Safety and Efficacy Study of a Dual PI3K Delta/Gamma Inhibitor in T-cell Lymphoma

A Phase I/Ib, Dose Escalation Study to Evaluate Safety and Efficacy of RP6530, a Dual PI3K δ/γ Inhibitor, in Patients With Relapsed or Refractory T-cell Lymphoma

The purpose of this study is to evaluate the safety, PK and efficacy of RP6530, a dual PI3K delta/gamma inhibitor in patients with relapsed and refractory T-cell Lymphoma.

Safety: Treatment-Emergent AE; Treatment-Related AE, SAE and Clinical significant AE; Dose Limiting Toxicities (DLT). 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.

Inclusion Criteria:

• Histologically confirmed T cell Non-Hodgkin Lymphoma (T-NHL)
• Refractory to or relapsed after at least 1 prior treatment line.
• ECOG performance status ≤2
• Patients must be ≥18 years of age
• Able to give a written informed consent.

Exclusion Criteria:

• Any cancer therapy in the last 3 weeks or limited palliative radiation <2 weeks
• Patients with HBV, HCV or HIV infection
• Previous therapy with GS-1101 (CAL-101, Idelalisib), IPI-145 (Duvelisib), TGR-1202 or any drug that specifically inhibits PI3K/ mTOR (including temsirolimus, everolimus), AKT or BTK Inhibitor (including Ibrutinib) in last 6 months
• Patients on immunosuppressive therapy including systemic corticosteroids.
• Patients with known history of liver disorders.
• Patients with uncontrolled Diabetes Type I or Type II
• Any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study.
• Women who are pregnant or lactating.