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Neuroendocrine TumorsPhase 1NCT04893759

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

A Phase 1 study testing Pelcitoclax in people with Neuroendocrine Tumors, run by Ascentage Pharma Group Inc. at 3 sites in China.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Neuroendocrine Tumors
What is being tested?
Pelcitoclax
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2 participants
Where
3 sitesChina
Study dates
6 Jan 2022to 14 Sep 2022
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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).
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  • 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.

Trial locations and contacts

3 sites in 1 country.

China3 sites

  • The First Affiliated Hospital of Sun Yat-Sen University

    Guangzhou, Guangdong, 510080

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 200032

Other trials in China

About this study

Official title: A Phase IB Study of Safety, Efficacy and Pharmacokinetic of Intravenously Administered Pelcitoclax (APG-1252) in Patients With Advanced Neuroendocrine Tumor

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.

Being tested
Pelcitoclax
Keywords
BCL-2, BCL-xl
Medical subject headings
Neuroendocrine Tumors

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PelcitoclaxDrug

    Also called APG-1252

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

Study groups in NCT04893759
Study groupRoleWhat they receive
APG-1252ExperimentalNot described
Receives: Drug: Pelcitoclax

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 28 days

  2. Safety data

    Incidence of adverse events (AEs)

    Measured: 24 months

Secondary outcomes (4)

  1. Preliminary Efficacy

    Objective response rate (ORR) assessed by RECIST 1.1

    Measured: 24 months

  2. Preliminary Efficacy

    Progress free survival (PFS) assessed by RECIST 1.1

    Measured: 24 months

  3. Preliminary Efficacy

    Disease control rate assessed (DCR) by RECIST 1.1

    Measured: 24 months

  4. Pharmacokinetic

    Peak plasma concentration (Cmax)

    Measured: 28 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 May 2021
  2. Study start6 Jan 2022
  3. Primary completion14 Sep 2022
  4. Study completion14 Sep 2022

Why it stopped: Company Strategy

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
2 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04893759
Sponsor's protocol ID
APG1252EC101
Status last verified
Apr 2025
First submitted
11 May 2021
Last updated
17 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Pelcitoclax in people with Neuroendocrine Tumors, run by Ascentage Pharma Group Inc. at 3 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 17 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Company Strategy). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum tolerated dose (MTD) determination (time frame: 28 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04893759.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2025.

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