Actively Recruiting
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.
Led by Newave Pharmaceutical Inc · Updated on 2026-05-05
100
Participants Needed
8
Research Sites
294 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female participants aged 18 years or older, except for T cell and B cell ALL subjects aged 13 to 18 years with body weight 40 kg or more
- Diagnosed with relapsed or refractory hematologic malignancies including specific groups: low risk tumor lysis CLL/SLL, MF, CMML-2, MDS/MPN, AML with WBC 6 25 x 10^9 cells/L, NHL, RT, MM, T-PLL, or ALL
- Prior therapies as specified per disease group, including at least two prior therapies for many groups
- White blood cell count 6 25 x 10^9 cells/L for Group 1d ALL subjects at enrollment
- Eastern Cooperative Oncology Group (ECOG) performance score of 2 or less
- Adequate cardiac function with shortening fraction 6 40% by echocardiogram
- Adequate bone marrow, coagulation, renal, and hepatic function per lab reference ranges
- Females of childbearing potential and non-sterile males must use effective birth control during and for 90 days after study
- Females of childbearing potential must have negative pregnancy tests before and on first day of dosing
- Male participants must abstain from sperm donation from first dose until 90 days after last dose
- Ability to understand and sign informed consent form
You will not qualify if you...
- Hematopoietic stem cell transplantation within 60 days before first dose or ongoing immunosuppressive therapy post-transplant with active graft-versus-host disease
- History of other active malignancies within past 12 months that could interfere, except certain stable or treated cancers
- Receipt of anti-cancer therapies or investigational treatments within 14 days before first dose or unresolved significant side effects
- Use of strong CYP3A inhibitors, inducers, certain foods (grapefruit, star fruit) within specified washout periods before dosing
- Recent CAR-T therapy without resolution of related adverse events
- Significant medical conditions (renal, neurologic, psychiatric, cardiovascular, hepatic, etc.) that may affect participation
- Baseline QTcF interval 6 480 ms or significant heart abnormalities
- History of long QT syndrome, serious arrhythmias, heart failure, recent heart attack or stroke
- Uncontrolled infections or active HIV/hepatitis B or C infections
- Pregnant or breastfeeding females
- Inability to swallow oral medications or conditions affecting drug absorption
- Known active central nervous system involvement
- Hypersensitivity to LP-118 components
- Use of QT-prolonging drugs known to cause Torsades de Pointes without medical approval
- Major surgery within 14 days before first dose of study drug
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 8 locations
1
University of Chicago
Chicago, Illinois, United States, 60637
Actively Recruiting
2
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
3
University of North Carolina
Chapel Hill, North Carolina, United States, 27514
Actively Recruiting
4
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Actively Recruiting
5
University of Cincinnati
Cincinnati, Ohio, United States, 45229
Actively Recruiting
6
The Ohio State University
Columbus, Ohio, United States, 43210
Actively Recruiting
7
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
8
University of Utah
Salt Lake City, Utah, United States, 84112
Actively Recruiting
Research Team
A
Anna Chen, MD, PhD
CONTACT
S
Stephen Anthony, DO
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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