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)250 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 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 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

250

Conditions

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

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 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 (27)

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

RECRUITING

Yale Cancer Center

New Haven, Connecticut, United States

Outcomes

Primary Outcomes

Adverse Events

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