Clinical trial · Interventional
BBO-11818 in Adult Subjects With KRAS Mutant Cancer
A Phase 1a/1b Open-Label Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of BBO-11818 in Subjects With Advanced KRAS Mutant Cancers
NCT06917079CI-TRIAL-00113360recruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (14)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Lung Carcinoma | Lung Carcinoma | CURATED_BROADER | 0.78 |
| CRC (Colorectal Cancer) | Colorectal Carcinoma | ALIAS | 0.85 |
| KRAS G12A | — | UNRESOLVED | — |
| KRAS G12C | — | UNRESOLVED | — |
| KRAS G12D | — | UNRESOLVED | — |
| KRAS G12S | — | UNRESOLVED | — |
| KRAS G12V | — | UNRESOLVED | — |
| Metastatic Colorectal Cancer (CRC) | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Metastatic Non-Small Lung Cell Cancer | — | UNRESOLVED | — |
| Metastatic Pancreatic Ductal Adenocarcinoma | Pancreatic Ductal Adenocarcinoma | CURATED_BROADER |
Interventions
Interventions (10)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BBO-10203 | Drug | — | UNRESOLVED |
| BBO-11818 | Drug | — | UNRESOLVED |
| Cetuximab | Drug | Cetuximab | ALIAS |
| Gemcitabine | Drug | Gemcitabine | ALIAS |
| mFOLFIRINOX | Drug | — | UNRESOLVED |
| mFOLFOX6 | Drug | — | UNRESOLVED |
| Nab-paclitaxel | Drug | Nab-paclitaxel | ALIAS |
| Pembrolizumab | Drug | Pembrolizumab | ALIAS |
| Pemetrexed | Drug | Pemetrexed |
Design
Arms and outcomes
Arms (20)
- type
- EXPERIMENTAL
- label
- Cohort 1a - Dose Escalation Monotherapy
- description
- Participants enrolled in this cohort will receive BBO-11818 as monotherapy
- interventionNames
- Drug: BBO-11818
- type
- EXPERIMENTAL
- label
- Cohort 1b - Dose Escalation Combination Therapy (Pembrolizumab)
- description
- Participants enrolled in this cohort will receive BBO-11818 in combination with pembrolizumab infusion (IV)
- interventionNames
- Drug: BBO-11818
- Drug: Pembrolizumab
- type
- EXPERIMENTAL
- label
- Cohort 1c - Dose Escalation Combination Therapy (Pembrolizumab + Cis/carboplatin + Pemetrexed)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDStahlhut C, Maciag AE, Sullivan KA, Singh K, Gitego N, Zhang Z, Chan AH, Sharma AK, Alexander PA, Shu J, Yang Y, Rigby M, Ma R, Setoodeh S, Smith BP, Pei J, Rabara D, Larsen EK, Turner DM, Zhang C, Feng C, Feng S, Stice JP, Xu R, Lin K, Stephen AG, Lightstone FC, Ji C, Wang K, Simanshu DK, Nissley DV, Wallace E, Wang B, Sinkevicius KW, McCormick F, Beltran PJ. Discovery of BBO-11818, a Potent and Selective Noncovalent Inhibitor of (ON) and (OFF) KRAS with Activity against Multiple Oncogenic Mutants. Cancer Discov. 2026 Apr 1;16(4):740-759. doi: 10.1158/2159-8290.CD-25-1280. PMID 41790032