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Non-small Cell Lung CancerPhase 1NCT06343402

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

A Phase 1 study testing BBO-8520, Pembrolizumab and BBO-10203 in people with Non-small Cell Lung Cancer and Metastatic Non-Small Cell Lung Cancer, run by TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics) at 38 sites in 5 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
BBO-8520, Pembrolizumab and BBO-10203
Could I receive a placebo?
No, everyone receives an active treatment
How many people
350 participants
Where
38 sitesin 5 countries
Study dates
22 May 2024to Sep 2031
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

38 sites in 5 countries. Contact the study team or a site near you to ask about taking part.

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

650-405-8440

onkoras-101ct.gov@bridgebiooncology.com

38 sites in 5 countries

United States23 sites, 23 recruiting

  • University of Colorado Cancer Center

    Aurora, Colorado, 80045

    Recruiting

  • University of Maryland Marlene & Stewart Greenebaum Comprehensive Cancer Center

    Baltimore, Maryland, 21201

    Recruiting

  • O'Neal Comprehensive Cancer Center at UAB

    Birmingham, Alabama, 35233

    Recruiting

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

    Recruiting

  • Cleveland Clinic

    Cleveland, Ohio, 44195

    Recruiting

  • Henry Ford Cancer - Detroit

    Detroit, Michigan, 48282

    Recruiting

  • USOR - Oncology Associates of Oregon, P.C

    Eugene, Oregon, 97401

    Recruiting

  • NEXT Oncology

    Fairfax, Virginia, 22031

    Recruiting

  • Oncology Consultants Texas Medical Center

    Houston, Texas, 77030

    Recruiting

  • University of Kansas Medical Center

    Kansas City, Kansas, 66205

    Recruiting

  • University of California - San Diego Moores Cancer Center

    La Jolla, California, 92093

    Recruiting

  • SCRI Oncology Partners

    Nashville, Tennessee, 37203

    Recruiting

  • Yale Cancer Center

    New Haven, Connecticut, 06510

    Recruiting

  • Perlmutter Cancer Center - NYU Langone Health

    New York, New York, 10016

    Recruiting

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

    Recruiting

  • Norwalk Hospital

    Norwalk, Connecticut, 06850

    Recruiting

  • OSF Saint Francis Medical Center

    Peoria, Illinois, 61603

    Recruiting

  • Huntsman Cancer Institute

    Salt Lake City, Utah, 84112

    Recruiting

  • University of California San Francisco

    San Francisco, California, 94158

    Recruiting

  • UCLA Health - Santa Monica Cancer Care

    Santa Monica, California, 90404

    Recruiting

  • Fred Hutchinson Cancer Center

    Seattle, Washington, 98109

    Recruiting

  • Northwest Medical Specialties

    Tacoma, Washington, 98405

    Recruiting

  • USOR - Texas Oncology - (DFW) Waco

    Waco, Texas, 76710

    Recruiting

Other trials in United States

Australia6 sites, 6 recruiting

  • Flinders Medical Centre

    Bedford Park, South Australia, 5042

    Recruiting

  • Kinghorn Cancer Centre

    Darlinghurst, New South Wales, 2010

    Recruiting

  • Peninsula & South Eastern Hematology and Oncology Group (PAS)

    Frankston, Victoria, 3199

    Recruiting

  • Peter MacCallum Cancer Centre

    Melbourne, Victoria, 3051

    Recruiting

  • Linear Clinical Research

    Nedlands, Western Australia, 6009

    Recruiting

  • The Queen Elizabeth Hospital

    Woodville South, South Australia, 5011

    Recruiting

Other trials in Australia

Canada4 sites, 4 recruiting

  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2

    Recruiting

  • Juravinski Cancer Centre

    Hamilton, Ontario, L8V 5C2

    Recruiting

  • Jewish General Hospital

    Montreal, Quebec, H3T 1E2

    Recruiting

  • The Princess Margaret Cancer Centre

    Toronto, Ontario, M5G 2C4

    Recruiting

Other trials in Canada

Spain4 sites, 4 recruiting

  • START Barcelona - Hospital HM Nou Delfos

    Barcelona, 08023

    Recruiting

  • Vall d'Hebron University Hospital

    Horta-Guinardó, Barcelona, 08035

    Recruiting

  • START Madrid - Hospital Universitario Fundación Jiménez Díaz

    Madrid, 28040

    Recruiting

  • Hospital Universitario Quirónsalud Madrid

    Madrid, 28223

    Recruiting

Other trials in Spain

Denmark1 site, 1 recruiting

  • Rigshospitalet

    Copenhagen, 2100

    Recruiting

Other trials in Denmark

About this study

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

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.

