A Study of LY4584180 in Adult Participants With Previously Treated Blood Cancers
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorEli Lilly and Company
About this trial
The main purpose of this study is to evaluate safety and efficacy, and measure how much LY4584180 gets into the bloodstream and how long it takes the body to eliminate it in patients with previously treated blood cancers. For each participant, the study could last about 9 months or possibly longer including screening.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Diffuse large B-cell lymphoma - not otherwise specified
High-grade B-cell lymphoma
Diffuse large B-cell lymphoma - transformed from indolent lymphomas
Follicular large B-cell lymphoma
Disqualifiers
Has an active second cancer
Has known central nervous system (CNS) involvement by systemic lymphoma. Patients with previous treatment for CNS involvement who are neurologically stable and without evidence of active CNS disease may be eligible and enrolled if a compelling clinical rationale is provided by the Investigator and with documented Sponsor approval.
Has known Cytomegalovirus infection. Participants with negative status are eligible
Has known hepatitis B or C infection or uncontrolled HIV
Trial design
Design model
Parallel
Treatments tested in this trial
LY4584180
Drugadministered orally
Rituximab
Drugadministered through IV infusion
Treatment groups
460 Participants
are divided into 4 treatment groupsGroup A: Phase 1a-Monotherapy Dose Escalation (Cohort A1)Experimental treatment 1 intervention
Group B: Phase 1a-Monotherapy Dose Optimization (Cohort A2)Experimental treatment 1 intervention
Group C: Phase 1b-Dose Expansion-Monotherapy (Cohort B1-B3)Experimental treatment 1 intervention
Group D: Phase 1b-Dose Expansion-Combination (Cohort B4)Experimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Number of Dose-Limiting Toxicities (DLTs) and DLT-Equivalent Toxicities
Number of Dose-Limiting Toxicities (DLTs) and DLT-Equivalent Toxicities
Time frame
Baseline up to Day 282
Number of Participants with One or More Serious Adverse Events (SAEs) Considered by the Investigator to be Related to Study Drug Administration
Number of Participants with One or More Serious Adverse Events (SAEs) Considered by the Investigator to be Related to Study Drug Administration
Time frame
Baseline up to 3 Years3
To Evaluate the Preliminary Antitumor Activity of LY4584180: Objective Response Rate (ORR)
To Evaluate the Preliminary Antitumor Activity of LY4584180: Objective Response Rate (ORR)
Time frame
Baseline up to 3 YearsSecondary outcomes
1
Pharmacokinetics (PK): Maximum Serum Concentration (Cmax) of LY4584180
PK: Cmax of LY4584180
Time frame
Baseline to Day 82
PK: Area Under the Concentration (AUC) Versus Time Curve of LY4584180
PK: AUC versus time curve of LY4584180
Time frame
Baseline to Day 8Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov