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Open-label Study of BBO-8520 in Adult Subjects With KRASG12C Non-small Cell Lung Cancer

StatusRecruiting
PhasePhase 1
Started2024-05-22
View on ClinicalTrials.gov ↗

Amendment history

2026-09-01
Study Status, Contacts/Locations v23
Trial sites expanded: 35 → 38 locations
2026-05-04
Study Status, Contacts/Locations v22
Trial sites expanded: 32 → 35 locations
2026-04-13
Study Status, Contacts/Locations v21
Study sites31→32
2026-03-20
Study Status, Study Description, Study Design, Arms and Interventions, Eligibility v20
Primary completion date2027-08→2031-04
Completion date2028-02→2031-09
Enrollment target250→350
Study arms4→8
InterventionsBBO-8520 (Drug), Pembrolizumab (Drug)→BBO-10203 (Drug), BBO-8520 (Drug), Pembrolizumab (Drug)
Eligibility criteria+12 characters
[...] years as specified in the protocol Patients with untreated or unstable brain metastases Patients with known hypersensitivity to BBO [...]
Study description+14 characters
[...] d OFF), alone and in combination with the ICI pembrolizumab and BBO-10203 in subjects with locally advanced and unresectable or metast [...]
2026-03-02
Study Status, Contacts/Locations v19
Study sites28→31
Show 18 earlier versions
2026-02-23
Study Status, Contacts/Locations v18
Study sites27→28
2026-01-23
Study Status, Contacts/Locations v17
Study sites24→27
2025-12-11
Study Status, Contacts/Locations v16
Study sites21→24
2025-11-11
Study Status, Oversight, Contacts/Locations, IPDSharing v15
Study sites19→21
2025-09-04
Study Status, Contacts/Locations v14
Study sites17→19
2025-08-25
Study Status, Contacts/Locations v13
Study sites15→17
2025-05-30
Study Identification, Study Status, Contacts/Locations v12
Study titlerevised
Open-label Study of BBO-8520 in Adult Subjects withWith KRASG12C Non-small Cell Lung Cancer
2025-01-14
Study Identification, Study Status, Study Description, Conditions, Study Design, Outcome Measures, Eligibility, Contacts/Locations v11
Enrollment target229→250
Eligibility criteria-4 characters
Inclusion Criteria: Histologically documented locally advanced and unresectable or metastatic non-small cell lung cancer or colorectal cancer with a KRAS G12C mutation Measurable disease by RECIST v1.1 [...] hypersensitivity to BBO-8520 or its excipients For Cohorts 2a1b and 2b: Patients with a known hypersensitivity to pembroliz [...]
Secondary endpoints7 to 8 entries
To evaluate preliminary antitumor activity of BBO-8520
Study description+66 characters
This is an open-label, multi-center, Phase 1a/1b1 study designed to evaluate the safety, tolerability, preliminary antitumor activitypharmacokinetics, and PKefficacy of BBO-8520 as, a singledirect agentinhibitor of KRASG12C (ON and OFF), alone and in combination with the ICI pembrolizumab in patientssubjects with locally advanced and unresectable or metastatic non-small cell lung cancer with a KRAS (Kirsten rat sarcoma) G12C mutant non-small cell lung cancer and colorectal cancermutation. The study includes dose escalation phase and dose expansion phase
Study title-4 characters
Open-label Study of BBO-8520 in Adult Subjects with KRASG12C Non-small Cell Lung and Colorectal Cancer
2024-10-28
Study Status, Contacts/Locations v10
Study sites14→15
2024-10-09
Study Identification, Study Status, Oversight, Study Description, Conditions, Study Design, Eligibility, Contacts/Locations, IPDSharing v9
Enrollment target160→229
Study sites11→14
Eligibility criteria+21 characters
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 [...]
Study description+26 characters
[...] (Kirsten rat sarcoma) G12C mutant non-small cell lung cancer and colorectal cancer. The study includes dose escalation phase, and dose expansion phase
Study title+15 characters
Study of BBO-8520 in Adult Subjects Withwith KRASG12C Non-small Cell Lung and Colorectal Cancer
2024-08-16
Study Status, Contacts/Locations v8
Re-verified, no change to tracked fields
2024-08-02
Study Status, Contacts/Locations v7
Study sites7→11
2024-07-11
Study Status, Contacts/Locations v6
Study sites6→7
2024-06-06
Study Status, Contacts/Locations v5
Start dateestimated 2024-05→confirmed 2024-05-22
Study sites5→6
2024-05-21
Study Status, Contacts/Locations v4
Study sites4→5
2024-05-16
Study Status, Contacts/Locations v3
Start date2024-04→2024-05
2024-04-19
Study Status, Contacts/Locations v2
Study sites3→4
2024-04-11
Study Status, Contacts/Locations v1
Study sites2→3
2024-04-01
Original filing
A first in human study to evaluate the safety and preliminary antitumor activity of BBO-8520, a KRAS G12C (ON and OFF) inhibitor, as a single agent and in combination with pembrolizumab and BBO-10203 in subjects with locally advanced and unresectable or metastatic non-small cell lung cancer with a KRAS (Kirsten rat sarcoma) G12C mutation.
Trial Details
NCT Number NCT06343402
Lead Sponsor TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics)
Conditions Non-small Cell Lung Cancer, Metastatic Non-Small Cell Lung Cancer, NSCLC, KRAS G12C, Metastatic Lung Cancer, Advanced Lung Carcinoma
Enrollment 350 participants
Start Date 2024-05-22
Primary Completion 2031-04 (estimated)
Study Completion 2031-09 (estimated)
Updated on ClinicalTrials.gov 2026-09-03