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

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ClinicalTrials.gov Identifier: NCT06343402
Recruitment Status : Recruiting
First Posted : April 2, 2024
Last Update Posted : April 22, 2024
Sponsor:
Information provided by (Responsible Party):
TheRas, Inc

Study Description
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Brief 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 in patients with advanced non-small cell lung cancer

Condition or disease Intervention/treatment Phase
Non-small Cell Lung Cancer Metastatic Non-Small Cell Lung Cancer NSCLC KRAS G12C Metastatic Lung Cancer Advanced Lung Carcinoma Drug: BBO-8520 Drug: Pembrolizumab Phase 1

Detailed Description:
This is an open-label, multi-center Phase 1a/1b study designed to evaluate the safety, tolerability, preliminary antitumor activity, and PK of BBO-8520 as a single agent and in combination with pembrolizumab in patients with KRAS (Kirsten rat sarcoma) G12C mutant non-small cell lung cancer. The study includes dose escalation phase, and expansion phase
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: Phase 1a: sequential/parallel, Phase 1b: parallel
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1a/1b Open-Label Study of BBO-8520 Monotherapy and BBO-8520 in Combination With Pembrolizumab in Subjects With Advanced KRASG12C Mutant Non-Small Cell Lung Cancer - the ONKORAS-101 Study
Estimated Study Start Date : April 2024
Estimated Primary Completion Date : August 2027
Estimated Study Completion Date : February 2028

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: Cohort 1a - Dose Escalation/Dose Finding Monotherapy
Participants enrolled in this cohort will receive BBO-8520 (different dose levels will be evaluated) once a day (QD) as monotherapy
 Drug: BBO-8520
Participants will receive assigned dose of BBO-8520 orally (PO), QD
Experimental: Cohort 1b - Dose Escalation/Dose Finding Combination Therapy
Participants enrolled in this cohort will receive BBO-8520 (different dose levels will be evaluated) once a day (QD) in combination with pembrolizumab infusion (IV)
 Drug: BBO-8520
Participants will receive assigned dose of BBO-8520 orally (PO), QD

Drug: Pembrolizumab
Patients will receive IV pembrolizumab
Experimental: Cohort 2a - Dose Expansion Monotherapy
Participants enrolled in this cohort will receive BBO-8520 once a day (QD) as monotherapy
 Drug: BBO-8520
Participants will receive assigned dose of BBO-8520 orally (PO), QD
Experimental: Cohort 2b - Dose Expansion Combination Therapy
Participants enrolled in this cohort will receive BBO-8520 once a day (QD) in combination with pembrolizumab infusion (IV)
 Drug: BBO-8520
Participants will receive assigned dose of BBO-8520 orally (PO), QD

Drug: Pembrolizumab
Patients will receive IV pembrolizumab


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  1. To evaluate preliminary antitumor activity of BBO-8520 [ Time Frame: approximately 3 years ]
    Progression-free survival (PFS) 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. Overall Survival (OS) [ Time Frame: approximately 3 years ]
  4. To characterize the pharmacokinetics (PK) of BBO-8520 [ Time Frame: approximately 3 years ]
    Area under the curve (AUC)

  5. To characterize the pharmacokinetics (PK) of BBO-8520 [ Time Frame: approximately 3 years ]
    Peak plasma drug concentration (Cmax)

  6. To characterize the pharmacokinetics (PK) of BBO-8520 [ Time Frame: approximately 3 years ]
    Time to Cmax (Tmax)

  7. To characterize the pharmacokinetics (PK) of BBO-8520 [ Time Frame: approximately 3 years ]
    Half life (T1/2)


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically documented locally advanced 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 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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06343402


Contacts
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Contact: TheRas 650-391-9740 onkoras101ct.gov@bridgebio.com

Locations
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United States, Ohio
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
United States, Tennessee
SCRI Oncology Partners Recruiting
Nashville, Tennessee, United States, 37203
United States, Virginia
NEXT Oncology Recruiting
Fairfax, Virginia, United States, 22031
Australia, Victoria
Peter MacCallum Cancer Centre Recruiting
Melbourne, Victoria, Australia, 3051
Sponsors and Collaborators
TheRas, Inc
More Information
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Responsible Party: TheRas, Inc
ClinicalTrials.gov Identifier: NCT06343402    
Other Study ID Numbers: TBBO8520-101
ONKORAS-101 ( Other Identifier: TheRas )
First Posted: April 2, 2024    Key Record Dates
Last Update Posted: April 22, 2024
Last Verified: April 2024

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
 Carcinoma, Bronchogenic
Bronchial Neoplasms
Pembrolizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action