancer.
BBO-10203
Participants will receive assigned dose of BBO-10203 orally once daily
Trastuzumab
Participants will receive trastuzumab as infusion or subcutaneous injection every 21 days
BBO-10203 + Fulvestrant
Participants enrolled in this cohort will receive BBO-10203 tablets orally in combination with fulvestrant (500mg IM). This cohort will enroll patients with HR-positive, HER2-negative advanced breast cancer.
BBO-10203
Participants will receive assigned dose of BBO-10203 orally once daily
Fulvestrant
Patients will receive Fulvestrant as an intramuscular injection every 28 days (additional dose on C1D15)
Ribociclib
Patients will receive Ribociclib orally once a day (21 days on treatment, 7 days off)
BBO10203 + Fulvestrant + Ribociclib
Participants enrolled in this cohort will receive BBO-10203 tablets orally in combination with fulvestrant (500mg IM) and ribociclib (600mg orally) as determined in the dose escalation. This cohort will enroll patients with HR-positive, HER2-negative advanced breast cancer.
BBO-10203
Participants will receive assigned dose of BBO-10203 orally once daily
Fulvestrant
Patients will receive Fulvestrant as an intramuscular injection every 28 days (additional dose on C1D15)
Ribociclib
Patients will receive Ribociclib orally once a day (21 days on treatment, 7 days off)
BBO10203 + FOLFOX + Bevacizumab
Participants enrolled in this cohort will receive BBO-10203 tablets orally in combination with FOLFOX (oxaliplatin 85 mg/m2, leucovorin 400 mg/m2, 5FU 400 mg/m2 + 2400 mg/m2) and bevacizumab (5 mg/kg IV). This cohort will enroll patients with KRAS-mutant advanced colorectal cancer.
BBO-10203
Participants will receive assigned dose of BBO-10203 orally once daily
FOLFOX
Patients will receive FOLFOX as infusion every 14 days
Bevacizumab
Patients will receive bevacizumab as infusion every 28 days
Interventions
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BBO-10203
Participants will receive assigned dose of BBO-10203 orally once daily
Trastuzumab
Participants will receive trastuzumab as infusion or subcutaneous injection every 21 days
Fulvestrant
Patients will receive Fulvestrant as an intramuscular injection every 28 days (additional dose on C1D15)
Ribociclib
Patients will receive Ribociclib orally once a day (21 days on treatment, 7 days off)
FOLFOX
Patients will receive FOLFOX as infusion every 14 days
Bevacizumab
Patients will receive bevacizumab as infusion every 28 days
Eligibility Criteria
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Inclusion Criteria
* Measurable disease by RECIST v1.1 (except for HR-positive HER2-negative aBC where evaluable bone-only disease is permitted)
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1
* Adequate LVEF assessed by ECHO or MUGA (BBO-10203 + Trastuzumab cohorts only)
* Stable brain metastases
* 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)
* Monotherapy Cohort patients with HR-positive, HER2-negative aBC, KRAS mutant aCRC or aNSCLC: Must have progression on, or disease recurrence after at least one line of SOC treatment or in the opinion of the investigator, would be unlikely to tolerate or derive clinically meaningful benefit from SoC therapy
* BBO-10203 + Fulvestrant combination cohort patients with HR-positive, HER2-negative aBC: confirmed PIK3CA mutation, must have been treated with a CDK4/6i
* BBO-10203 + Fulvestrant + ribociclib combination cohort patients with HR-positive, HER2-negative aBC: confirmed PIK3CA mutation, no prior systemic therapy in the aBC setting permitted
* BBO-10203 + FOLFOX + Bevacizumab combination cohort patients with KRAS mutant aCRC: One prior line of irinotecan-containing therapy for locally advanced or metastatic CRC is allowed but not required
Exclusion Criteria
* Patients with KRAS mutant aNSCLC who have KRAS G12R mutation, or tumors with other targetable driver mutations (eg, EGFR, anaplastic lymphoma kinase, ROS1/BRAF/RET/MET/EGFR exon20 insertion/NTRK/HER2)
* Patients with untreated and/or non-stable brain metastases
18 Years
ALL
No
Sponsors
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TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics)
INDUSTRY
Responsible Party
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Locations
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University of California Los Angeles
Los Angeles, California, United States
University of California San Diego Moores Cancer Center
San Diego, California, United States
Moffitt Cancer Center
Tampa, Florida, United States
Indiana University Simon Comprehensive Cancer Center
Indianapolis, Indiana, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Dana-Farber Cancer Insitute
Boston, Massachusetts, United States
Columbia University Irving Medical Center
New York, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
SCRI Oncology Partners
Nashville, Tennessee, United States
SCRI at Mary Crowley
Dallas, Texas, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States
University of Texas San Antonio (UTSA)
San Antonio, Texas, United States
Fred Hutchinson Cancer Center
Seattle, Washington, United States
Scientia Clinical Research
Randwick, New South Wales, Australia
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia
Hospital Universitario Fundación Jiménez Díaz
Madrid, , Spain
Countries
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Central Contacts
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Other Identifiers
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2024-519445-29-00
Identifier Type: CTIS
Identifier Source: secondary_id
BREAKER-101
Identifier Type: OTHER
Identifier Source: secondary_id
TBBO10203-101
Identifier Type: -
Identifier Source: org_study_id