BBO-11818 in Adult Subjects With KRAS Mutant Cancer

Volunteer for research and contribute to discoveries that may improve health care for you, your family, and your community!

a study on Lung Cancer Non-Small Cell Lung Cancer Pancreatic Ductal Adenocarcinoma Colorectal Cancer Non-Small Lung Cell Cancer KRAS G12A KRAS G12C KRAS G12D KRAS G12S KRAS G12V Solid Tumor Colorectal Tumor

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UC Davis UCSD UCSF
Dates
study started
study ends around
Principal Investigator
by Andrew Ko (ucsf)
Headshot of Andrew Ko
Andrew Ko

Description

Summary

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

Details

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.

Keywords

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, BBOT, BridgeBio Oncology Therapeutics, Phase1, Phase 1a/1b, CRC, PDAC, Metastatic Cancer, Advanced Cancer, Pembrolizumab, Cetuximab, Platinum Chemotherapy, Pemetrexed, KONQUER, KONQUER-101, mFOLFOX6, mFOLFIRINOX, Gemcitabine, Nab-paclitaxel, Non-Small-Cell Lung Carcinoma, Colorectal Neoplasms, Neoplasm Metastasis, Cisplatin, Carboplatin, 130-nm albumin-bound paclitaxel, BBO-11818, Platinum chemotherapy (cisplatin or carboplatin), BBO-10203

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • Malignancy within the last 2 years as specified in the protocol
  • Untreated brain metastases

Other inclusion/exclusion criteria are specified in the protocol.

Locations

  • University of California Davis accepting new patients
    Sacramento California 95817 United States
  • University of California San Diego Moores Cancer Center accepting new patients
    San Diego California 92037 United States
  • University of California San Francisco Helen Diller Family Comprehensive Cancer Center accepting new patients
    San Francisco California 94158 United States
  • The Angeles Clinic and Research Institute - West Los Angeles Office accepting new patients
    Los Angeles California 90025 United States

Lead Scientist at University of California Health

  • Andrew Ko (ucsf)
    Professor, Medicine, School of Medicine. Authored (or co-authored) 176 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics)
ID
NCT06917079
Phase
Phase 1 research study
Study Type
Interventional
Participants
Expecting 665 study participants
Last Updated
Contact us about this trial