RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood 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.

Official Title

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

Quick Facts

Study Start:2025-03-31
Study Completion:2029-09
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06917079

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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
  2. * Measurable disease by RECIST v1.1
  3. * Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1
  1. * Malignancy within the last 2 years as specified in the protocol
  2. * Untreated brain metastases
  3. * Known hypersensitivity to BBO-11818 or its excipients

Contacts and Locations

Study Contact

TheRas, Inc. d/b/a BridgeBio Oncology Therapeutics
CONTACT
650-391-9740
tbbo11818-101ct.gov@bridgebiooncology.com

Study Locations (Sites)

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

Collaborators and Investigators

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03-31
Study Completion Date2029-09

Study Record Updates

Study Start Date2025-03-31
Study Completion Date2029-09

Terms related to this study

Keywords Provided by Researchers

  • BBOT
  • BridgeBio Oncology Therapeutics
  • Phase1
  • Phase 1a/1b
  • NSCLC
  • CRC
  • PDAC
  • Metastatic Cancer
  • Advanced Cancer
  • Pembrolizumab
  • Cetuximab
  • Platinum Chemotherapy
  • Pemetrexed

Additional Relevant MeSH Terms

  • 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