NCT04356846

A Phase I Study of LP-108 in Patients With Relapsed or Refractory B-cell Lymphoma

A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of the Oral BCL-2 Inhibitor LP-108 in Patients With Relapsed or Refractory B-cell Lymphoma

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 74 (estimated)
• Sponsor: The First Affiliated Hospital with Nanjing Medical University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is a multi-center, open-label, single-arm phase I clinical study of LP-108. Patients with relapsed or refractory chronic lymphocytic leukemia (CLL, arm A) and other B cell non-Hodgkin's lymphoma (NHL, Arm B). Each arm has a dose escalation phase (phase Ia) and expansion phase (phase Ib). During the dose escalation phase, the primary objectives are to define dose-limiting toxicity (DLT), maximum tolerated dose (MTD), and to explore a recommended phase II dose. Dose escalation is based on the classic "3 + 3" design, while accelerated titration is applied to the initial lower doses. After the RP2Ds are determined, additional patients will be enrolled in the expansion phase to further evaluation the safety, PK and preliminary efficacy of LP-108, each therapy can enroll 12-20 subjects.

Conditions

• Non-Hodgkin Lymphoma
• Chronic Lymphocytic Leukemia

Interventions

Type	Name	Description
DRUG	LP-108 tablet	Taken orally within 30 minutes after a meal at the designated dose, once daily.

Timeline

• Start date: 2020-05-01
• Primary completion: 2023-12-01
• Completion: 2023-12-01
• First posted: 2020-04-22
• Last updated: 2023-05-01

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study