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

Phase 1RecruitingNCT06343402

TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics)350 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

350

Conditions

Non-small Cell Lung Cancer Metastatic Non-Small Cell Lung Cancer NSCLC

Interventions

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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 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

Locations (32)

O'Neal Comprehensive Cancer Center at UAB

Birmingham, Alabama, United States

RECRUITING

University of California - San Diego Moores Cancer Center

La Jolla, California, United States

RECRUITING

University of California San Francisco

San Francisco, California, United States

RECRUITING

UCLA Health - Santa Monica Cancer Care

Santa Monica, California, United States

Outcomes

Primary Outcomes

Adverse Events

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