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

TheRas, Inc., d/b/a BridgeBio Oncology Therapeutics

Status and phase: Enrolling; Phase 1

Conditions: Metastatic Non-Small Cell Lung Cancer; Advanced Lung Carcinoma; Non-small Cell Lung Cancer; KRAS G12C; Metastatic Lung Cancer; NSCLC

Treatments: Drug: BBO-8520; Drug: Pembrolizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT06343402

ONKORAS-101 (Other Identifier)

TBBO8520-101

Details and patient eligibility

About

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 in subjects with locally advanced and unresectable or metastatic non-small cell lung cancer with a KRAS (Kirsten rat sarcoma) G12C mutation.

Full 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 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

Enrollment: 250 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 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 design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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250 participants in 4 patient groups

Cohort 1a - Dose Escalation/Dose Finding Monotherapy

Experimental group

Description:

Participants enrolled in this cohort will receive BBO-8520 (different dose levels will be evaluated) once a day (QD) as monotherapy

Treatment:

Drug: BBO-8520

Cohort 1b - Dose Escalation/Dose Finding Combination Therapy

Experimental group

Description:

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)

Treatment:

Drug: Pembrolizumab

Drug: BBO-8520

Cohort 2a - Dose Expansion Monotherapy

Experimental group

Description:

Participants enrolled in this cohort will receive BBO-8520 once a day (QD) as monotherapy

Treatment:

Drug: BBO-8520

Cohort 2b - Dose Expansion Combination Therapy

Experimental group

Description:

Participants enrolled in this cohort will receive BBO-8520 once a day (QD) in combination with pembrolizumab infusion (IV)

Treatment:

Drug: Pembrolizumab

Drug: BBO-8520