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NCT Number: NCT06343402

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

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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Key information

Conditions

Non-small Cell Lung Cancer Advanced Lung Carcinoma Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung KRAS G12C Lung Diseases Lung Neoplasms Metastatic Lung Cancer Metastatic Non-small Cell Lung Cancer NSCLC Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Kinghorn Cancer Centre, Darlinghurst, New South Wales, Australia

Loading trial locations.

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BBO-8520

Drug

Participants will receive assigned dose of BBO-8520 orally (PO), QD

Pembrolizumab

Drug

Patients will receive IV pembrolizumab

BBO-10203

Drug

Participants will receive assigned dose of BBO-8520 orally (PO), QD

Primary outcomes

  1. Adverse Events

    Time frame: approximately 3 years

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

  2. Dose-limiting toxicities (DLTs)

    Time frame: approximately 3 years

    Number of participants with dose limiting toxicities

Secondary outcomes

  1. To evaluate preliminary antitumor activity of BBO-8520

    Time frame: approximately 3 years

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

  2. To evaluate preliminary antitumor activity of BBO-8520

    Time frame: approximately 3 years

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

  3. To evaluate preliminary antitumor activity of BBO-8520

    Time frame: approximately 3 years

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

  4. Overall Survival (OS)

    Time frame: approximately 3 years

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

    Time frame: approximately 3 years

    Area under the curve (AUC)

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

    Time frame: approximately 3 years

    Peak plasma drug concentration (Cmax)

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

    Time frame: approximately 3 years

    Time to Cmax (Tmax)

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

    Time frame: approximately 3 years

    Half life (T1/2)

Study contacts

Contact information is provided by the study sponsor or research team.

TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics)

CONTACT

[email protected]

650-405-8440

Sponsors and collaborators

Lead sponsor

TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics)

Industry

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2031
Study completion
2031
First posted
Apr 2, 2024
Registry last updated
May 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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