Non-Small Cell Lung CancerPhase 1NCT06917079
BBO-11818 in Adult Subjects With KRAS Mutant Cancer
A Phase 1 study testing BBO-11818, Pembrolizumab and Platinum chemotherapy (cisplatin or carboplatin) in people with Non-Small Cell Lung Cancer and NSCLC, run by TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics) at 17 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small Cell Lung Cancer, NSCLC, PDAC - Pancreatic Ductal Adenocarcinoma
- What is being tested?
- BBO-11818, Pembrolizumab and Platinum chemotherapy (cisplatin or carboplatin)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 665 participants
- Where
- 17 sitesin 2 countries
- Study dates
- 31 Mar 2025to Sep 2029
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Malignancy within the last 2 years as specified in the protocol
- Untreated brain metastases
- Other inclusion/exclusion criteria are specified in the protocol.
Trial locations and contacts
17 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics) contact
17 sites in 2 countries
United States16 sites, 16 recruiting
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
617-724-4000
- Recruiting
Sarah Cannon Research Institute at Mary Crowley
Dallas, Texas, 75230
972-566-3000
- Recruiting
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
877-632-6789
- Recruiting
The Angeles Clinic and Research Institute - West Los Angeles Office
Los Angeles, California, 90025
310-582-7900
- Recruiting
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
615-936-8422
- Recruiting
Yale University
New Haven, Connecticut, 06510
203-200-2486
- Recruiting
NYU Langone Health
New York, New York, 10016
646-929-7870
- Recruiting
Columbia University Irving Medical Center
New York, New York, 10032
877-426-5637
- Recruiting
OSF Healthcare Cancer Institute
Peoria, Illinois, 61637
309-308-3800
- Recruiting
University of California Davis
Sacramento, California, 95817
916-734-5959
- Recruiting
Huntsman Cancer Institute
Salt Lake City, Utah, 84112
801-587-7000
- Recruiting
NEXT Oncology
San Antonio, Texas, 78229
210-580-9500
- Recruiting
University of California San Diego Moores Cancer Center
San Diego, California, 92037
858-822-6100
- Recruiting
University of California San Francisco Helen Diller Family Comprehensive Cancer Center
San Francisco, California, 94158
415-885-7796
- Recruiting
Fred Hutchinson Cancer Center
Seattle, Washington, 98109
206-667-5000
- Recruiting
Moffitt Cancer Center
Tampa, Florida, 33612
888-663-3488
Australia1 site, 1 recruiting
- Recruiting
Peter MacCallum Cancer Centre
Melbourne, Victoria, 3000
03-8559-5000
About this study
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
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.
Read the detailed description
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.
- Conditions
- Non-Small Cell Lung Cancer, NSCLC, PDAC - Pancreatic Ductal Adenocarcinoma, CRC (Colorectal Cancer), Metastatic Non-Small Lung Cell Cancer, Metastatic Colorectal Cancer (CRC)
- Being tested
- BBO-11818, Pembrolizumab, Platinum chemotherapy (cisplatin or carboplatin), Pemetrexed, Cetuximab
- Keywords
- BBOT, BridgeBio Oncology Therapeutics, Phase1, Phase 1a/1b, NSCLC, CRC, PDAC, Metastatic Cancer, Advanced Cancer, Pembrolizumab, Cetuximab, Platinum Chemotherapy, Pemetrexed, KONQUER, KONQUER-101, mFOLFOX6, mFOLFIRINOX, Gemcitabine, Nab-paclitaxel
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Colorectal Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BBO-11818Drug
Participants will receive assigned dose of BBO-11818 orally (PO)
PembrolizumabDrug
Patients will receive IV pembrolizumab
Platinum chemotherapy (cisplatin or carboplatin)Drug
Patients will receive IV platinum chemotherapy (cisplatin or carboplatin)
PemetrexedDrug
