Open-label Study of BBO-11818 in Adult Subjects With KRAS Mutant Cancer

Description

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.

Conditions

Non-Small Cell Lung Cancer, NSCLC, PDAC - Pancreatic Ductal Adenocarcinoma, CRC (Colorectal Cancer), Metastatic Non-Small Lung Cell Cancer, Metastatic Colorectal Cancer (CRC), KRAS G12A, KRAS G12C, KRAS G12D, KRAS G12S, KRAS G12V, Metastatic Pancreatic Ductal Adenocarcinoma, Advanced Lung Carcinoma, Solid Tumor, Adult

Study Overview

Study Details

Study 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.

A Phase 1a/1b Open-Label Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of BBO-11818 in Subjects With Advanced KRAS Mutant Cancers

Open-label Study of BBO-11818 in Adult Subjects With KRAS Mutant Cancer

Condition
Non-Small Cell Lung Cancer
Intervention / Treatment

-

Contacts and Locations

Salt Lake City

Huntsman Cancer Institute, Salt Lake City, Utah, United States, 84112

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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, or KRAS-amplification
  • * Measurable disease by RECIST v1.1
  • * Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1
  • * Malignancy within the last 2 years as specified in the protocol
  • * Untreated brain metastases
  • * Known hypersensitivity to BBO-11818 or its excipients

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

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

Study Record Dates

2029-09