Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT06625775 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Open-Label Study of BBO-10203 in Subjects With Advanced Solid Tumors

StatusRecruiting
PhasePhase 1
Started2024-10-29
View on ClinicalTrials.gov ↗

Amendment history

2026-09-02
Study Status, Contacts/Locations v26
Trial sites expanded: 40 → 44 locations
2026-06-18
Study Status, Contacts/Locations v25
Trial sites expanded: 36 → 40 locations
2026-04-06
Study Status, Contacts/Locations v24
Study sites34→36
2026-03-27
Study Status, Contacts/Locations v23
Study sites33→34
2026-03-20
Study Status, Contacts/Locations v22
Study sites32→33
Show 21 earlier versions
2026-03-16
Study Status, Contacts/Locations v21
Study sites31→32
2026-03-02
Study Status, Contacts/Locations v20
Study sites30→31
2026-02-23
Study Status, Contacts/Locations v19
Study sites29→30
2026-02-17
Study Status, Contacts/Locations v18
Study sites27→29
2026-01-23
Study Status, Arms and Interventions, Contacts/Locations v17
Study sites25→27
2025-12-15
Study Status, Contacts/Locations v16
Study sites17→25
2025-11-07
Study Status, Oversight, Contacts/Locations v15
Study sites15→17
2025-08-26
Study Status, Contacts/Locations v14
Study sites13→15
2025-07-28
Study Status, Contacts/Locations v13
Study sites12→13
2025-06-17
Study Identification, Study Status, Study Description, Conditions, Study Design, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v12
Enrollment target153→392
Study sites11→12
Study arms3→5
InterventionsBBO-10203 (Drug), Trastuzumab (Drug)→BBO-10203 (Drug), Bevacizumab (Drug), FOLFOX (Drug), Fulvestrant (Drug), Ribociclib (Drug), Trastuzumab (Drug)
Eligibility criteria+609 characters
[...] atic HER2-positive advanced breast cancer (aBC), HR-positive, /HER2-negative advanced breast cancer, KRAS mutant advanced [...] cell lung cancer (aNSCLC) 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 pr [...] here is no other regionally available standard of care (SoC). PatientsMonotherapy Cohort patien [...] [...]
Secondary endpoints7 to 8 entries
Objective response rate (ORR) as assessed by RECIST v1.1 for patients with measurable disease
Primary endpoints3 entries, revised
Recommended BBO-10203 dose in combination with trastuzumab, fulvestrant +/- ribociclib, and FOLFOX + bevacizumab
Study description+52 characters
[...] d PK of BBO-10203 as a single agent and in combination with trastuzumabTrastuzumab, Fulvestrant +/- Ribociclib, or FOLFOX + Bevacizumab in patients with locally advanced unresectable or metastati [...] ed) solid tumors. The study includes a dose escalation phase, and an expansion phase.
Study title-13 characters
DoseOpen-Label Escalation and ExpansionStudy of BBO-10203 in Subjects With Advanced Solid Tumors (BREAKER-101)
2025-06-03
Study Status, Contacts/Locations v11
Study sites10→11
2025-05-08
Study Status, Contacts/Locations v10
Study sites11→10
2025-05-01
Study Status, Contacts/Locations v9
Study sites10→11
2025-04-11
Study Status, Oversight, Contacts/Locations v8
Study sites7→10
2025-02-25
Study Status, Contacts/Locations v7
Study sites6→7
2025-01-23
Study Status, Contacts/Locations v6
Study sites4→6
2024-12-11
Study Status, Contacts/Locations v5
Study sites3→4
2024-11-08
Study Status, Contacts/Locations v4
Start dateestimated 2024-10→confirmed 2024-10-29
Study sites2→3
2024-10-08
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v3
Trial statusNot Yet Recruiting→Recruiting
Study sitesdetails revised at 2 of 2 sites
2024-10-04
Study Status, Contacts/Locations v2
Study sites0→2
2024-10-02
Study Status, Conditions, Arms and Interventions v1
Re-verified, no change to tracked fields
2024-10-01
Original filing
First in human study to evaluate the safety, tolerability, and pharmacokinetics (PK) of BBO-10203, a PI3Kα:RAS breaker, alone and in combination with other anti-cancer agents in patients with advanced solid tumors.
Trial Details
NCT Number NCT06625775
Lead Sponsor TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics)
Conditions Solid Tumor, Adult, Metastatic Breast Cancer, Advanced Breast Cancer, HER2 Mutation-Related Tumors, HER2-positive Metastatic Breast Cancer, KRAS Mutant Metastatic Colorectal Cancer, Metastatic Lung Cancer, Metastatic Colorectal Cancer +3 more
Enrollment 392 participants
Start Date 2024-10-29
Primary Completion 2028-11 (estimated)
Study Completion 2028-11 (estimated)
Updated on ClinicalTrials.gov 2026-10-01