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

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

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

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).

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.