Clinical trials: sponsored by Ascentage Pharma Group Inc.
Leukemia, Myeloid, Chronic, Myeloid Leukemia
Study of HQP1351 in Subjects With Refractory CML and Ph+ ALL
A multi-center, open-label, randomized, phase Ib study to evaluate the pharmacokinetics (PK) of HQP1351 and to determine the recommended phase 2 dose (RP2D) of HQP1351 in subjects with CML chronic phase (CP), accelerated phase…
- Conditions
- Leukemia, Myeloid, Chronic, Myeloid Leukemia, Chronic Myeloid Leukemia, Philadelphia Positive Acute Lymphoblastic Leukemia
- Trial name
- NCT04260022
- Testing
- Ascentage Pharma HQP1351 bioavailable inhibitor, Blinatumomab
- Where
- 9 sites in United States, Canada
- Volunteers
- 242 people
- Sponsor
- Ascentage Pharma Group Inc.
T-Prolymphocytic Leukemia, Non-Hodgkins Lymphoma
A Study Evaluating APG-115 as a Single Agent or in Combination With APG-2575 in Subjects With R/R T-PLL and NHL
The goal of this study is to evaluate the pharmacokinetics (PK), safety, and efficacy of APG-115 as a single agent or in combination with APG-2575 in patients with T-PLL and NHL.
- Trial name
- NCT04496349
- Testing
- APG-115, APG-2575
- Where
- United States
- Volunteers
- 78 people
- Sponsor
- Ascentage Pharma Group Inc.
EGFR Positive Non-small Cell Lung Cancer
A Study of APG-1252 Plus Osimertinib(AZD9291) in EGFR TKI Resistant NSCLC Patients
There are unmet medical needs in patients who resist to EGFR TKIs, especially to osimertinib; APG-1252 shows synergy with osimertinib in both osimertinib treatment naïve and resistant cell lines.
- Trial name
- NCT04001777
- Testing
- APG-1252, Osimertinib Mesylate Tablets
- Where
- 4 sites in China
- Volunteers
- 80 people
- Sponsor
- Ascentage Pharma Group Inc.
Waldenstrom Macroglobulinemia
APG-2575 Single Agent or in Combination With Ibrutinib or Rituximab in Patients With Waldenström Macroglobulinemia
Phase Ib/II study of safety, tolerability, efficacy and PK of APG-2575 as a single agent or in combination with other therapeutic agents including ibrutinib or rituximab.
- Trial name
- MAPLE-1 (NCT04260217)
- Testing
- APG2575 400 mg, APG2575 600 mg, APG2575 800 mg
- Where
- 14 sites in United States, Australia and 1 more
- Volunteers
- 46 people
- Sponsor
- Ascentage Pharma Group Inc.
Unresectable or Metastatic Melanoma or Advanced Solid Tumors, Melanoma
A Study of APG-115 in as a Monotherapy or Combination With Pembrolizumab in Patients With Metastatic Melanomas or Advanced Solid Tumors
This study aims to assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of APG-115, an MDM2 inhibitor, either alone or in combination with pembrolizumab, a programmed cell death protein-1 (PD-1) inhibitor…
- Conditions
- Unresectable or Metastatic Melanoma or Advanced Solid Tumors, Melanoma, Uveal Melanoma, P53 Mutation
- Trial name
- NCT03611868
- Testing
- Phase 1b: APG-115+pembrolizumab
- Where
- 21 sites in United States, Australia
- Volunteers
- 230 people
- Sponsor
- Ascentage Pharma Group Inc.
Neuroendocrine Tumors
A Study of Pelcitoclax (APG-1252) in Patients With Neuroendocrine Tumors
APG-1252 is a highly potent Bcl-2 family protein inhibitor, a promising drug candidate which shown high binding affinities to Bcl-2, Bcl-xL and Bcl-w.
- Trial name
- NCT04893759
- Testing
- Pelcitoclax
- Where
- 3 sites in China
- Volunteers
- 2 people
- Sponsor
- Ascentage Pharma Group Inc.
Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
Study of APG2575 Single Agent and Combination Therapy in Patients With Relapsed/Refractory CLL/SLL
The purpose of this study is to assess the safety, pharmacokinetic, pharmacodynamic and efficacy of APG-2575 single agent and in combination with other therapeutic agents in patients with relapsed/refractory CLL/SLL.
- Trial name
- NCT04494503
- Testing
- APG-2575, Rituximab, Ibrutinib
- Where
- 18 sites in China
- Volunteers
- 123 people
- Sponsor
- Ascentage Pharma Group Inc.
CLL/SLL
Study of APG-2575 as a Single Agent or in Combination With Other Therapeutic Agents for CLL/SLL
Assess the safety and tolerability, identify dose-limiting toxicities (DLT) and determine the maximum tolerated dose (MTD) / recommended phase 2 dose (RP2D) of lisaftoclax.
- Trial name
- NCT04215809
- Testing
- Lisaftoclax
- Where
- 9 sites in United States, Australia
- Volunteers
- 144 people
- Sponsor
- Ascentage Pharma Group Inc.
Chronic Myeloid Leukemia, Chronic Phase
A Pivotal Study of HQP1351 in Patients With Chronic Myeloid Leukemia in Chronic Phase
The purpose of this study is to evaluate the efficacy of HQP1351 in patients with chronic myeloid leukemia in chronic phase (CML-CP) who are resistant and/or intolerant to first- and second-generation tyrosine kinase inhibitors.
- Trial name
- NCT04126681
- Testing
- HQP1351, Hydroxyurea or Interferon-based therapy, Homoharringtonine
- Where
- 22 sites in China
- Volunteers
- 144 people
- Sponsor
- Ascentage Pharma Group Inc.
Liposarcoma, Advanced Solid Tumor
APG-115 in Combination With PD-1 Inhibitor in Patients With Advanced Liposarcoma or Advanced Solid Tumors
Part 1 is a phase Ib standard "3 + 3" design, will be employed to determine the MTD of APG-115 by assessing the DLT of APG-115 in combination with PD-1 inhibitor(toripalimab) in advanced solid tumors.
- Trial name
- NCT04785196
- Testing
- APG-115, Toripalimab
- Where
- 3 sites in China
- Volunteers
- 95 people
- Sponsor
- Ascentage Pharma Group Inc.
Acute Myeloid Leukemia (AML), Myelodysplastic Syndromes (MDS)
A Phase Ib Study of APG-115 Single Agent or in Combination With Azacitidine or Cytarabine in Patients With AML and MDS.
Acute myeloid leukemia is a malignant disorder characterized by the rapid, uncontrolled proliferation of malignant clonal hematopoietic stem cells that accumulate as immature, undifferentiated cells (blasts) in the bone marrow…
- Trial name
- NCT04275518
- Testing
- APG-115, Azacitidine, Cytarabine
- Where
- 14 sites in China
- Volunteers
- 102 people
- Sponsor
- Ascentage Pharma Group Inc.
Breast Cancer, Solid Tumor, Adult
A Study to Investigate the Safety, Tolerability, of APG-2575 as a Single Agent or in Combination for Breast Cancer
This is a multi-center, open-label, phase Ib/II study of APG-2575 as a single agent in patients with advanced solid tumors or in combination with anti-cancer agents such as CDK 4/6 inhibitor palbociclib in patients with ER+/HER2…
- Trial name
- NCT04946864
- Testing
- APG-2575, Palbociclib
- Where
- 7 sites in United States, China
- Volunteers
- 65 people
- Sponsor
- Ascentage Pharma Group Inc.
Hematologic Malignancies
APG-2575 Study of Safety, Tolerability ,PK/PD in Patients With Hematologic Malignancies
This is a multi-center, single-agent, open-label, Phase I study of APG-2575. The study consists of the dose escalation stage and the dose expansion stage.