Patients will receive IV pemetrexed
CetuximabDrug
Patients will receive IV cetuximab
mFOLFOX6Drug
Patients may receive IV mFOLFOX6
mFOLFOX6Drug
Patients will receive IV mFOLFOX6
BBO-10203Drug
Participants will receive BBO-10203 orally (PO)
mFOLFIRINOXDrug
Patients will receive IV mFOLFIRINOX
GemcitabineDrug
Patients will receive IV gemcitabine
Nab-paclitaxelDrug
Patients will receive IV nab-paclitaxel
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1a - Dose Escalation Monotherapy | Experimental | Participants enrolled in this cohort will receive BBO-11818 as monotherapy Receives: Drug: BBO-11818 |
| Cohort 1b - Dose Escalation Combination Therapy (Pembrolizumab) | Experimental | Participants enrolled in this cohort will receive BBO-11818 in combination with pembrolizumab infusion (IV) Receives: Drug: BBO-11818; Drug: Pembrolizumab |
| 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) Receives: Drug: BBO-11818; Drug: Pembrolizumab; Drug: Platinum chemotherapy (cisplatin or carboplatin); Drug: Pemetrexed |
| 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) Receives: Drug: BBO-11818; Drug: Cetuximab; Drug: mFOLFOX6 |
| 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) Receives: Drug: BBO-11818; Drug: mFOLFOX6; Drug: BBO-10203 |
| 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) Receives: Drug: BBO-11818; Drug: Cetuximab; Drug: BBO-10203 |
| Cohort 1g - Dose Escalation Combination Therapy (Cetuximab) | Experimental | Participants enrolled in this cohort will receive BBO-11818 in combination with cetuximab infusion (IV) Receives: Drug: BBO-11818; Drug: Cetuximab |
| Cohort 1h - Dose Escalation Combination Therapy (mFOLFIRINOX) | Experimental | Participants enrolled in this cohort will receive BBO-11818 in combination with mFOLFIRINOX infusion (IV) Receives: Drug: BBO-11818; Drug: mFOLFIRINOX |
| Cohort 1i - Dose Escalation Combination Therapy (Gemcitabine + Nab-paclitaxel) | Experimental | Participants enrolled in this cohort will receive BBO-11818 in combination with gemcitabine infusion (IV) and nab-paclitaxel infusion (IV) Receives: Drug: BBO-11818; Drug: Gemcitabine; Drug: Nab-paclitaxel |
| Cohort 1j - Dose Escalation Combination Therapy (BBO-10203) | Experimental | Participants enrolled in this cohort will receive BBO-11818 in combination with BBO-10203 Receives: Drug: BBO-11818; Drug: BBO-10203 |
| Cohort 2a - Dose Expansion Monotherapy | Experimental | Participants enrolled in this cohort will receive BBO-11818 as monotherapy Receives: Drug: BBO-11818 |
| Cohort 2b - Dose Expansion Combination (Pembrolizumab) | Experimental | Participants enrolled in this cohort will receive BBO-11818 in combination with pembrolizumab infusion (IV) Receives: Drug: BBO-11818; Drug: Pembrolizumab |
| Cohort 2c - Dose Expansion 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) Receives: Drug: BBO-11818; Drug: Pembrolizumab; Drug: Platinum chemotherapy (cisplatin or carboplatin); Drug: Pemetrexed |
| Cohort 2d - Dose Expansion 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) Receives: Drug: BBO-11818; Drug: Cetuximab; Drug: mFOLFOX6 |
| Cohort 2e - Dose Expansion Combination Therapy (BBO-10203 + mFOLFOX6) | Experimental | Participants enrolled in this cohort will receive BBO-11818 in combination with BBO-10203 and mFOLFOX6 infusion (IV) Receives: Drug: BBO-11818; Drug: mFOLFOX6; Drug: BBO-10203 |
| Cohort 2f - Dose Expansion Combination Therapy (BBO-10203 + Cetuximab) | Experimental | Participants enrolled in this cohort will receive BBO-11818 in combination with BBO-10203 and cetuximab infusion (IV) Receives: Drug: BBO-11818; Drug: Cetuximab; Drug: BBO-10203 |
| Cohort 2g - Dose Expansion Combination Therapy (Cetuximab) | Experimental | Participants enrolled in this cohort will receive BBO-11818 in combination with cetuximab infusion (IV) Receives: Drug: BBO-11818; Drug: Cetuximab |
