Ascentage Pharma

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 with relapsed/refractory (R/R) hematologic malignancies.Show more

To find the recommended doses of lisaftoclax and olverembatinib that can be given in combination with decitabine to participants with advanced CML and Ph+ AML.

APG-2449 is a novel, orally active, multi-targeted tyrosine kinase inhibitor, which inhibits FAK, ALK, and ROS1 with nanomolar potencies. In preclinical studies, APG-2449 demonstrated potent antiproliferative activity in various cancer cell lines as a single agent. In combination treatment, APG-2449 enhanced anti-proliferative activities of several chemotherapeutic and targeted agents. It is indicated that APG-2449 may have a broad therapeutic potential for the treatment of human cancer as a single agent and in combination with other classes of anticancer drugs. APG-2449 is intended for the treatment of patients with advanced solid tumors. Upon completion of the Phase 1 dose escalation study to establish the maximum tolerated dose (MTD), dose-limiting toxicities (DLTs), and/or recommended phase 2 dose (RP2D), several phase Ib/II studies will be implemented accordingly.Show more

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 been treated with one-line therapy, and to evaluate the progression-free survival and clinical benefit rate of olverembatinib in patients with SDH-deficient GIST.Show more

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.

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.

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 azacitidine in newly diagnosed acute myeloid leukemia who are not eligible for standard induction chemotherapy.Show more

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.

No. Ascentage says both are under investigation in the US and not FDA approved. Both are approved in China.

Olverembatinib in China: chronic-phase and accelerated-phase chronic myeloid leukemia with the T315I mutation, and chronic-phase CML that resisted or could not tolerate earlier TKIs.

Lisaftoclax in China: adults with CLL or SLL who had at least 1 earlier treatment, including a BTK inhibitor.

Source: Ascentage Pharma 2026 interim results, August 19, 2026.

Its Phase 3 trials lead the list, and Ascentage says the GIST and MDS trials are cleared by the FDA and European regulators.

POLARIS-3: olverembatinib in SDH-deficient gastrointestinal stromal tumor after earlier treatment (NCT06640361).

GLORA-4: lisaftoclax with azacitidine in newly diagnosed higher-risk myelodysplastic syndromes (NCT06641414).

GLORA-3: lisaftoclax with azacitidine in newly diagnosed AML in adults who cannot have standard chemotherapy (NCT06389292).

Early trials: APG-3288 in relapsed blood cancers including Waldenström macroglobulinemia (NCT07424833) and APG-2449 in solid tumors including mesothelioma (NCT03917043).

Source: Ascentage Pharma 2026 interim results and ClinicalTrials.gov, checked November 2, 2026.

None that we track as of November 2026. No Ascentage Pharma label in the FDA's openFDA database matches a rare disease on Trial Friend, which usually means the company has no approved product yet or its approved drugs are for common conditions.

In development: the trials list on this page shows what Ascentage Pharma is recruiting for now, and the FDA calendar lists any application once a decision date is public.