RecruitingPhase 1NCT03917043

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

Sponsor

Ascentage Pharma Group Inc.

Enrollment

165 participants

Start Date

May 27, 2019

Study Type

INTERVENTIONAL

Conditions

Advanced Solid Cancer

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a new drug called APG-2449, which targets specific gene mutations (ALK, ROS1, and FAK) that drive certain lung cancers and other solid tumors, in patients whose cancer has progressed on standard targeted treatments. **You may be eligible if...** - You have non-small cell lung cancer with an ALK or ROS1 gene mutation, and your cancer has progressed on or you cannot tolerate prior targeted therapy - You have mesothelioma, esophageal cancer, or ovarian cancer (for the early dose-finding phase) - You are in adequate overall health **You may NOT be eligible if...** - You do not have one of the qualifying cancer types or gene mutations - Your overall health status does not meet the study requirements Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAPG-2449

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

Locations(9)

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Fujian Medical University Union Hospital

Fuzhou, Fujian, China

Fujian Cancer Hospital

Fuzhou, Fujian, China

Sun-Yat Sen University Cancer Center

Guangzhou, Guangdong, China

The First affiliated hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

Henan Provincial Oncology Hospital

Zhengzhou, Henan, China

Union Hospital medical college Huazhong University of Science and Technology

Wuhan, Hubei, China

Hunan Provincial Oncology Hospital

Changsha, Hunan, China

Zhejiang Provincial Oncology Hospital

Hangzhou, Zhejiang, China

View Full Details on ClinicalTrials.gov

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NCT03917043

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