| Cohort 2h - Dose Expansion Combination Therapy (mFOLFIRINOX) | Experimental | Participants enrolled in this cohort will receive BBO-11818 in combination with mFOLFIRINOX infusion (IV) Receives: Drug: BBO-11818; Drug: mFOLFIRINOX |
| Cohort 2i - Dose Expansion Combination Therapy (Gemcitabine + Nab-paclitaxel) | Experimental | Participants enrolled in this cohort will receive BBO-11818 in combination with gemcitabine infusion (IV) and nab-paclitaxel infusion (IV) Receives: Drug: BBO-11818; Drug: Gemcitabine; Drug: Nab-paclitaxel |
| Cohort 2j - Dose Expansion Combination Therapy (BBO-10203) | Experimental | Participants enrolled in this cohort will receive BBO-11818 in combination with BBO-10203 Receives: Drug: BBO-11818; Drug: BBO-10203 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of treatment emergent adverse events (TEAEs), serious adverse events (SAEs), and dose-limiting toxicities (DLTs)
Measured: approximately 5 years
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
Measured: approximately 5 years
Secondary outcomes (8)
Objective response rate (ORR) per RECIST v1.1 and CNS RECIST
Measured: approximately 5 years
Clinical benefit rate (CBR) per RECIST v1.1
Measured: approximately 5 years
Duration of Response (DOR) per RECIST v1.1
Measured: approximately 5 years
Progression-Free Survival (PFS) per RECIST v1.1
Measured: approximately 5 years
Overall Survival (OS)
Measured: approximately 5 years
Pharmacokinetics of BBO-11818, BBO-10203, irinotecan, and its metabolites (SN-38 and SN-38-G): Maximum blood concentration (Cmax)
Measured: approximately 5 years
Pharmacokinetics of BBO-11818, BBO-10203, irinotecan, and its metabolites (SN-38 and SN-38-G): Time to achieve maximum concentration (Tmax)
Measured: approximately 5 years
Pharmacokinetics of BBO-11818, BBO-10203, irinotecan, and its metabolites (SN-38 and SN-38-G): Area under the concentration-time curve (AUC)
Measured: approximately 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2025
- Study start31 Mar 2025
- Primary completionAug 2027 (estimated)
- Study completionSep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Phase 1a: sequential/parallel, Phase 1b: parallel
- Masking
- None (open label)
- Enrolment
- 665 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06917079
- Sponsor's protocol ID
- TBBO11818-101
- Other IDs
- KONQUER-101
- Status last verified
- May 2026
- First submitted
- 1 Apr 2025
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Stahlhut 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.
PubMed 41790032
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06917079
- Acronym / sponsor ID
- TBBO11818-101
- Conditions
- Non-Small Cell Lung Cancer, NSCLC, PDAC - Pancreatic Ductal Adenocarcinoma, CRC (Colorectal Cancer), Metastatic Non-Small Lung Cell Cancer, Metastatic Colorectal Cancer (CRC)
- Keywords
- BBOT, BridgeBio Oncology Therapeutics, Phase1, Phase 1a/1b, NSCLC, CRC, PDAC, Metastatic Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 665 participants (estimated)
- Lead sponsor
- TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics)Industry (pharma, biotech, devices)
- Study start
- 31 Mar 2025 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Sep 2029 (estimated)
- First posted
- 8 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 20
- Model description
- Phase 1a: sequential/parallel, Phase 1b: parallel
| Arm | Type | Receives |
|---|---|---|
| Cohort 1a - Dose Escalation Monotherapy | Experimental | Drug: BBO-11818Participants enrolled in this cohort will receive BBO-11818 as monotherapy |
