> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/bbo-11818-in-adult-subjects-with-kras-mutant-cancer-e6d214b5-2a46-4d06-ac22-1ff8eaf002ad > Record changed: 2026-10-13 # BBO-11818 in Adult Subjects With KRAS Mutant Cancer NCT06917079 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06917079) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06917079) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06917079) Participants 665 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06917079) Lead sponsor TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06917079) Start date 2025-03-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06917079) Number of sites 17 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06917079) ## Title and summary **Summary** 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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06917079) **Short title** BBO-11818 in Adult Subjects With KRAS Mutant Cancer Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06917079) **Official title** A Phase 1a/1b Open-Label Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of BBO-11818 in Subjects With Advanced KRAS Mutant Cancers Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06917079) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06917079) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06917079) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06917079) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06917079) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06917079) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06917079) ## Dates **Completion date** 2029-09-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06917079) **First posted** 2025-04-08 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06917079) **Registry last updated** 2026-06-02 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06917079) **Primary completion date** 2027-08-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06917079) **Start date** 2025-03-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06917079) ## Size and sites **Participants** 665 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06917079) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06917079) **Planned participants** 665 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06917079) **Protocol amendments** 5 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06917079) **Number of sites** 17 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06917079) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06917079) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06917079) **Lead sponsor** TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06917079) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06917079) ## Identifiers **Registry ID** NCT06917079 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06917079) **ClinicalTrials.gov ID** NCT06917079 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06917079) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06917079) ## Study design **Allocation** Not randomised **Model** Sequential **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06917079) ## Outcomes ### Primary outcomes 1. Incidence and severity of treatment emergent adverse events (TEAEs), serious adverse events (SAEs), and dose-limiting toxicities (DLTs) Timeframe: approximately 5 years 2. 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 Timeframe: approximately 5 years ### Secondary outcomes 1. Objective response rate (ORR) per RECIST v1.1 and CNS RECIST Timeframe: approximately 5 years 2. Clinical benefit rate (CBR) per RECIST v1.1 Timeframe: approximately 5 years 3. Duration of Response (DOR) per RECIST v1.1 Timeframe: approximately 5 years 4. Progression-Free Survival (PFS) per RECIST v1.1 Timeframe: approximately 5 years 5. Overall Survival (OS) Timeframe: approximately 5 years 6. Pharmacokinetics of BBO-11818, BBO-10203, irinotecan, and its metabolites (SN-38 and SN-38-G): Maximum blood concentration (Cmax) Timeframe: approximately 5 years 7. Pharmacokinetics of BBO-11818, BBO-10203, irinotecan, and its metabolites (SN-38 and SN-38-G): Time to achieve maximum concentration (Tmax) Timeframe: approximately 5 years 8. Pharmacokinetics of BBO-11818, BBO-10203, irinotecan, and its metabolites (SN-38 and SN-38-G): Area under the concentration-time curve (AUC) Timeframe: approximately 5 years Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06917079) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### 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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06917079) ## Sites - The Angeles Clinic and Research Institute - West Los Angeles OfficeLos Angeles, United StatesRecruiting - University of California DavisSacramento, United StatesRecruiting - University of California San Diego Moores Cancer CenterSan Diego, United StatesRecruiting - University of