BBO-11818 in Adult Subjects With KRAS Mutant Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: BBO-11818, Pembrolizumab, Platinum chemotherapy (cisplatin or carboplatin), Pemetrexed.
- Who it may be relevant to
- Registry conditions: Non-Small Cell Lung Cancer, NSCLC, PDAC - Pancreatic Ductal Adenocarcinoma, CRC (Colorectal Cancer). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Australia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Interventions
- Drug BBO-11818
Participants will receive assigned dose of BBO-11818 orally (PO) - Drug Pembrolizumab
Patients will receive IV pembrolizumab - Drug Platinum chemotherapy (cisplatin or carboplatin)
Patients will receive IV platinum chemotherapy (cisplatin or carboplatin) - Drug Pemetrexed
Patients will receive IV pemetrexed - Drug Cetuximab
Patients will receive IV cetuximab - Drug mFOLFOX6
Patients may receive IV mFOLFOX6 - Drug mFOLFOX6
Patients will receive IV mFOLFOX6 - Drug BBO-10203
Participants will receive BBO-10203 orally (PO) - Drug mFOLFIRINOX
Patients will receive IV mFOLFIRINOX - Drug Gemcitabine
Patients will receive IV gemcitabine
Primary outcome measures
- 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]
Secondary outcome measures (8)
- 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]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 16 centers
- The Angeles Clinic and Research Institute - West Los Angeles Office — Los Angeles
- University of California Davis — Sacramento
- University of California San Diego Moores Cancer Center — San Diego
- University of California San Francisco Helen Diller Family Comprehensive Cancer Center — San Francisco
- Yale University — New Haven
- Moffitt Cancer Center — Tampa
- OSF Healthcare Cancer Institute — Peoria
- Massachusetts General Hospital — Boston
- … and 8 more centers
Australia · 1 center
- Peter MacCallum Cancer Centre — Melbourne
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 PMID 41790032
Identifiers
NCT: NCT06917079 · TBBO11818-101 · KONQUER-101