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BBO-11818 in Adult Subjects With KRAS Mutant Cancer

StatusRecruiting
PhasePhase 1
Started2025-03-31
View on ClinicalTrials.gov ↗

Amendment history

2026-05-29
Study Status, Study Description, Conditions, Study Design, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v11
Primary endpoint(s) modified2 entries, revised
WasDetermine recommended dose of BBO-11818 in combination with pembrolizumab +/- cis/carboplatin + pemetrexed, or cetuximab +/- FOLFOX, NALIRIFOX, or Gemcitabine + Nab-paclitaxel, Incidence and severity of treatment emergent adverse events (TEAEs), serious adverse events (SAEs), and dose-limiting toxicities (DLTs)
NowDetermine recommended dose of BBO-11818 in combination with pembrolizumab ± cis/carboplatin + pemetrexed, cetuximab ± mFOLFOX6, BBO-10203 + mFOLFOX6, BBO-10203 + cetuximab, cetuximab, mFOLFIRINOX, gemcitabine + nab-paclitaxel, or BBO-10203, Incidence and severity of treatment emergent adverse events (TEAEs), serious adverse events (SAEs), and dose-limiting toxicities (DLTs)
Enrollment increased: 387 → 665 participants
Trial arms changed: 14 → 20
Trial sites expanded: 11 → 17 locations
InterventionsBBO-11818 (Drug), Cetuximab (Drug), FOLFOX (Drug), Gemcitabine (Drug), NALIRIFOX (Drug), Nab-paclitaxel (Drug), Pembrolizumab (Drug)…→BBO-10203 (Drug), BBO-11818 (Drug), Cetuximab (Drug), Gemcitabine (Drug), Nab-paclitaxel (Drug), Pembrolizumab (Drug), Pemetrexed (Drug)…
Eligibility criteria-4 characters
[...] operative Oncology Group (ECOG) performance status (PS) 0-1 Life expectancy >24 weeks Adequate organ function Exclusion Criteria: Malignancy within the last 2 years as specified in the protocol Untreated brain metastases Known hypersensitivity to BBO-11818 or its excipients Other inclusion/exclusion criteria are specified in the protocol.
Secondary endpoints8 entries, revised
Pharmacokinetics of BBO-11818, BBO-10203, irinotecan, and its metabolites (SN-38 and SN-38-G): Maximum blood concentration (Cmax) Pharmacokinetics of BBO-11818, BBO-10203, irinotecan, and its metabolites (SN-38 and SN-38-G): Time to achieve Cmaxmaximum concentration (Tmax) Pharmacokinetics of BBO-11818, BBO-10203, irinotecan, and its metabolites (SN-38 and SN-38-G): Area under the concentration-time curve (AUC)
Study description+70 characters
[...] alone and in combination with pembrolizumab, pembrolizumab +/- cis/carboplatin + pemetrexed, cetuximab, cetuximab +/- FOLFOXmFOLFOX6, NALIRIFOXBBO-10203 + mFOLFOX6, BBO-10203 +cetuximab, mFOLFIRINOX, gemcitabine + nab-paclitaxel, or Gemcitabine + NabBBO-paclitaxel10203 in subjects with locally advanced unresectable or metastatic KRAS mutant solid tumors. The study includes a dose escalation phase and a dose expansion phase.
2026-03-20
Study Status, Contacts/Locations v10
Study sites10→11
2026-03-16
Study Status, Contacts/Locations v9
Study sites9→10
2026-02-09
Study Status, Contacts/Locations v8
Study sitescontacts updated at 9 of 9 sites
2026-01-16
Study Status, Study Description, Conditions, Study Design, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v7
Enrollment target287→387
Study sites8→9
Study arms8→14
InterventionsBBO-11818 (Drug), Cetuximab (Drug), Pembrolizumab (Drug), Pemetrexed (Drug), Platinum chemotherapy (cisplatin or carboplatin) (Drug)→BBO-11818 (Drug), Cetuximab (Drug), FOLFOX (Drug), Gemcitabine (Drug), NALIRIFOX (Drug), Nab-paclitaxel (Drug), Pembrolizumab (Drug)…
Eligibility criteria-23 characters
[...] lid tumor with KRAS G12A, G12C, G12D, G12S, or G12V mutation, or KRAS-amplification Measurable disease by RECIST v1.1 Eastern Cooperative Oncol [...]
Secondary endpoints8 entries, revised
Pharmacokinetics of BBO-11818, irinotecan, and SN-38: Maximum blood concentration (Cmax) Pharmacokinetics of BBO-11818, irinotecan, and SN-38: Time to achieve Cmax (Tmax) Pharmacokinetics of BBO-11818, irinotecan, and SN-38: Area under the concentration-time curve (AUC)
Primary endpoints2 entries, revised
Determine recommended dose of BBO-11818 in combination with pembrolizumab +/- cis/carboplatin + pemetrexed, or cetuximab +/- FOLFOX, NALIRIFOX, or Gemcitabine + Nab-paclitaxel
Study description+52 characters
[...] brolizumab, pembrolizumab +/- cis/carboplatin + pemetrexed, cetuximab +/- FOLFOX, NALIRIFOX, or cetuximabGemcitabine + Nab-paclitaxel in subjects with locally advanced unresectable or metastati [...]
Show 6 earlier versions
2025-12-11
Study Status, Oversight, Contacts/Locations v6
Re-verified, no change to tracked fields
2025-09-12
Study Status, Contacts/Locations v5
Study sites6→8
2025-08-01
Study Status, Contacts/Locations v4
Study sites4→6
2025-06-03
Study Identification, Study Status, Conditions, Contacts/Locations v3
Re-verified, no change to tracked fields
2025-04-30
Study Status, Contacts/Locations v2
Study sites1→4
2025-04-08
Study Identification, Study Status, Oversight v1
Study title-20 characters
Open-label Study of BBO-11818 in Adult Subjects With KRAS Mutant Cancer
2025-04-01
Original filing
A first in human study to evaluate the safety and preliminary antitumor activity of BBO-11818, a pan-KRAS inhibitor, in subjects with locally advanced unresectable or metastatic KRAS mutant solid tumors.
Trial Details
NCT Number NCT06917079
Lead Sponsor TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics)
Conditions Non-Small Cell Lung Cancer, NSCLC, PDAC - Pancreatic Ductal Adenocarcinoma, CRC (Colorectal Cancer), Metastatic Non-Small Lung Cell Cancer, Metastatic Colorectal Cancer (CRC), KRAS G12A, KRAS G12C +6 more
Enrollment 665 participants
Start Date 2025-03-31
Primary Completion 2027-08 (estimated)
Study Completion 2029-09 (estimated)
Updated on ClinicalTrials.gov 2026-06-02