Study of BBO-8520 in Adult Subjects with KRASG12C Non-small Cell Lung and Colorectal Cancer

About

Brief Summary

A first in human study to evaluate the safety, tolerability, and pharmacokinetics (PK) of BBO-8520, a KRAS G12C (ON) inhibitor, single agent and in combination with pembrolizumab in patients with advanced non-small cell lung cancer and colorectal cancer

Primary Purpose

Treatment

Study Type

Interventional

Phase

Phase 1

Eligibility

Gender

All

Healthy Volunteers

No

Minimum Age

18 Years

Maximum Age

N/A

Inclusion Criteria:

Histologically documented locally advanced or metastatic non-small cell lung cancer or colorectal 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 2a 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