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Recruiting NCT06343402

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

Phase I Interventional Non-small Cell Lung Cancer Metastatic Non-Small Cell Lung Cancer NSCLC KRAS G12C

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-8520, Pembrolizumab, BBO-10203.
Who it may be relevant to
Registry conditions: Non-small Cell Lung Cancer, Metastatic Non-Small Cell Lung Cancer, NSCLC, KRAS G12C. 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, Canada, Denmark, Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Detailed description

This is an open-label, multi-center, Phase 1 study designed to evaluate the safety, tolerability, pharmacokinetics, and efficacy of BBO-8520, a direct inhibitor of KRASG12C (ON and OFF), alone and in combination with the ICI 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. The study includes dose escalation phase and dose expansion phase

Interventions

  • Drug BBO-8520
    Participants will receive assigned dose of BBO-8520 orally (PO), QD
  • Drug Pembrolizumab
    Patients will receive IV pembrolizumab
  • Drug BBO-10203
    Participants will receive assigned dose of BBO-8520 orally (PO), QD

Primary outcome measures

  • Adverse Events [Time frame: approximately 3 years]
  • Dose-limiting toxicities (DLTs) [Time frame: approximately 3 years]
Secondary outcome measures (8)
  • To evaluate preliminary antitumor activity of BBO-8520 [Time frame: approximately 3 years]
  • To evaluate preliminary antitumor activity of BBO-8520 [Time frame: approximately 3 years]
  • To evaluate preliminary antitumor activity of BBO-8520 [Time frame: approximately 3 years]
  • Overall Survival (OS) [Time frame: approximately 3 years]
  • To characterize the pharmacokinetics (PK) of BBO-8520 [Time frame: approximately 3 years]
  • To characterize the pharmacokinetics (PK) of BBO-8520 [Time frame: approximately 3 years]
  • To characterize the pharmacokinetics (PK) of BBO-8520 [Time frame: approximately 3 years]
  • To characterize the pharmacokinetics (PK) of BBO-8520 [Time frame: approximately 3 years]

Eligibility criteria

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

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 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

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 · 22 centers
  • O'Neal Comprehensive Cancer Center at UAB — Birmingham
  • University of California - San Diego Moores Cancer Center — La Jolla
  • University of California San Francisco — San Francisco
  • UCLA Health - Santa Monica Cancer Care — Santa Monica
  • University of Colorado Cancer Center — Aurora
  • Yale Cancer Center — New Haven
  • Norwalk Hospital — Norwalk
  • OSF Saint Francis Medical Center — Peoria
  • … and 14 more centers
Australia · 6 centers
  • Kinghorn Cancer Centre — Darlinghurst
  • Flinders Medical Centre — Bedford Park
  • The Queen Elizabeth Hospital — Woodville South
  • Peninsula & South Eastern Hematology and Oncology Group (PAS) — Frankston
  • Peter MacCallum Cancer Centre — Melbourne
  • Linear Clinical Research — Nedlands
Canada · 3 centers
  • Juravinski Cancer Centre — Hamilton
  • The Princess Margaret Cancer Centre — Toronto
  • Jewish General Hospital — Montreal
Spain · 3 centers
  • START Barcelona - Hospital HM Nou Delfos — Barcelona
  • START Madrid - Hospital Universitario Fundación Jiménez Díaz — Madrid
  • Hospital Universitario Quirónsalud Madrid — Madrid
Denmark · 1 center
  • Rigshospitalet — Copenhagen

Identifiers

NCT: NCT06343402 · TBBO8520-101 · ONKORAS-101

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