NCT04993690

A Study of LP-168 in Participants With Relapse or Refractory B-Cell Lymphoma

A Phase 1 Open-Label Dose Escalation and Expansion Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of LP-168 in Adult Patients With Relapse or Refractory B-Cell Lymphoma

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Guangzhou Lupeng Pharmaceutical Company LTD. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, multi-center Phase 1/2 study of oral LP-168 in patients with CLL/SLL and NHL who have failed or are intolerant to standard of care.

Detailed description

This study includes 2 parts: phase 1a (LP-168 monotherapy dose escalation) and phase 1b (LP-168 dose expansion). In phase 1a, patients will be enrolled using an 3+3 design. The starting dose of LP-168 in oral tablet form is 100 mg/day (e.g., 100 mg once daily \[QD\]). Once the MTD and/or RP2D is identified in phase 1a dose escalation, enrollment will continue to phase 1b dose expansion. Cycle length will be 28 days.

Conditions

• B-cell Lymphoma

Interventions

Type	Name	Description
DRUG	LP-168 tablet	Subjects to take LP-168 orally with 240mL water, without food, Once daily or twice daily

Timeline

• Start date: 2021-07-06
• Primary completion: 2026-12-31
• Completion: 2027-06-30
• First posted: 2021-08-06
• Last updated: 2025-09-23

Locations

3 sites across 1 country: China

Regulatory

• FDA-regulated drug study