A Phase Ia/Ib 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

Study Identifier:
TBBO8520-101
CT.gov Identifier:
NCT06343402
EudraCT Identifier:
202451000000
EU Trial (CTIS) Number:
N/A
Study Contact Information:
N/A
Recruiting

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Study Summary

A first in human study to evaluate the safety, tolerability, and pharmacokinetics (PK) of BBO-8520, a KRAS G12C (ON) inhibitor, single agent and in combination with pembrolizumab and BBO-10203 in patients with advanced non-small cell lung cancer To evaluate KRAS inhibitors in patients with KRASG12C mutant non-small cell lung cancer To evaluate at escalating doses as monotherapy and in combination with pembrolizumab.

To evaluate the safety, tolerability, preliminary antitumor activity, and pharmacokinetics of BBO-8520 as a single agent and in combination with pembrolizumab in patients with KRASG12C mutant NSCLC.

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
  • Non-Small Cell Lung Cancer
  • Gene Mutations
  • Metastatic Lung Cancer
  • Other Lung Cancer
    • Phase
    The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
    I
    Sex
    Female & Male
    Age
    18+ years
    Study Drug
  • Drug: Experimental: Cohort 1a - Dose Escalation/Dose Finding Monotherapy
    • Study Status
    Indicates the current recruitment status or the expanded access status
    Recruiting

    Requirements information
    Inclusion criteria
    • 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 Documented KRASG12C mutation; no other targetable driver mutations, eg EGFR, ALK, ROS1/BRAF/RET/MET/EGFR exon 20 insertion/NTRK/HER2 Phase 1a BBO-8520 monotherapy dose escalation cohort: Progression on or recurrence after prior standard of care therapy (including ICI and/or platinum-based doublet) Prior KRASG12C [OFF] inhibitor allowed Phase 1a BBO-8520 + pembrolizumab dose-escalation cohort: Prior ICI and/or platinum-based doublet allowed Prior KRASG12C [OFF] inhibitor allowed Phase 1b dose-expansion cohorts: • No prior KRASG12C [OFF] inhibitor monotherapy cohort: • Progression on or recurrence after 21 prior standard of care therapy, including ICI, platinum-based doublet, or both No prior KRASG12C [OFF] inhibitor Prior KRASG12C [OFF] inhibitor monotherapy cohort: Progression on or recurrence after ≥1 prior standard of care therapy (including ICI, platinum-based doublet, or both) and KRASG12C [OFF] inhibitor BBO-8520 + pembrolizumab cohort: • No prior therapy for NSCLC; no prior KRASG12C [OFF] inhibitor, ICI, or platinum-based therapy
    Exclusion criteria
    • - 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 2a 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 Key exclusion criteria Inadequate organ function Active hepatitis B or C infection; known positive HIV test Significant cardiovascular disease Untreated brain metastases; patients with stable brain metastases are allowed

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    Study Locations

    Location
    Investigator
    Status
    Condition(s) Treated at Site
    Location
    START Madrid, Spain (FJD)
    Madrid, Spain, 28040
    Investigator
    Victor Moreno Garcia
    Status
    Will Be Recruiting
    Condition(s) Treated at Site
    Non-Small Cell Lung Cancer
    Gene Mutations
    Metastatic Lung Cancer
    Other Lung Cancer