NCT04771572

Study of Oral Administration of LP-118 in Patients With Relapsed or Refractory CLL, SLL, MDS, MDS/MPN, AML, CMML-2, MPN-BP, ALL, MF, NHL, RT, MM or T-PLL.

A Phase 1/1b Study Evaluating the Safety, Pharmacokinetics, and Preliminary Efficacy of LP-118 in Subjects With Relapsed or Refractory Hematological Malignancies

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Newave Pharmaceutical Inc · Industry
• Sex: All
• Age: 13 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 1, multi-center, open-label study with a dose-escalation phase (Phase 1a) and a cohort expansion phase (Phase 1b), to evaluate the safety, tolerability, and PK profile of LP-118 under a once daily oral dosing schedule in up to 100 subjects.

Detailed description

Primary objectives of the study are to assess the safety and tolerability profile, determine the maximum tolerated dose (MTD), and/or the recommended Phase 2 dose (RP2D) of LP-118 administered once daily (QD) as a single agent dosed orally in adult subjects with relapsed/refractory (low risk tumor lysis) CLL/SLL (Group 1a); relapsed/refractory MF, CMML-2, MDS/MPN, MDS-BP, MDS; AML with WBC ≤ 25 × 10\^9 cells/L (Group 1b); relapsed/refractory NHL, RT, MM, T-PLL (Group 1c); relapsed/refractory ALL (Group 1d); relapsed/refractory (intermediate and high tumor lysis risk) CLL/SLL, NHL, RT, T-PLL (Group 2); Secondary objectives of the study are to evaluate preliminary efficacy regarding the effect of LP-118 on objective response rate (ORR) using disease specific response criteria, progression-free survival (PFS), and duration of response (DOR), and overall survival (OS) in adult subjects with relapsed/refractory (low risk tumor lysis) CLL/SLL (Group 1a); relapsed/refractory MF, CMML-2, MDS/MPN, MDS-BP, MDS; AML with WBC ≤ 25 × 10\^9 cells/L (Group 1b); relapsed/refractory NHL, RT, MM, T-PLL (Group 1c); relapsed/refractory ALL (Group 1d); relapsed/refractory (intermediate and high tumor lysis risk) CLL/SLL, NHL, RT, T-PLL (Group 2);

Conditions

• Non Hodgkin Lymphoma
• Richter Transformation
• Multiple Myeloma
• T-cell-prolymphocytic Leukemia
• Acute Myeloid Leukemia
• Acute Lymphocytic Leukemia
• Myeodysplastic Syndrome
• Myelodysplastic/Myeloproliferative Neoplasm
• Myelofibrosis
• Chronic Lymphocytic Leukemia
• Small Lymphocytic Lymphoma
• Chronic Myelomonocytic Leukemia-2
• Myelodysplastic Neoplasm in Blast Phase

Interventions

Type	Name	Description
DRUG	LP-118	novel, oral, selective treatment for hematological malignancies tested through ascending dose levels

Timeline

• Start date: 2021-08-23
• Primary completion: 2025-10-01
• Completion: 2025-10-01
• First posted: 2021-02-25
• Last updated: 2024-04-24

Locations

8 sites across 1 country: United States

Regulatory

• FDA-regulated drug study