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

NCT04893759 | Terminated Phase 1

• 1 other identifier: APG1252EC101
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 3

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.

Conditions

Neuroendocrine Tumors

Keywords

BCL-2; BCL-xl

Outcome Measures

Primary Outcomes (2)

• Maximum tolerated dose (MTD) determination

  If ≥ 2/6 patients develop a DLT at any dose level, then the MTD will be assumed to have been exceeded. The dose level immediately below will then be expanded to 6 patients and, if no more than 1/6 patients develop DLT, then this dose will be declared the MTD.

  28 days

• Safety data

  Incidence of adverse events (AEs)

  24 months

Secondary Outcomes (4)

• Preliminary Efficacy

  24 months

• Preliminary Efficacy

  24 months

• Preliminary Efficacy

  24 months

• Pharmacokinetic

  28 days

Study Arms (1)

APG-1252

EXPERIMENTAL

Drug: Pelcitoclax

Interventions

Pelcitoclax DRUG

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

Also known as: APG-1252

APG-1252

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed neuroendocrine tumors (G1, G2, G3).
• Locally advanced or metastatic disease for which no standard therapy is judged appropriate by the investigator.
• Male or non-pregnant, non-lactating female patients age ≥18 years.
• Eastern Cooperative Oncology Group (ECOG) Performance Status ≤1.
• Estimated life span ≥3 months.
• At least one measurable lesion by RECIST 1.1.
• Adequate hematologic and bone marrow functions.
• Adequate renal and liver function.
• Adequate cardiac function.
• Brain metastases with clinically controlled neurologic symptoms.
• 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.
• 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).
• Willingness and ability to comply with study procedures and follow-up examination.

You may not qualify if:

• Neuroendocrine carcinoma (NEC).
• 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.
• Continuance of toxicities due to prior radiotherapy or chemotherapy agents that do not recover to \< Grade 2.
• Known bleeding diathesis/disorder.
• Recent history of non-chemotherapy induced thrombocytopenia associated bleeding within 1 year prior to first dose of study drug.
• 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).
• Serious gastrointestinal bleeding within 3 months.
• 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.
• 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.
• Unstable angina, myocardial infarction, or a coronary revascularization procedure within 180 days of study entry.
• 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.
• Prior treatment with Bcl-2/Bcl-xL inhibitors.
• Any other condition or circumstance of that would, in the opinion of the investigator, make the patient unsuitable for participation in the study.

Sponsors & Collaborators

• Ascentage Pharma Group Inc.: lead

Study Sites (3)

The First Affiliated Hospital of Sun Yat-Sen University

Guangzhou, Guangdong, 510080, China

Location

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Location

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

Location

MeSH Terms

Conditions

Neuroendocrine Tumors

Interventions

pelcitoclax

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue

Study Officials

• Minhu Chen, M.D., PhD.

  First Affiliated Hospital, Sun Yat-Sen University

  PRINCIPAL INVESTIGATOR

• Jie Chen, M.D., PhD.

  Fudan University

  PRINCIPAL INVESTIGATOR

• Xianjun Yu

  Fudan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2021
• First Posted: May 19, 2021
• Study Start: January 6, 2022
• Primary Completion: September 14, 2022
• Study Completion: September 14, 2022
• Last Updated: April 17, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)