CI

At a glance

ClinicalIndex Comparison Record
Phase 1Recruiting· 165 target
Drug / intervention
APG-2449drug
Likely dose
Not stated in record
Key inclusion· 16
  • ✓NSCLC with ALK/ROS1 gene fusion (molecular diagnosis confirmed)
  • ✓Malignant pleural mesothelioma, esophageal cancer, or ovarian cancer (dose exploration)
  • ✓NSCLC patients progressed or intolerant to TKI therapy (expansion cohort 1)
  • ✓NSCLC with pFAK expression ≥10% (central laboratory confirmed)
Key exclusion· 11
  • ✕Receiving concurrent anti-cancer therapy or investigational therapy within 28 days prior to first dose
  • ✕TKI therapy within 8 days prior to first dose
  • ✕Unrecovered toxicities from prior therapy >Grade 1 (CTCAE v5.0)
  • ✕Difficulty swallowing or malabsorption that blocks APG-2449 intake

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03917043
NCT03917043Phase 1RecruitingHigh MomentumUpdated 12mo ago
Long Recruiting
CompareCT.gov

A Phase I Study of the Safety, Pharmacokinetic and Pharmacodynamic Properties of Orally Administered APG-2449 in Patients With Advanced Solid Tumors

Ascentage Pharma Group Inc.·interventional·Posted Apr 16, 2019·Updated Jun 18, 2025

In Brief

A Phase 1 clinical trial evaluating APG-2449 for Advanced Solid Cancer and 4 related conditions. Currently recruiting, targeting 165 participants across 9 sites.

Signals

Enrolling ahead of pace

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAdvanced Solid Cancer, Non Small Cell Lung Cancer, Esophageal Cancer, Ovarian Cancer, Malignant Pleural Mesothelioma
CountriesChina
CollaboratorsSuzhou Yasheng Pharmaceutical Co., Ltd.

Timeline

Phase 1Recruiting
202020212022202320242025202620272028
First PostedApr 16, 2019
Enrollment StartMay 27, 2019
Primary CompletionDec 1, 2027
Study CompletionJan 1, 2028
TodayJul 1, 2026
Enrollment to primary: 8.5 yearsPosted 7.2 years agoPrimary completion in 1.4 years

Interventions

APG-2449drug

Capsule, multiple dose cohorts, oral administration every day (QD) of a 28-day cycle