BBO-11818 in Adult Subjects With KRAS Mutant Cancer
The registry record from ClinicalTrials.gov (public domain): summary, interventions, outcomes and eligibility. Questions are answered only with quotes from this document. Source: ClinicalTrials.gov, retrieved 2026-11-05.
Ongoing
Record metadata
- Phase
- Phase 1
- Status
- Recruiting
- Start
- 2025-03-31
- End
- 2029-09
- Enrollment
- 665
- Sites
- 17
- Sponsor class
- INDUSTRY
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Source text
Brief summary · public domain (ClinicalTrials.gov) · T1
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.
Detailed description · public domain (ClinicalTrials.gov) · T1
This is an open-label, multi-center, Phase 1 study designed to evaluate the safety, tolerability, pharmacokinetics, and efficacy of BBO-11818, a pan-KRAS inhibitor, alone and in combination with pembrolizumab, pembrolizumab + cis/carboplatin + pemetrexed, cetuximab, cetuximab + mFOLFOX6, BBO-10203 + mFOLFOX6, BBO-10203 +cetuximab, mFOLFIRINOX, gemcitabine + nab-paclitaxel, or BBO-10203 in subjects with locally advanced unresectable or metastatic KRAS mutant solid tumors. The study includes a dose escalation phase and a dose expansion phase.
Intervention · public domain (ClinicalTrials.gov) · T1
Drug: BBO-11818. Participants will receive assigned dose of BBO-11818 orally (PO)
Intervention · public domain (ClinicalTrials.gov) · T1
Drug: Pembrolizumab. Patients will receive IV pembrolizumab
Intervention · public domain (ClinicalTrials.gov) · T1
Drug: Platinum chemotherapy (cisplatin or carboplatin). Patients will receive IV platinum chemotherapy (cisplatin or carboplatin)
Intervention · public domain (ClinicalTrials.gov) · T1
Drug: Pemetrexed. Patients will receive IV pemetrexed
Intervention · public domain (ClinicalTrials.gov) · T1
Drug: Cetuximab. Patients will receive IV cetuximab
Intervention · public domain (ClinicalTrials.gov) · T1
Drug: mFOLFOX6. Patients may receive IV mFOLFOX6
Intervention · public domain (ClinicalTrials.gov) · T1
Drug: mFOLFOX6. Patients will receive IV mFOLFOX6
Intervention · public domain (ClinicalTrials.gov) · T1
Drug: BBO-10203. Participants will receive BBO-10203 orally (PO)
Arm · public domain (ClinicalTrials.gov) · T1
Cohort 1a - Dose Escalation Monotherapy (experimental): Participants enrolled in this cohort will receive BBO-11818 as monotherapy
Arm · public domain (ClinicalTrials.gov) · T1
Cohort 1b - Dose Escalation Combination Therapy (Pembrolizumab) (experimental): Participants enrolled in this cohort will receive BBO-11818 in combination with pembrolizumab infusion (IV)
Arm · public domain (ClinicalTrials.gov) · T1
Cohort 1c - Dose Escalation Combination Therapy (Pembrolizumab + Cis/carboplatin + Pemetrexed) (experimental): Participants enrolled in this cohort will receive BBO-11818 in combination with pembrolizumab infusion (IV), cis/carboplatin infusion (IV), and pemetrexed infusion (IV)
Arm · public domain (ClinicalTrials.gov) · T1
Cohort 1d - Dose Escalation Combination Therapy (Cetuximab ± mFOLFOX6) (experimental): Participants enrolled in this cohort will receive BBO-11818 in combination with cetuximab infusion (IV) with or without mFOLFOX6 infusion (IV)
Arm · public domain (ClinicalTrials.gov) · T1
Cohort 1e - Dose Escalation Combination Therapy (BBO-10203 + mFOLFOX6) (experimental): Participants enrolled in this cohort will receive BBO-11818 in combination with BBO-10203 and mFOLFOX6 infusion (IV)
Arm · public domain (ClinicalTrials.gov) · T1
Cohort 1f - Dose Escalation Combination Therapy (BBO-10203 + Cetuximab) (experimental): Participants enrolled in this cohort will receive BBO-11818 in combination with BBO-10203 and cetuximab infusion (IV)
Primary outcome · public domain (ClinicalTrials.gov) · T1
Incidence and severity of treatment emergent adverse events (TEAEs), serious adverse events (SAEs), and dose-limiting toxicities (DLTs). Time frame: approximately 5 years.
Primary outcome · public domain (ClinicalTrials.gov) · T1
Determine 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. Time frame: approximately 5 years.
Secondary outcome · public domain (ClinicalTrials.gov) · T1
Objective response rate (ORR) per RECIST v1.1 and CNS RECIST. Time frame: approximately 5 years.
Secondary outcome · public domain (ClinicalTrials.gov) · T1
Clinical benefit rate (CBR) per RECIST v1.1. Time frame: approximately 5 years.
Secondary outcome · public domain (ClinicalTrials.gov) · T1
Duration of Response (DOR) per RECIST v1.1. Time frame: approximately 5 years.
Secondary outcome · public domain (ClinicalTrials.gov) · T1
Progression-Free Survival (PFS) per RECIST v1.1. Time frame: approximately 5 years.
Secondary outcome · public domain (ClinicalTrials.gov) · T1
Overall Survival (OS). Time frame: approximately 5 years.
Secondary outcome · public domain (ClinicalTrials.gov) · T1
Pharmacokinetics of BBO-11818, BBO-10203, irinotecan, and its metabolites (SN-38 and SN-38-G): Maximum blood concentration (Cmax). Time frame: approximately 5 years.
Eligibility · public domain (ClinicalTrials.gov) · T1
Inclusion Criteria: * Histologically documented locally advanced and unresectable or metastatic NSCLC, PDAC, CRC, or other solid tumor with KRAS G12A, G12C, G12D, G12S, or G12V mutation * Measurable disease by RECIST v1.1 * Eastern Cooperative 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 Other inclusion/exclusion criteria are specified in the protocol.
Enrollment · public domain (ClinicalTrials.gov) · T1
Enrollment: 665 participants (estimated).