Clinical Trial: NCT04139434
Dose-Escalation Study of Oral Administration of LP-108 as Monotherapy and in Combination With Azacitidine in Patients With Relapsed or Refractory MDS, CMML, or AML
Status:
COMPLETEDPhase:
Phase 1| Lead Sponsor: | Newave Pharmaceutical Inc |
| Information Provided By: | Newave Pharmaceutical Inc |
| Last Update Posted: | 2026-01-23 |
Study Overview
Brief Summary
A Phase 1, Multicenter, Open-label, Dose-escalation Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Clinical Activity of Orally Administered LP-108 as Monotherapy and in Combination with Azacitidine in Subjects with Relapsed or Refractory Myelodysplastic Syndromes (MDS), Chronic Myelomonocytic Leukemia (CMML), or Acute Myeloid Leukemia (AML)
Official Title
A Phase 1, Multicenter, Open-label, Dose-escalation Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Clinical Activity of Orally Administered LP-108 as Monotherapy and in Combination With Azacitidine in Subjects With Relapsed or Refractory Myelodysplastic Syndromes (MDS), Chronic Myelomonocytic Leukemia (CMML), or Acute Myeloid Leukemia (AML)
Conditions
AML/MDS, CMML, Relapse, Refractory Acute Lymphoblastic Leukemia, Relapse Leukemia, Relapsed Adult AML
Intervention / Treatment
- Drug: LP-108
- Drug: LP-108 and azacitidine
Other Study ID Numbers
- LP-108P
Start Date (Actual)
2020-07-06
Primary Completion Date (Actual)
2025-12-19
Study Completion Date (Actual)
2025-12-19
Enrollment (Actual)
32
Study Type
Interventional
Phase
Phase 1
| Lead Sponsor: | Newave Pharmaceutical Inc |
| Information Provided By: | Newave Pharmaceutical Inc |
| Last Update Posted: | 2026-01-23 |
Study Overview
Brief Summary
A Phase 1, Multicenter, Open-label, Dose-escalation Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Clinical Activity of Orally Administered LP-108 as Monotherapy and in Combination with Azacitidine in Subjects with Relapsed or Refractory Myelodysplastic Syndromes (MDS), Chronic Myelomonocytic Leukemia (CMML), or Acute Myeloid Leukemia (AML)
Official Title
A Phase 1, Multicenter, Open-label, Dose-escalation Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Clinical Activity of Orally Administered LP-108 as Monotherapy and in Combination With Azacitidine in Subjects With Relapsed or Refractory Myelodysplastic Syndromes (MDS), Chronic Myelomonocytic Leukemia (CMML), or Acute Myeloid Leukemia (AML)
Conditions
AML/MDS, CMML, Relapse, Refractory Acute Lymphoblastic Leukemia, Relapse Leukemia, Relapsed Adult AML
Intervention / Treatment
- Drug: LP-108
- Drug: LP-108 and azacitidine
Other Study ID Numbers
- LP-108P
Start Date (Actual)
2020-07-06
Primary Completion Date (Actual)
2025-12-19
Study Completion Date (Actual)
2025-12-19
Enrollment (Actual)
32
Study Type
Interventional
Phase
Phase 1