Study Summary
This trial is testing a new cancer drug, LP-108, to see if it is safe and works well against leukemia.
Eligible Conditions
- Relapsed Leukemia
- Relapsing
- Relapsed Adult Acute Myeloid Leukemia
- Chronic Myelomonocytic Leukemia
- Refractory Acute Lymphoblastic Leukemia
- Acute Myeloid Leukemia/Myelodysplastic Syndrome
Treatment Effectiveness
Phase-Based Effectiveness
Phase 1
Study Objectives
5 Primary · 7 Secondary · Reporting Duration: At Cycle 1 Day 1 (24 h PK), Cycle 1 Day 8, Cycle 1 Day 15, Cycle 1 Day 22, Cycle 2 Day 1 (24 h PK)
Day 22
The PK profile of LP-108: Area Under the Curve [AUC]
The PK profile of LP-108: Time at Maximum Concentration [Tmax]
The pharmacokinetic (PK) profile of LP-108: Maximum Plasma Concentration [Cmax]
Week 4
Duration of Response (DOR)
Event-Free Survival (EFS)
Maximum Tolerated Dose (MTD)
ORR for CMML
ORR for MDS
Objective Response Rate (ORR) for AML
Overall Survival (OS)
Progression-Free Survival (PFS)
Recommended Phase 2 dose (RP2D)
Trial Safety
Phase-Based Safety
Awards & Highlights
No Placebo Group
All patients enrolled in this trial will receive the new treatment.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
Trial Design
4 Treatment Groups
Dose Escalation Phase
1 of 4
Dose Escalation Phase: LP-108 monotherapy
1 of 4
Dose Expansion Phase: LP-108 in combination with azacitidine
1 of 4
Dose Expansion Phase
1 of 4
Experimental Treatment
36 Total Participants · 4 Treatment Groups
Primary Treatment: LP-108 · No Placebo Group · Phase 1
Dose Escalation Phase
Drug
Experimental Group · 1 Intervention: LP-108 · Intervention Types: DrugDose Escalation Phase: LP-108 monotherapy
Drug
Experimental Group · 1 Intervention: LP-108 · Intervention Types: DrugDose Expansion Phase: LP-108 in combination with azacitidine
Drug
Experimental Group · 1 Intervention: LP-108 and azacitidine · Intervention Types: DrugDose Expansion Phase
Drug
Experimental Group · 1 Intervention: LP-108 · Intervention Types: DrugTrial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: at cycle 1 day 1 (24 h pk), cycle 1 day 8, cycle 1 day 15, cycle 1 day 22, cycle 2 day 1 (24 h pk)
Who is running the clinical trial?
Newave Pharmaceutical IncLead Sponsor
3 Previous Clinical Trials
234 Total Patients Enrolled
1 Trials studying Leukemia
100 Patients Enrolled for Leukemia
Eligibility Criteria
Age 18+ · All Participants · 2 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You have a type of leukemia called AML that has either come back after treatment or has not responded to initial treatment. Alternatively, if you are an older person or someone who is not fit enough for standard treatment, the investigators may include you in Arm 2.
You may have received other medications in the same class as the study drug for Arm 2, which target a protein called BCL2, or other medications called HMA agents.