Safety and Efficacy Study of RP4010, in Patients With Relapsed or Refractory Lymphomas

Study Overview
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Brief Summary
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A Phase I/Ib, Study to Evaluate Safety and Efficacy of RP4010, in Patients with Relapsed or Refractory Lymphomas

Detailed Description
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Safety: Treatment-Emergent Adverse Events (AE); Treatment related AE, Serious Adverse Events (SAE) and Clinical significant AE; Dose Limiting Toxicities (DLT). Pharmacokinetics (PK): Peak Plasma Concentration (Cmax), Area under the plasma concentration versus time curve (AUC), Time of Maximum Concentration Observed (Tmax). Efficacy: Overall Response Rate (ORR), Progression Free Survival (PFS); Overall Survival (OS) and duration of Response (DoR).

Official Title
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A Phase I/Ib, Study to Evaluate Safety and Efficacy of RP4010, in Patients With Relapsed or Refractory Lymphomas

Conditions
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Lymphoma

Intervention / Treatment
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* Drug: RP4010


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Refractory to or relapsed after at least 1 prior treatment line. Eastern Cooperative Oncology Group (ECOG) performance status ≤2 Patients must be ≥18 years of age Able to give a written informed consent. Exclusion Criteria: Patients receiving cancer therapy within 3 weeks prior to Cycle1 Day1 (C1D1). Patients with active Hepatitis B virus (HBV), Hepatitis C virus (HCV) or Human immune deficiency virus (HIV) infection Patients who received Allo-Stem cell Transplantation(Allo-SCT) within 12 months. Patients with graft versus-host disease (GVHD) Subjects who have received drugs that directly or indirectly inhibit calcineurin or Nuclear Factor of activated T cells (NFAT) activity . Patient with symptomatic, or history of documented congestive heart failure (NY Heart Association functional classification III-IV); Patient with Frederica's (QTcF) formulas (QTcF) ≥450 msec; Patient with angina not well-controlled by medication; Women who are pregnant or lactating.

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single arm<br>RP4010 to be administered | Drug: RP4010<br>* Escalating doses starting at 25 mg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Tolerated Dose (MTD) Determination | To determine the maximum tolerated dose of RP4010 in patients with Relapsed or Refractory Non-Hodgkin Lymphoma | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Plasma Concentration (Cmax). | To assess the Maximum Plasma Concentration (Cmax). | 24 hrs | 
| Area under the curve (AUC) | To assess the Area under the plasma concentration versus time curve (AUC) | 24 hrs | 
| Anti-tumor activity-Overall response rate (ORR) | To assess the anti-tumor activity of RP4010 as determined by overall response rate (ORR) | 2 months |