A Study of Pelcitoclax (APG-1252) in Patients With Neuroendocrine Tumors

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Histologically confirmed neuroendocrine tumors (G1, G2, G3). 2. Locally advanced or metastatic disease for which no standard therapy is judged appropriate by the investigator. 3. Male or non-pregnant, non-lactating female patients age ≥18 years. 4. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤1. 5. Estimated life span ≥3 months. 6. At least one measurable lesion by RECIST 1.1. 7. Adequate hematologic and bone marrow functions. 8. Adequate renal and liver function. 9. Adequate cardiac function. 10. Brain metastases with clinically controlled neurologic symptoms. 11. Willingness to use contraception by a method that is deemed effective by the investigator by both males and female patients of child bearing potential (postmenopausal women must have been amenorrheal for at least 12 months to be considered of non-childbearing potential) and their partners throughout the treatment period and for at least three months following the last dose of study drug. 12. Ability to understand and willingness to sign a written informed consent form (the consent form must be signed by the patient prior to any study-specific procedures). 13. Willingness and ability to comply with study procedures and follow-up examination.

Exclusion Criteria:

1. Neuroendocrine carcinoma (NEC). 2. Received chemotherapy, radiation therapy, surgery, immunotherapy, hormonal therapy, targeted therapy, biologic therapy, or any investigational therapy within 28 days prior to the first dose of study drug; received TKIs within 5 x half-time. 3. Continuance of toxicities due to prior radiotherapy or chemotherapy agents that do not recover to < Grade 2. 4. Known bleeding diathesis/disorder. 5. Recent history of non-chemotherapy induced thrombocytopenia associated bleeding within 1 year prior to first dose of study drug. 6. Have active immune thrombocytopenic purpura (ITP), active autoimmune hemolytic anemia (AIHA), or a history of being refractory to platelet transfusions (within 1 year prior to the first dose of study drug). 7. Serious gastrointestinal bleeding within 3 months. 8. Use of therapeutic doses of anti-coagulants is excluded, along with anti-platelet agents; low-dose anticoagulation medications that are used to maintain the patency of a central intravenous catheter are permitted. 9. Failure to recover adequately, as judged by the investigator, from prior surgical procedures. Patients who have had major surgery within 28 days from study entry, and patients who have had minor surgery within 14 days of study entry. 10. Unstable angina, myocardial infarction, or a coronary revascularization procedure within 180 days of study entry. 11. Uncontrolled concurrent illness including, but not limited to: serious uncontrolled infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with the study requirements. 12. Prior treatment with Bcl-2/Bcl-xL inhibitors. 13. Any other condition or circumstance of that would, in the opinion of the investigator, make the patient unsuitable for participation in the study.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04893759
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Ascentage Pharma Group Inc.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Minhu Chen, M.D., PhD.Jie Chen, M.D., PhD.Xianjun Yu
Principal Investigator Affiliation First Affiliated Hospital, Sun Yat-Sen UniversityFudan UniversityFudan University
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries China
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Neuroendocrine Tumors
Arms & Interventions

Arms

Experimental: APG-1252

Interventions

Drug: - Pelcitoclax

Multiple dose cohorts, 30 minute IV infusion, once a week, 28 days as a cycle

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Guangzhou, Guangdong, China

Status

Recruiting

Address

The First Affiliated Hospital of Sun Yat-Sen University

Guangzhou, Guangdong, 510080

Site Contact

Ning Zhang, Master

[email protected]

+86-20-28068501

Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China

Status

Not yet recruiting

Address

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong,

Site Contact

Wei Wang, M.D.

[email protected]

+86-20-28068501

Fudan University Shanghai Cancer Center, Shanghai, Shanghai, China

Status

Not yet recruiting

Address

Fudan University Shanghai Cancer Center

Shanghai, Shanghai, 200032

Site Contact

Jie Chen, M.D., PhD.

[email protected]

+86-20-28068501

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