BBO-11818 in Adult Subjects With KRAS Mutant Cancer

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.

Interventions

• BBO-11818 · DRUG

  Participants will receive assigned dose of BBO-11818 orally (PO)

• Pembrolizumab · DRUG

  Patients will receive IV pembrolizumab

• Platinum chemotherapy (cisplatin or carboplatin) · DRUG

  Patients will receive IV platinum chemotherapy (cisplatin or carboplatin)

• Pemetrexed · DRUG

  Patients will receive IV pemetrexed

• Cetuximab · DRUG

  Patients will receive IV cetuximab

• mFOLFOX6 · DRUG

  Patients may receive IV mFOLFOX6

• mFOLFOX6 · DRUG

  Patients will receive IV mFOLFOX6

• BBO-10203 · DRUG

  Participants will receive BBO-10203 orally (PO)

• mFOLFIRINOX · DRUG

  Patients will receive IV mFOLFIRINOX

• Gemcitabine · DRUG

  Patients will receive IV gemcitabine

• Nab-paclitaxel · DRUG

  Patients will receive IV nab-paclitaxel

Published eligibility criteria

Verbatim from the registry. Only the site can decide how these apply to a specific patient.

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.

Sites (17)

• The Angeles Clinic and Research Institute - West Los Angeles Office, Los Angeles, California · RECRUITING
• University of California Davis, Sacramento, California · RECRUITING
• University of California San Diego Moores Cancer Center, San Diego, California · RECRUITING
• University of California San Francisco Helen Diller Family Comprehensive Cancer Center, San Francisco, California · RECRUITING
• Yale University, New Haven, Connecticut · RECRUITING
• Moffitt Cancer Center, Tampa, Florida · RECRUITING
• OSF Healthcare Cancer Institute, Peoria, Illinois · RECRUITING
• Massachusetts General Hospital, Boston, Massachusetts · RECRUITING
• NYU Langone Health, New York, New York · RECRUITING
• Columbia University Irving Medical Center, New York, New York · RECRUITING
• Vanderbilt University Medical Center, Nashville, Tennessee · RECRUITING
• Sarah Cannon Research Institute at Mary Crowley, Dallas, Texas · RECRUITING
• The University of Texas MD Anderson Cancer Center, Houston, Texas · RECRUITING
• NEXT Oncology, San Antonio, Texas · RECRUITING
• Huntsman Cancer Institute, Salt Lake City, Utah · RECRUITING
• Fred Hutchinson Cancer Center, Seattle, Washington · RECRUITING
• Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia · RECRUITING