| Cohort 1b - Dose Escalation Combination Therapy (Pembrolizumab) | Experimental | Drug: BBO-11818, Drug: PembrolizumabParticipants enrolled in this cohort will receive BBO-11818 in combination with pembrolizumab infusion (IV) |
| Cohort 1c - Dose Escalation Combination Therapy (Pembrolizumab + Cis/carboplatin + Pemetrexed) | Experimental | Drug: BBO-11818, Drug: Pembrolizumab, Drug: Platinum chemotherapy (cisplatin or carboplatin), Drug: PemetrexedParticipants enrolled in this cohort will receive BBO-11818 in combination with pembrolizumab infusion (IV), cis/carboplatin infusion (IV), and pemetrexed infusion (IV) |
| Cohort 1d - Dose Escalation Combination Therapy (Cetuximab ± mFOLFOX6) | Experimental | Drug: BBO-11818, Drug: Cetuximab, Drug: mFOLFOX6Participants enrolled in this cohort will receive BBO-11818 in combination with cetuximab infusion (IV) with or without mFOLFOX6 infusion (IV) |
| Cohort 1e - Dose Escalation Combination Therapy (BBO-10203 + mFOLFOX6) | Experimental | Drug: BBO-11818, Drug: mFOLFOX6, Drug: BBO-10203Participants enrolled in this cohort will receive BBO-11818 in combination with BBO-10203 and mFOLFOX6 infusion (IV) |
| Cohort 1f - Dose Escalation Combination Therapy (BBO-10203 + Cetuximab) | Experimental | Drug: BBO-11818, Drug: Cetuximab, Drug: BBO-10203Participants enrolled in this cohort will receive BBO-11818 in combination with BBO-10203 and cetuximab infusion (IV) |
| Cohort 1g - Dose Escalation Combination Therapy (Cetuximab) | Experimental | Drug: BBO-11818, Drug: CetuximabParticipants enrolled in this cohort will receive BBO-11818 in combination with cetuximab infusion (IV) |
| Cohort 1h - Dose Escalation Combination Therapy (mFOLFIRINOX) | Experimental | Drug: BBO-11818, Drug: mFOLFIRINOXParticipants enrolled in this cohort will receive BBO-11818 in combination with mFOLFIRINOX infusion (IV) |
| Cohort 1i - Dose Escalation Combination Therapy (Gemcitabine + Nab-paclitaxel) | Experimental | Drug: BBO-11818, Drug: Gemcitabine, Drug: Nab-paclitaxelParticipants enrolled in this cohort will receive BBO-11818 in combination with gemcitabine infusion (IV) and nab-paclitaxel infusion (IV) |
| Cohort 1j - Dose Escalation Combination Therapy (BBO-10203) | Experimental | Drug: BBO-11818, Drug: BBO-10203Participants enrolled in this cohort will receive BBO-11818 in combination with BBO-10203 |
| Cohort 2a - Dose Expansion Monotherapy | Experimental | Drug: BBO-11818Participants enrolled in this cohort will receive BBO-11818 as monotherapy |
| Cohort 2b - Dose Expansion Combination (Pembrolizumab) | Experimental | Drug: BBO-11818, Drug: PembrolizumabParticipants enrolled in this cohort will receive BBO-11818 in combination with pembrolizumab infusion (IV) |
| Cohort 2c - Dose Expansion Combination Therapy (Pembrolizumab + Cis/carboplatin + Pemetrexed) | Experimental | Drug: BBO-11818, Drug: Pembrolizumab, Drug: Platinum chemotherapy (cisplatin or carboplatin), Drug: PemetrexedParticipants enrolled in this cohort will receive BBO-11818 in combination with pembrolizumab infusion (IV), cis/carboplatin infusion (IV), and pemetrexed infusion (IV) |
| Cohort 2d - Dose Expansion Combination Therapy (Cetuximab ± mFOLFOX6) | Experimental | Drug: BBO-11818, Drug: Cetuximab, Drug: mFOLFOX6Participants enrolled in this cohort will receive BBO-11818 in combination with cetuximab infusion (IV) with or without mFOLFOX6 infusion (IV) |
| Cohort 2e - Dose Expansion Combination Therapy (BBO-10203 + mFOLFOX6) | Experimental | Drug: BBO-11818, Drug: mFOLFOX6, Drug: BBO-10203Participants enrolled in this cohort will receive BBO-11818 in combination with BBO-10203 and mFOLFOX6 infusion (IV) |
| Cohort 2f - Dose Expansion Combination Therapy (BBO-10203 + Cetuximab) | Experimental | Drug: BBO-11818, Drug: Cetuximab, Drug: BBO-10203Participants enrolled in this cohort will receive BBO-11818 in combination with BBO-10203 and cetuximab infusion (IV) |
