Trials / Recruiting
RecruitingNCT03917043
APG-2449 in Patients With Advanced Solid Tumors
A Phase I Study of the Safety, Pharmacokinetic and Pharmacodynamic Properties of Orally Administered APG-2449 in Patients With Advanced Solid Tumors
- Status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 165 (estimated)
- Sponsor
- Ascentage Pharma Group Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Advanced Solid Cancer
- Non Small Cell Lung Cancer
- Esophageal Cancer
- Ovarian Cancer
- Malignant Pleural Mesothelioma
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | APG-2449 | Capsule, multiple dose cohorts, oral administration every day (QD) of a 28-day cycle |
Timeline
- Start date
- 2019-05-27
- Primary completion
- 2027-12-01
- Completion
- 2028-01-01
- First posted
- 2019-04-16
- Last updated
- 2025-06-18
Locations
9 sites across 1 country: China
Source: ClinicalTrials.gov record NCT03917043. Inclusion in this directory is not an endorsement.