A Phase 1/1b Study Evaluating the Safety, Pharmacokinetics, and Preliminary Efficacy of LP-118 in Subjects With Relapsed or Refractory Hematological Malignancies
Newave Pharmaceutical Inc
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.
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 (G…
Eligibility
- Age range
- 13+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Male or female subjects, ≥ 18 years of age at the time of Screening with the following exception as outlined below: -For T cell and B cell ALL subjects with age between 13 - 18 years, their body weight shall be ≥ 40 kg. 2. Eligible subject must have an advanced hematologic malignancy including: Group 1: Group 1a * Relapsed or refractory low risk tumor lysis CLL/SLL subjects (ALC \< 25 x 109 cells/L and all lymph nodes \< 5 cm) who have received at least two prior therapies. Subjects may also have slowly progressed on irreversible BTK inhibitors while on t…
Interventions
- DrugLP-118
novel, oral, selective treatment for hematological malignancies tested through ascending dose levels
Locations (8)
- University of ChicagoChicago, Illinois
- Dana Farber Cancer InstituteBoston, Massachusetts
- University of North CarolinaChapel Hill, North Carolina
- Cincinnati Children's Hospital Medical CenterCincinnati, Ohio
- University of CincinnatiCincinnati, Ohio
- The Ohio State UniversityColumbus, Ohio