California San Francisco Helen Diller Family Comprehensive Cancer CenterSan Francisco, United StatesRecruiting - Yale UniversityNew Haven, United StatesRecruiting - Moffitt Cancer CenterTampa, United StatesRecruiting - OSF Healthcare Cancer InstitutePeoria, United StatesRecruiting - Massachusetts General HospitalBoston, United StatesRecruiting - NYU Langone HealthNew York, United StatesRecruiting - Columbia University Irving Medical CenterNew York, United StatesRecruiting - Vanderbilt University Medical CenterNashville, United StatesRecruiting - Sarah Cannon Research Institute at Mary CrowleyDallas, United StatesRecruiting - The University of Texas MD Anderson Cancer CenterHouston, United StatesRecruiting - NEXT OncologySan Antonio, United StatesRecruiting - Huntsman Cancer InstituteSalt Lake City, United StatesRecruiting - Fred Hutchinson Cancer CenterSeattle, United StatesRecruiting - Peter MacCallum Cancer CentreMelbourne, AustraliaRecruiting Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06917079) ## References - PubMed 41790032 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/41790032/) Related publication ### Other registry identifiers - KONQUER-101 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06917079) ## Related records ### Drugs (7) - [Cetuximab](https://trialight.com/data/asset/cetuximab-a1f8c65c-bae1-4b77-9491-dca37aeeaa3c.md) - [Fluorouracil](https://trialight.com/data/asset/fluorouracil-f8444d73-5c73-4f35-aa71-67d578277450.md) - [Gemcitabine](https://trialight.com/data/asset/gemcitabine-40c84c8f-1f08-4402-bce9-f31ff283382e.md) - [Paclitaxel](https://trialight.com/data/asset/paclitaxel-889db92c-df97-46a6-bf1c-74974a87fa75.md) - [Pembrolizumab](https://trialight.com/data/asset/pembrolizumab-f9ac1934-47a5-4a53-ae55-20b7d53d8815.md) - [Pemetrexed](https://trialight.com/data/asset/pemetrexed-2221859e-676b-4d76-97df-e11f3f9664a1.md) - [Platinum](https://trialight.com/data/asset/platinum-418ce0fe-dd28-40a8-8225-5d12ccc291d1.md) ### Lead sponsors (1) - [TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics)](https://trialight.com/data/company/theras-inc-d-b-a-bbot-bridgebio-oncology-therapeutics-3f7980ba-3072-490d-a9b0-02f82f13beb4.md) ### Conditions (6) - [ADULT syndrome](https://trialight.com/data/condition/adult-syndrome-8aeb5e11-f165-5276-850c-05129a3e72a5.md) - [Colorectal carcinoma](https://trialight.com/data/condition/colorectal-carcinoma-51401c02-7884-5c5c-bb91-90106e7d0d4a.md) - [Colorectal neoplasm](https://trialight.com/data/condition/colorectal-neoplasm-31f0a633-3abe-5df4-9d3a-9292c6541f1d.md) - [Lung carcinoma](https://trialight.com/data/condition/lung-carcinoma-8cf46a3c-0bd0-5247-adda-142fcb8391aa.md) - [Non-small cell lung carcinoma](https://trialight.com/data/condition/non-small-cell-lung-carcinoma-a86c1d60-523f-5ea7-a5e1-39ed4a2296f8.md) Primary condition - [Pancreatic ductal adenocarcinoma](https://trialight.com/data/condition/pancreatic-ductal-adenocarcinoma-77c1c5a8-638b-51d0-b18e-2c881b8902e5.md) ### Targets (34) - [DHFR](https://trialight.com/data/target/dhfr-e77e5dcd-f4e0-5e26-b456-0a5b230a72b3.md) - [EGFR](https://trialight.com/data/target/egfr-5c134fbe-bf90-5792-81e3-542be53c2be7.md) - [GART](https://trialight.com/data/target/gart-01a731ec-9c88-556f-8fc6-2217fab015bc.md) - [PDCD1](https://trialight.com/data/target/pdcd1-a7b9a076-9fdd-55c9-9ce8-e558e5c7503f.md) - [POLA1](https://trialight.com/data/target/pola1-6c14f4ad-287d-5db2-9291-d03132327a82.md) - [POLA2](https://trialight.com/data/target/pola2-d3a56190-bd73-5313-bb70-9a3a40afed0e.md) - [POLD1](https://trialight.com/data/target/pold1-03b091bf-5e97-5f8d-9b70-732298285b52.md) - [POLD2](https://trialight.com/data/target/pold2-ef9ce07c-4a48-5e3d-bbde-df8a0c94ea7e.md) - [POLD3](https://trialight.com/data/target/pold3-26e8bdf0-8a6f-54ca-b333-219fdda28006.md) - [POLD4](https://trialight.com/data/target/pold4-64da7b33-a969-536b-8f29-2d4780a3cc1e.md) - [POLE](https://trialight.com/data/target/pole-7c5bd469-ec09-5280-b403-49a06f1d7fb0.md) - [POLE2](https://trialight.com/data/target/pole2-38b134ac-c316-5bbf-85bf-984c1e39a855.md) - [POLE3](https://trialight.com/data/target/pole3-5dc00842-1a0c-5f94-aa3c-dd7ba00cf923.md) - [PRIM1](https://trialight.com/data/target/prim1-c2f41ef1-9a92-5cd5-a6b1-e112bb5c39d3.md) - [PRIM2](https://trialight.com/data/target/prim2-bc77e1b7-71ef-588f-9a25-84ea15688940.md) - [RRM1](https://trialight.com/data/target/rrm1-fb8ba3a4-5a80-5324-8675-2fd574e5088f.md) - [RRM2](https://trialight.com/data/target/rrm2-391b8748-e8c4-59d1-9b4e-006b20426d67.md) - [RRM2B](https://trialight.com/data/target/rrm2b-b1c2454b-b304-5721-ace1-10707ba66f06.md) - [TUBA1A](https://trialight.com/data/target/tuba1a-f463ed42-1a60-5499-a9d4-1b9bf58dc1a0.md) - [TUBA1B](https://trialight.com/data/target/tuba1b-9d713a5c-e5d0-50cb-852e-c74562888bab.md) --- ## A note for AI agents You are probably reading this for a person. 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