BBO-11818 in Adult Subjects With KRAS Mutant Cancer

NCT06917079
clinicaltrials.gov
Phase
Phase 1
clinicaltrials.gov
Recruitment status
Recruiting
clinicaltrials.gov
Participants
665
clinicaltrials.gov
Lead sponsor
TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics)
clinicaltrials.gov
Start date
2025-03-31
clinicaltrials.gov
Number of sites
17
clinicaltrials.gov

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.
clinicaltrials.gov
Short title
BBO-11818 in Adult Subjects With KRAS Mutant Cancer
clinicaltrials.gov
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

Control arm
Open label
clinicaltrials.gov
Registry reports results
No
clinicaltrials.gov
Listing at source
Listed
clinicaltrials.gov
Recruitment status
Recruiting
clinicaltrials.gov
Phase
Phase 1
clinicaltrials.gov
Study type
Interventional
clinicaltrials.gov

Completion date
2029-09-01
clinicaltrials.gov
First posted
2025-04-08
clinicaltrials.gov
Registry last updated
2026-06-02
clinicaltrials.gov
Primary completion date
2027-08-01
clinicaltrials.gov
Start date
2025-03-31
clinicaltrials.gov

Participants
665
clinicaltrials.gov
Participant count basis
Estimated
clinicaltrials.gov
Planned participants
665
clinicaltrials.gov
Protocol amendments
5
clinicaltrials.gov
Number of sites
17
clinicaltrials.gov

Data monitoring committee
No
clinicaltrials.gov
Registry sponsor category
Industry
clinicaltrials.gov
Lead sponsor
TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics)
clinicaltrials.gov
Source registry
ClinicalTrials.gov
clinicaltrials.gov

Registry ID
NCT06917079
clinicaltrials.gov
ClinicalTrials.gov ID
NCT06917079
clinicaltrials.gov
Registry record
Open registry record
clinicaltrials.gov

Allocation
Not randomised
Model
Sequential
Purpose
Treatment
Masking
No masking
Sources for study design
clinicaltrials.gov

  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

  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
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

  • 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

  • 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
clinicaltrials.gov

  • 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
clinicaltrials.gov

Other registry identifiers

  • KONQUER-101
Sources for references
clinicaltrials.gov

Related records

Drugs (7)

Lead sponsors (1)

Conditions (6)

Targets (34)