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A Study of LY4152199 in Participants With Previously Treated B-cell Malignancies (BAF_FRontier-1 )

ConditionsLymphoma, Non-HodgkinB-cell LymphomaLymphoma, Large B-Cell, DiffuseLymphoma, FollicularLymphoma, B-cell Marginal ZoneWaldenstrom MacroglobulinemiaLymphoma, Mantle Cell
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorEli Lilly and Company

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Must have a diagnosis of either follicular lymphoma or diffuse large B-cell lymphoma.

Must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

Estimated life expectancy of greater than or equal to (≥)12 weeks as judged by the Investigator.

Participants with lymphoma must have at least 1 bi-dimensionally measurable lesion or in the absence of measurable lymphadenopathy, documentation of bone marrow involvement.

Disqualifiers

Known or suspected peripheral blood involvement by malignant cells with an absolute lymphocyte count of greater than or equal to (≥) 5000 cells per microliter (μL).

Known or suspected central nervous system (CNS) involvement by systemic lymphoma.

Current or history of CNS disease, such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease

Any unresolved toxicities from prior therapy greater than National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 Grade 2 at the time of starting trial treatment except for alopecia.

Trial design

Design model

Sequential

Treatments tested in this trial

  • LY4152199 - IV

    Drug

    Administered by IV infusion

Treatment groups

215 Participants
are divided into 3 treatment groups
Group A: Phase 1: Dose Escalation (Cohort A) - DLBCL and FLExperimental treatment 1 intervention
Group B: Phase 1: Dose Optimization (Cohort B1) - DLBCLExperimental treatment 1 intervention
Group C: Phase 1: Dose Optimization (Cohort B2) - FLExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Phase 1 - Number of Participants with Dose Limiting Toxicities (DLT) of LY4152199

Time frame
Cycle 1 Day 1 through Cycle 2 Day 8 (35 days)

Secondary outcomes

1

Phase 1 - Pharmacokinetics (PK): Area under the Concentration versus Time Curve (AUC) of LY4152199

Time frame
Baseline up to approximately 91 weeks
2

Phase 1- PK: Maximum drug Concentration (Cmax) of LY4152199

Time frame
Baseline up to approximately 91 weeks
3

Phase 1 - Overall Response Rate (ORR): Percentage of Participants with Best Overall Response (BOR) of Partial Response (PR) or Better.

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
4

Phase 1 - Duration of Response (DOR)

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Eli Lilly and Company

Lead sponsor

Source ClinicalTrials.gov
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