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

ConditionsNon-small Cell Lung CancerMetastatic Non-Small Cell Lung CancerNSCLCKRAS G12CMetastatic Lung CancerAdvanced Lung Carcinoma
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorTheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics)

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Patients with a known hypersensitivity to pembrolizumab or its excipients

Trial design

Design model

Sequential

Treatments tested in this trial

  • 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

Treatment groups

350 Participants
are divided into 8 treatment groups

8

Treatment groups

See each treatment group below.

Group A: Cohort 1a - Dose Escalation/Dose Finding MonotherapyExperimental treatment 1 intervention
Group B: Cohort 1b - Dose Escalation/Dose Finding Combination TherapyExperimental treatment 2 interventions
Group C: Cohort 2a - Dose Expansion MonotherapyExperimental treatment 1 intervention
Group D: Cohort 2b - Dose Expansion Combination TherapyExperimental treatment 2 interventions
Group E: Cohort 1b Safety Lead-In - Dose Expansion Doublet Combination TherapyExperimental treatment 2 interventions
Group F: Cohort 1b - Dose Expansion Doublet Combination TherapyExperimental treatment 2 interventions
Group G: Cohort 1b Safety Lead-In - Dose Expansion Triplet Combination TherapyExperimental treatment 3 interventions
Group H: Cohort 1b - Dose Expansion Triplet Combination TherapyExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Adverse Events

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

Time frame
approximately 3 years
2

Dose-limiting toxicities (DLTs)

Number of participants with dose limiting toxicities

Time frame
approximately 3 years

Secondary outcomes

1

To evaluate preliminary antitumor activity of BBO-8520

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

Time frame
approximately 3 years
2

To evaluate preliminary antitumor activity of BBO-8520

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

Time frame
approximately 3 years
3

To evaluate preliminary antitumor activity of BBO-8520

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

Time frame
approximately 3 years
4

Overall Survival (OS)

Time frame
approximately 3 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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

Lead sponsor

Source ClinicalTrials.gov
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