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Brief Title: A Study of Pelcitoclax (APG-1252) in Patients With Neuroendocrine Tumors
Official Title: A Phase IB Study of Safety, Efficacy and Pharmacokinetic of Intravenously Administered Pelcitoclax (APG-1252) in Patients With Advanced Neuroendocrine Tumor
Study ID: NCT04893759
Brief Summary: APG-1252 is a highly potent Bcl-2 family protein inhibitor, a promising drug candidate which shown high binding affinities to Bcl-2, Bcl-xL and Bcl-w. The preclinical studies have shown that APG-1252 alone achieves complete and persistent tumor regression in multiple tumor xenograft models with a twice weekly or weekly dose-schedule, including SCLC, colon, breast and ALL cancer xenografts; achieves strong synergy with the chemotherapeutic agents, indicating that APG-1252 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-1252 is intended for the treatment of patients with neuroendocrine tumors. The purpose of the phase 1b study to establish the maximum tolerated dose (MTD), and/or recommended phase 2 dose (RP2D). Preliminary efficacy and pharmacokinetic properties will be aslo evaluated.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
The First Affiliated Hospital of Sun Yat-Sen University, Guangzhou, Guangdong, China
Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China
Fudan University Shanghai Cancer Center, Shanghai, Shanghai, China
Name: Minhu Chen, M.D., PhD.
Affiliation: First Affiliated Hospital, Sun Yat-Sen University
Role: PRINCIPAL_INVESTIGATOR
Name: Jie Chen, M.D., PhD.
Affiliation: Fudan University
Role: PRINCIPAL_INVESTIGATOR
Name: Xianjun Yu
Affiliation: Fudan University
Role: PRINCIPAL_INVESTIGATOR