LY4152199 - IV
DrugAdministered by IV infusion
NCT Number: NCT07101328
The purpose of this study is to find the best dose of the drug and measure the safety and efficacy of LY4152199 in participants with previously treated B-cell malignancies. Participants will have the option to continue taking LY4152199 until the study ends.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 1
The Alfred Hospital, Melbourne, VIC, Australia
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Phase 1 Dose Escalation (Cohort A) Participants - Must have histologically confirmed relapsed/refractory B-cell malignancy.
Phase 1 Dose Optimization (Cohort B) Participants
Exclusion criteria
All Participants
Administered by IV infusion
Time frame: Cycle 1 Day 1 through Cycle 2 Day 8 (35 days)
Time frame: Baseline up to approximately 91 weeks
Time frame: Baseline up to approximately 91 weeks
Time frame: Baseline up to approximately 4 years until disease progression or start of new anti-cancer therapy
Assessed by the Investigator per disease-specific response criteria as appropriate to disease indication.
Time frame: Baseline up to approximately 4 years until disease progression or start of new anti-cancer therapy
Time between the date of first documented response (PR or better) to the date of first disease progression or death due to any cause, whichever occurs first
Time frame: Baseline up to approximately 4 years until disease progression or start of new anti-cancer therapy
Time from first dose date (or randomization date for the dose optimization cohort) to the date of first documented response (PR or better)
Time frame: Baseline up to approximately 4 years until disease progression or start of new anti-cancer therapy
Time from first dose date (or randomization date for the dose optimization cohort) to the date of first documented disease progression or death due to any cause, whichever occurs first
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
BAF_FRontier-1, A First-in-Human, Phase 1 Trial to Assess Safety, Tolerability, and Preliminary Efficacy of LY4152199, a B-cell Activation Factor Receptor (BAFF-R) T-Cell Engager Bispecific Antibody in Adult Participants With Previously Treated B-cell Malignancies
Acronym: BAF_FRontier-1
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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