PLM60 for Peripheral T Cell Lymphoma (PTCL)

Study Overview
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Brief Summary
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This is a Phase 1-2, randomized, multicenter, open label study of PLM60 administered via intravenous (IV) infusion in 28 day treatment cycles to adult participants with relapsed or refractory Peripheral T Cell Lymphoma (PTCL).

Detailed Description
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The study is designed to identify and characterize the safety, tolerability, efficacy, and the PK profile of PLM60 in patients with relapsed or refractory PTCL. Phase 1 will explore multiple dose levels and select a single dose level in Phase 2 to more effectively assess efficacy in the PTCL population. It is anticipated that up to approximately 30 participants will be enrolled during Phase 1. The actual number enrolled, however, will depend on the number of dose-limiting toxicity (DLT)-evaluable participants that complete the first cycle of therapy. Phase 2 will enroll up to 34 participants at the RP2D, some of whom will have been enrolled during Phase 1. Consequently, up to approximately 55 participants will be treated in the study as a whole.

Official Title
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A Randomized Phase 1-2 Study of PLM60 in Patients With Peripheral T-Cell Lymphoma

Conditions
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Peripheral T Cell Lymphoma

Intervention / Treatment
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* Drug: PLM60


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Signed informed consent prior to study-related procedures Patients with histologically confirmed relapsed or refractory PTCL, who were treated with at least 2 lines of standard therapy and for whom there is no known effective therapy. Recovered from all toxicity from prior anticancer therapy based on clinical evaluation/ judgement of the Investigator Participants must have an Eastern Cooperative Oncology Group (ECOG) performance score of 0-2. Participants who have sufficient baseline organ function by laboratory evaluations Left ventricular ejection fraction (LVEF) ≥ 50% Life expectancy ≥ 16 weeks Women of childbearing potential must have a negative pregnancy test prior to study entry, and agree to use adequate contraception from study entry through at least 3 months after the last dose of study drug A male participant must agree to use adequate contraception; or female sexual partner who uses adequate contraception measures from study entry through at least 3 months after the last dose of study drug Additional Inclusion Criteria for Phase 2: Involved lymph nodes or masses should be measurable in at least 2 perpendicular dimensions and be ≥ 1.5 cm in the longest of the perpendicular dimensions (based on Lugano Classification) Agree to undergo pretreatment bone marrow biopsy and post treatment bone marrow biopsy when required to confirm response Key Exclusion Criteria: Participants with a history of allergy to anthracyclines or liposomal drugs Prior treatment with mitoxantrone, any anthracycline, or anthacenedione Treatment with doxorubicin (with the exception of pegylated liposomal doxorubicin) with a total cumulative dose > 300 mg/m2, or epirubicin with a total cumulative dose > 500 mg/m2 Investigational treatment within 4 weeks of the start of PLM60 Prior allogeneic stem cell transplantation Current symptomatic (uncontrolled) central nervous system tumor involvement Certain types of cardiac impairment as defined in the protocol at the time of enrolment Any concurrent active malignancy or concurrent malignancy diagnosis with less than 12 months disease free interval Participants with evidence of an active infection Participants with active bleeding Participants who have had organ transplants

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 12 mg/m^2 dose group<br>Subjects will receive PLM60 at 12 mg/m^2 dose. | Drug: PLM60<br>* PLM60 will be administered via intravenous infusion in 28-day cycles for up to 7 cycles.<br>|
| Experimental: 16 mg/m^2 dose group<br>Subjects will receive PLM60 at 16 mg/m^2 dose. | Drug: PLM60<br>* PLM60 will be administered via intravenous infusion in 28-day cycles for up to 7 cycles.<br>|
| Experimental: 20 mg/m^2 dose group<br>Subjects will receive PLM60 at 20 mg/m^2 dose. | Drug: PLM60<br>* PLM60 will be administered via intravenous infusion in 28-day cycles for up to 7 cycles.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of subjects experiencing AEs and SAEs after treatment with PLM60 | Percentage of subjects experiencing AEs and SAEs, by evaluating physical examinations, vital signs, ECOG score, ECGs, ECHO or MUGA scans, and clinical laboratory findings | 8 Months | 
| Overall response rate in patients with PTCL after treatment PLM60 | Assessing the overall response rate (ORR) by Lugano Classification | 19 months |