Read the 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

Being tested
BBO-8520, Pembrolizumab, BBO-10203
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Lung Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BBO-8520Drug

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

  • PembrolizumabDrug

    Patients will receive IV pembrolizumab

  • BBO-10203Drug

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

Study groups in NCT06343402
Study groupRoleWhat they receive
Cohort 1a - Dose Escalation/Dose Finding MonotherapyExperimentalParticipants enrolled in this cohort will receive BBO-8520 (different dose levels will be evaluated) once a day (QD) as monotherapy
Receives: Drug: BBO-8520
Cohort 1b - Dose Escalation/Dose Finding Combination TherapyExperimentalParticipants enrolled in this cohort will receive BBO-8520 (different dose levels will be evaluated) once a day (QD) in combination with pembrolizumab infusion (IV)
Receives: Drug: BBO-8520; Drug: Pembrolizumab
Cohort 2a - Dose Expansion MonotherapyExperimentalParticipants enrolled in this cohort will receive BBO-8520 once a day (QD) as monotherapy
Receives: Drug: BBO-8520
Cohort 2b - Dose Expansion Combination TherapyExperimentalParticipants enrolled in this cohort will receive BBO-8520 once a day (QD) in combination with pembrolizumab infusion (IV)
Receives: Drug: BBO-8520; Drug: Pembrolizumab
Cohort 1b Safety Lead-In - Dose Expansion Doublet Combination TherapyExperimentalParticipants enrolled in this cohort will receive BBO-8520 once a day (QD) in combination with BBO-10203 once a day (QD)
Receives: Drug: BBO-8520; Drug: BBO-10203
Cohort 1b - Dose Expansion Doublet Combination TherapyExperimentalParticipants enrolled in this cohort will receive BBO-8520 once a day (QD) in combination with BBO-10203 once a day (QD)
Receives: Drug: BBO-8520; Drug: BBO-10203
Cohort 1b Safety Lead-In - Dose Expansion Triplet Combination TherapyExperimentalParticipants enrolled in this cohort will receive BBO-8520 once a day (QD) in combination with BBO-10203 once a day (QD) and pembrolizumab infusion (IV)
Receives: Drug: BBO-8520; Drug: Pembrolizumab; Drug: BBO-10203
Cohort 1b - Dose Expansion Triplet Combination TherapyExperimentalParticipants enrolled in this cohort will receive BBO-8520 once a day (QD) in combination with BBO-10203 once a day (QD) and pembrolizumab infusion (IV)
Receives: Drug: BBO-8520; Drug: Pembrolizumab; Drug: BBO-10203

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adverse Events

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

    Measured: approximately 3 years

  2. Dose-limiting toxicities (DLTs)

    Number of participants with dose limiting toxicities

    Measured: approximately 3 years

Secondary outcomes (8)

  1. To evaluate preliminary antitumor activity of BBO-8520

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

    Measured: approximately 3 years

  2. To evaluate preliminary antitumor activity of BBO-8520

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

    Measured: approximately 3 years

  3. To evaluate preliminary antitumor activity of BBO-8520

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

    Measured: approximately 3 years

  4. Overall Survival (OS)

    Measured: approximately 3 years

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

    Area under the curve (AUC)

    Measured: approximately 3 years

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

    Peak plasma drug concentration (Cmax)

    Measured: approximately 3 years

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

    Time to Cmax (Tmax)

    Measured: approximately 3 years

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

    Half life (T1/2)

    Measured: approximately 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Apr 2024
  2. Study start22 May 2024
  3. Primary completionApr 2031 (estimated)
  4. Study completionSep 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Model description
Phase 1a: sequential/parallel, Phase 1b: parallel
Masking
None (open label)
Enrolment
350 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06343402
Sponsor's protocol ID
TBBO8520-101
Other IDs
ONKORAS-101
Status last verified
Sep 2026
First submitted
22 Mar 2024
Last updated
3 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BBO-8520, Pembrolizumab and BBO-10203 in people with Non-small Cell Lung Cancer and Metastatic Non-Small Cell Lung Cancer, run by TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics) at 38 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 38 sites in United States, Australia, Canada, Spain, Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics) (650-405-8440, onkoras-101ct.gov@bridgebiooncology.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adverse Events (time frame: approximately 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06343402.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.

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