A Phase Ia/Ib Open-Label Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of BBO-11818 in Subjects With Advanced KRAS Mutant Cancers
Study Identifier:
TBBO11818-101
CT.gov Identifier:
EudraCT Identifier:
EU Trial (CTIS) Number:
Study Contact Information:
N/A
Recruiting
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Study 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. To evaluate BBO-11818 for the treatment of cancer
Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
Bowel (Colorectal)
Non-Small Cell Lung Cancer
Pancreas
Solid Tumor
Phase
The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
Phase I
Sex
Female & Male
Age
18+ years
Study Drug
N/A
Study Status
Indicates the current recruitment status or the expanded access status
Recruiting
Requirements information
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.
Clinical Study Information for Healthcare Providers
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Study Locations
Location
Investigator
Status
Condition(s) Treated at Site
Location
START Madrid, Spain (CIOCC)
Madrid, Spain, 28050
Investigator
Emiliano Calvo
Status
Will Be Recruiting
Condition(s) Treated at Site
Bowel (Colorectal)
Non-Small Cell Lung Cancer
Pancreas
Solid Tumor
Location
START Madrid, Spain (FJD)
Madrid, Spain, 28040
Investigator
Victor Moreno Garcia
Status
Will Be Recruiting
Condition(s) Treated at Site
Bowel (Colorectal)
Non-Small Cell Lung Cancer
Pancreas
Solid Tumor