| Cohort 2g - Dose Expansion Combination Therapy (Cetuximab) | Experimental | Drug: BBO-11818, Drug: CetuximabParticipants enrolled in this cohort will receive BBO-11818 in combination with cetuximab infusion (IV) |
| Cohort 2h - Dose Expansion Combination Therapy (mFOLFIRINOX) | Experimental | Drug: BBO-11818, Drug: mFOLFIRINOXParticipants enrolled in this cohort will receive BBO-11818 in combination with mFOLFIRINOX infusion (IV) |
| Cohort 2i - Dose Expansion Combination Therapy (Gemcitabine + Nab-paclitaxel) | Experimental | Drug: BBO-11818, Drug: Gemcitabine, Drug: Nab-paclitaxelParticipants enrolled in this cohort will receive BBO-11818 in combination with gemcitabine infusion (IV) and nab-paclitaxel infusion (IV) |
| Cohort 2j - Dose Expansion Combination Therapy (BBO-10203) | Experimental | Drug: BBO-11818, Drug: BBO-10203Participants enrolled in this cohort will receive BBO-11818 in combination with BBO-10203 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Malignancy within the last 2 years as specified in the protocol
- Untreated brain metastases
- Other inclusion/exclusion criteria are specified in the protocol.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BBO-11818Participants will receive assigned dose of BBO-11818 orally (PO) | Drug | Cohort 1a - Dose Escalation Monotherapy, Cohort 1b - Dose Escalation Combination Therapy (Pembrolizumab), Cohort 1c - Dose Escalation Combination Therapy (Pembrolizumab + Cis/carboplatin + Pemetrexed), Cohort 1d - Dose Escalation Combination Therapy (Cetuximab ± mFOLFOX6), Cohort 1e - Dose Escalation Combination Therapy (BBO-10203 + mFOLFOX6), Cohort 1f - Dose Escalation Combination Therapy (BBO-10203 + Cetuximab), Cohort 1g - Dose Escalation Combination Therapy (Cetuximab), Cohort 1h - Dose Escalation Combination Therapy (mFOLFIRINOX), Cohort 1i - Dose Escalation Combination Therapy (Gemcitabine + Nab-paclitaxel), Cohort 1j - Dose Escalation Combination Therapy (BBO-10203), Cohort 2a - Dose Expansion Monotherapy, Cohort 2b - Dose Expansion Combination (Pembrolizumab), Cohort 2c - Dose Expansion Combination Therapy (Pembrolizumab + Cis/carboplatin + Pemetrexed), Cohort 2d - Dose Expansion Combination Therapy (Cetuximab ± mFOLFOX6), Cohort 2e - Dose Expansion Combination Therapy (BBO-10203 + mFOLFOX6), Cohort 2f - Dose Expansion Combination Therapy (BBO-10203 + Cetuximab), Cohort 2g - Dose Expansion Combination Therapy (Cetuximab), Cohort 2h - Dose Expansion Combination Therapy (mFOLFIRINOX), Cohort 2i - Dose Expansion Combination Therapy (Gemcitabine + Nab-paclitaxel), Cohort 2j - Dose Expansion Combination Therapy (BBO-10203) |
| PembrolizumabPatients will receive IV pembrolizumab | Drug | Cohort 1b - Dose Escalation Combination Therapy (Pembrolizumab), Cohort 1c - Dose Escalation Combination Therapy (Pembrolizumab + Cis/carboplatin + Pemetrexed), Cohort 2b - Dose Expansion Combination (Pembrolizumab), Cohort 2c - Dose Expansion Combination Therapy (Pembrolizumab + Cis/carboplatin + Pemetrexed) |
| Platinum chemotherapy (cisplatin or carboplatin)Patients will receive IV platinum chemotherapy (cisplatin or carboplatin) | Drug | Cohort 1c - Dose Escalation Combination Therapy (Pembrolizumab + Cis/carboplatin + Pemetrexed), Cohort 2c - Dose Expansion Combination Therapy (Pembrolizumab + Cis/carboplatin + Pemetrexed) |
| PemetrexedPatients will receive IV pemetrexed | Drug | Cohort 1c - Dose Escalation Combination Therapy (Pembrolizumab + Cis/carboplatin + Pemetrexed), Cohort 2c - Dose Expansion Combination Therapy (Pembrolizumab + Cis/carboplatin + Pemetrexed) |
