LY4337713
DrugAdministered IV.
NCT Number: NCT07213791
This is a study of LY4337713 in participants with certain types of cancer that is advanced or has spread. Participants must have cancer with high levels of a protein called fibroblast activation protein (FAP). The purpose of this study is to evaluate safety, side effects, and efficacy of LY4337713. In addition, this study will evaluate how much LY4337713 gets into the bloodstream, how it is broken down, and how long it takes the body to get rid of it. For each participant, the study will last about 5 years.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 1
Fudan University Zhongshan Hospital, Shanghai, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Administered IV.
Time frame: Cycle 1 (28 days)
Time frame: Baseline through imaging follow-up, up to 5 years
Per investigator assessed Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1)
Time frame: Baseline through Cycle 4 Day 4 (Cycle = 4 or 6 weeks)
Time frame: Cycle 1 Day 1 up to Cycle 2 Day 4 post dose (Cycle = 4 or 6 weeks)
Time frame: Cycle 1 Day 1 up to Cycle 2 Day 4 post dose (Cycle = 4 or 6 weeks)
Time frame: Baseline through imaging follow-up, up to 1 year
Per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Time frame: Baseline through imaging follow-up, up to 1 year
Best response recorded from the start of study treatment until the earliest of objective disease progression or start of new anticancer therapy, per RECIST v1.1.
Time frame: Baseline through imaging follow-up, up to 5 years
Time between the date of first documented response of CR or PR to the date of first disease progression, as assessed by the investigator per RECIST v1.1 or death due to any cause, whichever occurs first.
Time frame: Baseline through imaging follow-up, up to 1 year
Time from first dose date to the date of first documented response of CR or PR
Time frame: Baseline through imaging follow-up, up to 1 year
Percentage participants who achieved a BOR of CR, PR, or stable disease (SD), per RECIST v1.1
Contact information is provided by the study sponsor or research team.
Physicians interested in becoming principal investigators please contact
CONTACT
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
CONTACT
Eli Lilly and Company
Industry
A Dose Escalation and Dose Optimization Phase 1a/1b Study to Evaluate Safety, Tolerability and Dosimetry of Radioligand Therapy With LY4337713 in Adults With FAP-Positive Solid Tumors (FiREBOLT)
Acronym: FiREBOLT
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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