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

April 19, 2024 updated by: TheRas, Inc

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

160

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
    • Victoria
      • Melbourne, Victoria, Australia, 3051
        • Recruiting
        • Peter MacCallum Cancer Centre
  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Recruiting
        • Cleveland Clinic
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Recruiting
        • SCRI Oncology Partners
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Recruiting
        • NEXT Oncology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse Events
Time Frame: approximately 3 years
Incidence and severity of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs)
approximately 3 years
Dose-limiting toxicities (DLTs)
Time Frame: approximately 3 years
Number of participants with dose limiting toxicities
approximately 3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: approximately 3 years
approximately 3 years
To evaluate preliminary antitumor activity of BBO-8520
Time Frame: approximately 3 years
Progression-free survival (PFS) per (RECIST v1.1)
approximately 3 years
To evaluate preliminary antitumor activity of BBO-8520
Time Frame: approximately 3 years
Duration of response (DOR) per (RECIST v1.1)
approximately 3 years
To characterize the pharmacokinetics (PK) of BBO-8520
Time Frame: approximately 3 years
Area under the curve (AUC)
approximately 3 years
To characterize the pharmacokinetics (PK) of BBO-8520
Time Frame: approximately 3 years
Peak plasma drug concentration (Cmax)
approximately 3 years
To characterize the pharmacokinetics (PK) of BBO-8520
Time Frame: approximately 3 years
Time to Cmax (Tmax)
approximately 3 years
To characterize the pharmacokinetics (PK) of BBO-8520
Time Frame: approximately 3 years
Half life (T1/2)
approximately 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

TheRas, Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2024

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

February 1, 2028

Study Registration Dates

First Submitted

March 22, 2024

First Submitted That Met QC Criteria

April 1, 2024

First Posted (Actual)

April 2, 2024

Study Record Updates

Last Update Posted (Actual)

April 22, 2024

Last Update Submitted That Met QC Criteria

April 19, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TBBO8520-101
  • ONKORAS-101 (Other Identifier: TheRas)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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