| CetuximabPatients will receive IV cetuximab | Drug | Cohort 1d - Dose Escalation Combination Therapy (Cetuximab ± mFOLFOX6), Cohort 1f - Dose Escalation Combination Therapy (BBO-10203 + Cetuximab), Cohort 1g - Dose Escalation Combination Therapy (Cetuximab), Cohort 2d - Dose Expansion Combination Therapy (Cetuximab ± mFOLFOX6), Cohort 2f - Dose Expansion Combination Therapy (BBO-10203 + Cetuximab), Cohort 2g - Dose Expansion Combination Therapy (Cetuximab) |
| mFOLFOX6Patients may receive IV mFOLFOX6 | Drug | Cohort 1d - Dose Escalation Combination Therapy (Cetuximab ± mFOLFOX6), Cohort 2d - Dose Expansion Combination Therapy (Cetuximab ± mFOLFOX6) |
| mFOLFOX6Patients will receive IV mFOLFOX6 | Drug | Cohort 1e - Dose Escalation Combination Therapy (BBO-10203 + mFOLFOX6), Cohort 2e - Dose Expansion Combination Therapy (BBO-10203 + mFOLFOX6) |
| BBO-10203Participants will receive BBO-10203 orally (PO) | Drug | Cohort 1e - Dose Escalation Combination Therapy (BBO-10203 + mFOLFOX6), Cohort 1f - Dose Escalation Combination Therapy (BBO-10203 + Cetuximab), Cohort 1j - Dose Escalation Combination Therapy (BBO-10203), Cohort 2e - Dose Expansion Combination Therapy (BBO-10203 + mFOLFOX6), Cohort 2f - Dose Expansion Combination Therapy (BBO-10203 + Cetuximab), Cohort 2j - Dose Expansion Combination Therapy (BBO-10203) |
| mFOLFIRINOXPatients will receive IV mFOLFIRINOX | Drug | Cohort 1h - Dose Escalation Combination Therapy (mFOLFIRINOX), Cohort 2h - Dose Expansion Combination Therapy (mFOLFIRINOX) |
| GemcitabinePatients will receive IV gemcitabine | Drug | Cohort 1i - Dose Escalation Combination Therapy (Gemcitabine + Nab-paclitaxel), Cohort 2i - Dose Expansion Combination Therapy (Gemcitabine + Nab-paclitaxel) |
| Nab-paclitaxelPatients will receive IV nab-paclitaxel | Drug | Cohort 1i - Dose Escalation Combination Therapy (Gemcitabine + Nab-paclitaxel), Cohort 2i - Dose Expansion Combination Therapy (Gemcitabine + Nab-paclitaxel) |
Primary outcome
Incidence and severity of treatment emergent adverse events (TEAEs), serious adverse events (SAEs), and dose-limiting toxicities (DLTs)
Time frame: approximately 5 years
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
8 secondary outcomes
Objective response rate (ORR) per RECIST v1.1 and CNS RECIST
Time frame: approximately 5 years
Clinical benefit rate (CBR) per RECIST v1.1
Time frame: approximately 5 years
Duration of Response (DOR) per RECIST v1.1
Time frame: approximately 5 years
Progression-Free Survival (PFS) per RECIST v1.1
Time frame: approximately 5 years
Overall Survival (OS)
Time frame: approximately 5 years
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
Pharmacokinetics of BBO-11818, BBO-10203, irinotecan, and its metabolites (SN-38 and SN-38-G): Time to achieve maximum concentration (Tmax)
Time frame: approximately 5 years
Pharmacokinetics of BBO-11818, BBO-10203, irinotecan, and its metabolites (SN-38 and SN-38-G): Area under the concentration-time curve (AUC)
Time frame: approximately 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
- Derived from this study: PubMed 41790032Stahlhut 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics) contact
17 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BBO-11818, Pembrolizumab and Platinum chemotherapy (cisplatin or carboplatin) in people with Non-Small Cell Lung Cancer and NSCLC, run by TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics) at 17 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United States, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics) ((650) 405-4770, tbbo11818-101ct.gov@bbotx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of treatment emergent adverse events (TEAEs), serious adverse events (SAEs), and dose-limiting toxicities (DLTs) (time frame: approximately 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06917079, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2026.