- Trial name
- NCT03537482
- Testing
- APG-2575
- Where
- 5 sites in United States, Australia
- Volunteers
- 90 people
- Sponsor
- Ascentage Pharma Group Inc.
Named Patient Program for Olverembatinib (HQP1351)
This program will allow eligible patients access to Ascentage Pharma's novel drug candidate Olverembatinib (approved in China) on a named patient basis in over 100 countries ( with the exception of the USA and China) and regions…
- Trial name
- NCT05594758
- Testing
- Olverembatinib
- Sponsor
- Ascentage Pharma Group Inc.
AML, Acute Myeloid Leukemia
A Study of APG-115 Alone or Combined With Azacitidine in Patients With AML, CMML, or MDS
This is a two Part study in patients with relapsed/refractory acute myeloid leukemia (AML), chronic myelomonocytic leukemia (CMML), or high risk myelodysplastic syndrome (MDS) that will initially evaluate the safety and…
- Conditions
- AML, Acute Myeloid Leukemia, Chronic Myelomonocytic Leukemia, CMML
- Trial name
- NCT04358393
- Testing
- APG-115, 5-azacitidine
- Where
- 8 sites in United States
- Volunteers
- 69 people
- Sponsor
- Ascentage Pharma Group Inc.
NHL, Adult
APG-1252 Monotherapy or in Combination With Other Therapeutic Agent in Subjects With Relapsed or Refractory Non-Hodgkin Lymphoma
The purpose of this study is to assess the safety, pharmacokinetic, pharmacodynamic and efficacy of APG-1252 single agent and in combination with other therapeutic agent in patients with NHL.
- Trial name
- NCT05186012
- Testing
- APG-1252, Chidamide
- Where
- 4 sites in China
- Volunteers
- 51 people
- Sponsor
- Ascentage Pharma Group Inc.
Pharmacokinetics
The Absorption, Metabolism and Excretion of [14C]APG-2575 in Healthy Subjects
This study is a single-center, open-label, single-dose clinical pharmacokinetic study. The purpose of this study is to investigate the absorption properties, as well as to evaluate the mass balance and elucidate the pathways of…
- Trial name
- NCT05517616
- Testing
- [14C ]APG-2575
- Where
- China
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Ascentage Pharma Group Inc.
AML, Adult
A Study of APG-2575 in Combination With Azacitidine in Patients With Acute Myeloid Leukemia (AML)
This is a Phase Ib/II, open-label, multi-center study evaluating the safety, tolerability, efficacy and PK of APG-2575 in combination with Azacitidine in the patients with AML/MPAL or MDS/CMML.
- Trial name
- NCT04964518
- Testing
- APG 2575 ramp up arm
- Where
- 9 sites in United States, Australia
- Volunteers
- 24 people
- Sponsor
- Ascentage Pharma Group Inc.
Multiple Myeloma, Amyloidosis
APG-2575 in Combination With Novel Therapeutic Regimens in Subjects With Relapsed or Refractory Multiple Myeloma
This is a Phase Ib/II, open-label, multi-center study evaluating the safety, tolerability, efficacy, and PK/ Pharmacodynamics of APG-2575 in combination with Pd/DRd in patients with relapsed/refractory (RR) multiple myeloma (MM).
- Trial name
- NCT04942067
- Testing
- APG-2575+ Pd, APG-2575 + DRd
- Where
- 3 sites in United States
- Volunteers
- 108 people
- Sponsor
- Ascentage Pharma Group Inc.
Chronic Myeloid Leukemia, Chronic Phase
A Pivotal Study of HQP1351 in Patients of Chronic Myeloid Leukemia in Chronic Phase With T315I Mutation
The purpose of this study is to evaluate the efficacy of HQP1351 in patients with chronic myeloid leukemia in chronic phase (CML-CP) harboring T315I mutation.
- Trial name
- NCT03883087
- Testing
- HQP1351
- Where
- 10 sites in China
- Volunteers
- 41 people
- Sponsor
- Ascentage Pharma Group Inc.