Open-label Study of BBO-8520 in Adult Subjects With KRASG12C Non-small Cell Lung Cancer

NCT06343402
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Phase
Phase 1
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Recruitment status
Recruiting
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Participants
350
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Lead sponsor
TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics)
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Start date
2024-05-22
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Number of sites
35
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Summary
A first in human study to evaluate the safety and preliminary antitumor activity of BBO-8520, a KRAS G12C (ON and OFF) inhibitor, as a single agent and in combination with pembrolizumab and BBO-10203 in subjects with locally advanced and unresectable or metastatic non-small cell lung cancer with a KRAS (Kirsten rat sarcoma) G12C mutation.
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Short title
Open-label Study of BBO-8520 in Adult Subjects With KRASG12C Non-small Cell Lung Cancer
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Official title
A Phase 1a/1b Open-Label Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of BBO-8520 in Subjects With Advanced KRASG12C Mutant Non-Small Cell Lung Cancer - The ONKORAS-101 Study
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Control arm
Open label
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Recruiting
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Phase
Phase 1
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Study type
Interventional
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Completion date
2031-09-01
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First posted
2024-04-02
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Registry last updated
2026-05-05
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Primary completion date
2031-04-01
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Start date
2024-05-22
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Participants
350
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Participant count basis
Estimated
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Planned participants
350
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Protocol amendments
4
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Number of sites
35
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Data monitoring committee
No
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Registry sponsor category
Industry
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Lead sponsor
TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics)
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Source registry
ClinicalTrials.gov
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Registry ID
NCT06343402
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ClinicalTrials.gov ID
NCT06343402
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Registry record
Open registry record
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Allocation
Not randomised
Model
Sequential
Purpose
Treatment
Masking
No masking
Sources for study design
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  1. Adverse Events

    Timeframe: approximately 3 years

    Incidence and severity of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs)

  2. Dose-limiting toxicities (DLTs)

    Timeframe: approximately 3 years

    Number of participants with dose limiting toxicities

  1. To evaluate preliminary antitumor activity of BBO-8520

    Timeframe: approximately 3 years

    Objective response rate (ORR) per (RECIST v1.1)

  2. To evaluate preliminary antitumor activity of BBO-8520

    Timeframe: approximately 3 years

    Duration of Response (DOR) per (RECIST v1.1)

  3. To evaluate preliminary antitumor activity of BBO-8520

    Timeframe: approximately 3 years

    Progression-free survival (PFS) per (RECIST v1.1)

  4. Overall Survival (OS)

    Timeframe: approximately 3 years

  5. To characterize the pharmacokinetics (PK) of BBO-8520

    Timeframe: approximately 3 years

    Area under the curve (AUC)

  6. To characterize the pharmacokinetics (PK) of BBO-8520

    Timeframe: approximately 3 years

    Peak plasma drug concentration (Cmax)

  7. To characterize the pharmacokinetics (PK) of BBO-8520

    Timeframe: approximately 3 years

    Time to Cmax (Tmax)

  8. To characterize the pharmacokinetics (PK) of BBO-8520

    Timeframe: approximately 3 years

    Half life (T1/2)

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 non-small cell lung cancer with a KRAS G12C mutation
  • Measurable disease by RECIST v1.1
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1

  • Patients with malignancy within the last 2 years as specified in the protocol
  • Patients with untreated or unstable brain metastases
  • Patients with known hypersensitivity to BBO-8520 or its excipients
  • For Cohorts 1b and 2b:
  • Patients with a known hypersensitivity to pembrolizumab or its excipients
  • Patients with active autoimmune disease of history of autoimmune disease that might recur
  • Patients with a history of interstitial lung disease/pneumonitis that required steroids, or current interstitial lung disease/pneumonitis

Other inclusion/exclusion criteria may apply

Sources for eligibility
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  • O'Neal Comprehensive Cancer Center at UABBirmingham, United StatesRecruiting
  • University of California - San Diego Moores Cancer CenterLa Jolla, United StatesRecruiting
  • University of California San FranciscoSan Francisco, United StatesRecruiting
  • UCLA Health - Santa Monica Cancer CareSanta Monica, United StatesRecruiting
  • University of Colorado Cancer CenterAurora, United StatesRecruiting
  • Yale Cancer CenterNew Haven, United StatesRecruiting
  • Norwalk HospitalNorwalk, United StatesRecruiting
  • OSF Saint Francis Medical CenterPeoria, United StatesRecruiting
  • University of Kansas Medical CenterKansas City, United StatesRecruiting
  • Henry Ford Cancer - DetroitDetroit, United StatesRecruiting
  • Roswell Park Cancer InstituteBuffalo, United StatesRecruiting
  • Perlmutter Cancer Center - NYU Langone HealthNew York, United StatesRecruiting
  • Memorial Sloan Kettering Cancer CenterNew York, United StatesRecruiting
  • Cleveland ClinicCleveland, United StatesRecruiting
  • USOR - Oncology Associates of Oregon, P.CEugene, United StatesRecruiting
  • SCRI Oncology PartnersNashville, United StatesRecruiting
  • Oncology Consultants Texas Medical CenterHouston, United StatesRecruiting
  • USOR - Texas Oncology - (DFW) WacoWaco, United StatesRecruiting
  • Huntsman Cancer InstituteSalt Lake City, United StatesRecruiting
  • NEXT OncologyFairfax, United StatesRecruiting
  • Fred Hutchinson Cancer CenterSeattle, United StatesRecruiting
  • Northwest Medical SpecialtiesTacoma, United StatesRecruiting
  • Kinghorn Cancer CentreDarlinghurst, AustraliaRecruiting
  • Flinders Medical CentreBedford Park, AustraliaRecruiting
  • The Queen Elizabeth HospitalWoodville South, AustraliaRecruiting

And 10 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

Other registry identifiers

  • ONKORAS-101
Sources for references
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (4)

Targets (1)