BBO-11818 in Adult Subjects With KRAS Mutant Cancer

National Clinical Trial ID:: NCT06917079(opens in a new tab)
Protocol ID:: VICCPHI25051
Primary Investigator:: Cathy Eng
Phase:: I
Age Group:: Adults
Genders Eligible:: All
Drug:: 5-FU (Fluorouracil), BBO-10203, BBO-11818, Carboplatin, Cetuximab, Cetuximab, Cetuximab (Erbitux), Cetuximab (Erbitux), Cisplatin, Gemcitabine, Irinotecan, Leucovorin, Liposomal Irinotecan, Nab-Paclitaxel, Oxaliplatin, Pembrolizumab, Pemetrexed
Cancer Type:: Gastrointestinal Cancers, Lung Cancers

Overview

A first in human study to evaluate the safety and preliminary antitumor activity of BBO-11818, a pan-KRAS inhibitor, in subjects with locally advanced unresectable or metastatic KRAS mutant solid tumors.

Detailed Description

This is an open-label, multi-center, Phase 1 study designed to evaluate the safety, tolerability, pharmacokinetics, and efficacy of BBO-11818, a pan-KRAS inhibitor, alone and in combination with pembrolizumab, pembrolizumab + cis/carboplatin + pemetrexed, cetuximab, cetuximab + mFOLFOX6, BBO-10203 + mFOLFOX6, BBO-10203 +cetuximab, mFOLFIRINOX, gemcitabine + nab-paclitaxel, or BBO-10203 in subjects with locally advanced unresectable or metastatic KRAS mutant solid tumors. The study includes a dose escalation phase and a dose expansion phase.

Who Can Participate

Inclusion Criteria

Histologically documented locally advanced and unresectable or metastatic NSCLC, PDAC, CRC, or other solid tumor with KRAS G12A, G12C, G12D, G12S, or G12V mutation

Measurable disease by RECIST v1.1

Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1

Life expectancy >24 weeks

Adequate organ function

Exclusion Criteria

Malignancy within the last 2 years as specified in the protocol

Untreated brain metastases

Other inclusion/exclusion criteria are specified in the protocol.

Disclaimer

This summary is based on publicly available information from clinicaltrials.gov and is intended to help patients discuss possible trial options with their oncology care team. ClinicalTrials.gov and related public listings do not independently review or approve the safety and scientific merit of every study.

Participation decisions can be made only after review by the study team and your treating clinician.