Clinical trials: sponsored by Ascentage Pharma Group Inc.
Relapsed/Refractory Hematological Malignancies, Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Leukemia (CLL/SLL
A Study of APG-3288 in Relapsed/Refractory Blood Cancers
This is a Phase I, multicenter, open-label, two-stage study of APG-3288 monotherapy, aiming to determine the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of APG-3288 administered orally once daily in patients…
- Conditions
- Relapsed/Refractory Hematological Malignancies, Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Leukemia (CLL/SLL, Relapsed/Refractory Diffuse Large B-cell Lymphoma (DLBCL; Including Richter Transformation), Relapsed/Refractory Mantle Cell Lymphoma (MCL)
- Trial name
- NCT07424833
- Testing
- APG-3288
- Where
- 6 sites in United States, China
- Volunteers
- 180 people
- Sponsor
- Ascentage Pharma Group Inc.
Higher-risk Myelodysplastic Syndrome
Lisaftoclax (APG-2575) Combined With Azacytidine (AZA) in the Treatment of Patients With Higher-risk Myelodysplastic Syndrome (GLORA-4).
A global multicenter, randomized, double-blind, placebo-controlled, pivotal phase III study. To evaluate overall survival (OS) of lisaftoclax (APG-2575) combined with azacitidine (AZA) vs.
- Trial name
- NCT06641414
- Testing
- Lisaftoclax (APG-2575), Azacitidine Injection
- Where
- 155 sites in United States, Australia and 16 more
- Volunteers
- 490 people
- Sponsor
- Ascentage Pharma Group Inc.
Chronic Myeloid Leukemia, CML
Study of Olverembatinib (HQP1351) in Patients With CML-CP
Study comparing efficacy and safety of olverembatinib (investigational arm) vs. bosutinib (control arm) in patients with CML-CP (Part A).
- Conditions
- Chronic Myeloid Leukemia, CML, CML, Chronic Phase
- Trial name
- POLARIS-2 (NCT06423911)
- Testing
- olverembatinib, Bosutinib
- Where
- 163 sites in United States, Australia and 14 more
- Volunteers
- 333 people
- Sponsor
- Ascentage Pharma Group Inc.
Neuroblastoma, Solid Tumor
APG-115 Alone or in Combination With APG-2575 in Recurrent or Refractory Neuroblastoma or Solid Tumors
An open, non-randomized Phase Ib-II trial of dose-escalation and cohorts expansion to evaluate the safety, pharmacokinetic profile and initial efficacy of APG-115 alone or in combination with APG-2575 in the treatment of…
- Trial name
- NCT05701306
- Testing
- APG-115, APG-2575
- Where
- 3 sites in China
- Volunteers
- 100 people
- Sponsor
- Ascentage Pharma Group Inc.
CLL/SLL
A Study of Lisaftoclax (APG-2575) Combined With Acalabrutinib Versus Immunochemotherapy for Newly Diagnosed CLL/SLL.
This is a global, multicenter, randomized, open-label, Phase III confirmatory study to investigate the efficacy and safety of Lisaftoclax (APG-2575) in combination with Acalabrutinib in patients with newly diagnosed CLL/SLL.
- Trial name
- NCT06319456
- Testing
- Lisaftoclax (APG-2575), Acalabrutinib, Fludarabine
- Where
- 10 sites in China
- Volunteers
- 344 people
- Sponsor
- Ascentage Pharma Group Inc.
Advanced Solid Cancer, Non Small Cell Lung Cancer
APG-2449 in Patients With Advanced Solid Tumors
APG-2449 is a novel, orally active, multi-targeted tyrosine kinase inhibitor, which inhibits FAK, ALK, and ROS1 with nanomolar potencies.
- Conditions
- Advanced Solid Cancer, Non Small Cell Lung Cancer, Esophageal Cancer, Ovarian Cancer
- Trial name
- NCT03917043
- Testing
- APG-2449
- Where
- 9 sites in China
- Volunteers
- 165 people
- Sponsor
- Ascentage Pharma Group Inc.
GIST
A Study of Olverembatinib in SDH-deficient GIST.
An international multicenter, open, single-arm pivotal registration phase III study to determine the efficacy and safety of olverembatinib in patients with SDH-deficient gastrointestinal stromal tumor (GIST) who have previously…
- Trial name
- NCT06640361
- Testing
- Olverembatinib
- Where
- China
- Volunteers
- 40 people
- Sponsor
- Ascentage Pharma Group Inc.
Platinum-resistant Recurrent Ovarian Cancer, Advanced Solid Tumor
APG-2449 Monotherapy or in Combination With PLD in Patients With Platinum-resistant Recurrent OC or Advanced ST
An open, multicenter, dose-exploring Phase I trial include Part A and Part B to evaluate the safety, tolerability and efficacy of APG-2449.
- Trial name
- NCT06687070
- Testing
- APG -2449, PLD
- Where
- China
- Volunteers
- 90 people
- Sponsor
- Ascentage Pharma Group Inc.
CLL/SLL
Global Trial in APG2575 for Patients With CLL/SLL
This is a global multicenter, open label, randomized, registrational phase III study to investigate the efficacy and safety of lisaftoclax in combination with BTK inhibitors in CLL/SLL patients who previously treated with BTK…
- Trial name
- NCT06104566
- Testing
- lisaftoclax +BTK inhibitor, BTK inhibitor
- Where
- 135 sites in United States, Australia and 17 more
- Volunteers
- 400 people
- Sponsor
- Ascentage Pharma Group Inc.
Chronic Lymphocytic Leukemia, Non Hodgkin Lymphoma
A Study to Evaluate the Safety,PK and PD of APG-2575 in Patients With Hematologic Malignancies
The purpose of this study is to assess the safety, tolerability, pharmacokinetic and pharmacodynamic properties of APG-2575 in patients with relapse or refractory chronic lymphocytic leukemia and non-hodgkin's lymphoma.
- Trial name
- NCT03913949
- Testing
- APG-2575
- Where
- 5 sites in China
- Volunteers
- 74 people
- Sponsor
- Ascentage Pharma Group Inc.
Ph+ ALL, Leukemia, Lymphoblastic, Acute, Philadelphia-Positive
A Study of Olverembatinib in Patients With Newly Diagnosed Ph+ ALL (POLARIS-1)
A global multicenter, open-label, randomized and registrational Phase 3 study to evaluate efficacy and safety of olverembatinib combined with chemotherapy versus investigator's choice of tyrosine kinase inhibitor (TKI) combined…
- Trial name
- NCT06051409
- Testing
- Olverembatinib, Investigator's choice of TKI
- Where
- 90 sites in United States, Australia and 10 more
- Volunteers
- 350 people
- Sponsor
- Ascentage Pharma Group Inc.
Relapsed/Refractory Acute Myeloid Leukaemia, Myeloid Malignancy
Study of Lisaftoclax (APG-2575) Single Agent and Combination With Therapy in Patients Relapsed/Refractory AML
The purpose of this study is to assess the safety, pharmacokinetic profile of Lisaftoclax (APG-2575) single agent and in combination with HHT/AZA in patients with relapsed/refractory AML and related myeloid malignancies.
- Trial name
- NCT04501120
- Testing
- Lisaftoclax (APG-2575), Reduced-dose HHT, standard-dose HHT
- Where
- 12 sites in China
- Volunteers
- 682 people
- Sponsor
- Ascentage Pharma Group Inc.
Anemia
A Study to Evaluate the Safety, Pharmacokinetics and Preliminary Efficacy of APG-5918.
The purpose of the study is to evaluate the safety, tolerability, pharmacokinetics and efficacy of APG-5918 in Healthy Subjects or Anemic Patients.
- Trial name
- NCT05773586
- Testing
- APG-5918
- Where
- 2 sites in China
- Volunteers
- 105 people, healthy volunteers welcome
- Sponsor
- Ascentage Pharma Group Inc.
Gastrointestinal Stromal Tumor (GIST), Solid Tumor, Adult
A Study of HQP1351 in Patients With GIST or Other Solid Tumors
This study is a Multi-center, Open-label Phase 1 Study to Determine the Recommend Phase 2 Dose (RP2D) and Evaluate PK/PD and preliminary Efficacy of HQP1351 in Patients With GIST or Other Solid Tumors.
- Trial name
- NCT03594422
- Testing
- HQP1351
- Where
- 6 sites in China
- Volunteers
- 100 people
- Sponsor
- Ascentage Pharma Group Inc.
Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
Study of APG-2575 in Patients With Relapsed/Refractory CLL/SLL
The purpose of this study is to assess the efficacy and safety of APG-2575 single agent in patients with relapsed/refractory CLL/SLL.
- Trial name
- NCT05147467
- Testing
- APG2575
- Where
- 11 sites in China
- Volunteers
- 75 people
- Sponsor
- Ascentage Pharma Group Inc.
Advanced Pancreatic Cancer
APG-1387 Plus Chemotherapy in Advanced Pancreatic Adenocarcinoma
This study is a two stage study consisting of a dose escalation phase Ib and a phase II study which include subjects with previously-treated, advanced pancreatic adenocarcinoma.
- Trial name
- NCT04643405
- Testing
- APG-1387 for Injection, Gemcitabine, Nab paclitaxel
- Where
- China
- Volunteers
- 21 people
- Sponsor
- Ascentage Pharma Group Inc.
Advanced Solid Tumor
Dose-escalation Study of APG-1387 and Toripalimab in Solid Tumors
An ascending dose study in patients with solid tumors to evaluate the safety, tolerability, pharmacodynamics and efficacy of APG-1387 in combination with toripalimab. A phase II study of 3 cohorts will be included.
- Trial name
- NCT04284488
- Testing
- APG-1387 for Injection, Toripalimab
- Where
- 3 sites in China
- Volunteers
- 40 people
- Sponsor
- Ascentage Pharma Group Inc.
Pharmacokinetic, Olverembatinib
Pharmacokinetics of Olverembatinib in Participants With Hepatic Impairment
This is a non-randomized, open-label, parallel, single-dose study to evaluate the pharmacokinetic profile of olverembatinib in participants with normal or impaired liver function.
- Trial name
- NCT07282093
- Testing
- Olverembatinib 20mg
- Where
- China
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Ascentage Pharma Group Inc.
SLE
A Study of APG-2575 in Patients With Mild-to-moderate Systemic Lupus Erythematosus.
To evaluate the safety, tolerability, pharmacokinetics and pharmacokinetics of multi-dose APG-2575 in mild-to-moderate systemic lupus erythematosus (SLE).
- Trial name
- NCT06182969
- Testing
- APG-2575
- Where
- China
- Volunteers
- 40 people
- Sponsor
- Ascentage Pharma Group Inc.
Acute Myeloid Leukemia
A Pivotal Study of APG-2575 (Lisaftoclax) Combined With Azacitidine in the Treatment of Acute Myeloid Leukemia
A global, multicenter, randomized, double-blind, placebo-controlled, phase III pivotal registration study, to evaluate the efficacy of APG-2575 (Lisaftoclax) combined with azacitidine (AZA) versus placebo combined with…
- Trial name
- NCT06389292
- Testing
- APG-2575(Lisaftoclax ), Azacitidine Injection
- Where
- 6 sites in China, Russia
- Volunteers
- 486 people
- Sponsor
- Ascentage Pharma Group Inc.