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Small Cell Lung Cancer and Other Solid TumorsPhase 1NCT03387332

APG-1252 in Patients With SCLC or Advanced Solid Tumors

A Phase 1 study testing APG-1252 in people with Small Cell Lung Cancer and Other Solid Tumors, run by Ascentage Pharma Group Inc. at 1 site 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
What is being tested?
APG-1252
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteChina
Study dates
1 Dec 2017to 15 Apr 2021
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 or cytologically confirmed small cell lung cancer (SCLC) or other solid tumors;
  • Male or non-pregnant, non-lactating female patients age ≥18 years;
  • Locally advanced or metastatic disease for which no standard therapy is judged appropriate by the investigator;
  • Eastern Cooperative Oncology Group (ECOG) Performance Status ≤2;
  • Adequate hematologic function as indicated by:
  • Platelet count ≥ 100,000/mm3
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  • Hemoglobin ≥ 9.0g/dL
  • Absolute neutrophil count (ANC) ≥1000/µL
  • Adequate renal and liver function as indicated by:
  • Serum creatinine ≤ 1.5 x upper limit of normal (ULN); if serum creatinine is >1.5 X ULN, creatinine clearance must be ≥ 50 mL/min (see Section 22.3).
  • Total bilirubin ≤1.5 x ULN; If Gilbert's Syndrome may have Bilirubin> 1.5 x ULN
  • Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤3 x ULN of institution's normal range; for patients with known liver metastases, AST and ALT may be ≤ 5 x ULN.
  • Coagulation: aPTT and PT<1.2 x the upper limit of normal
  • Brain metastases with clinically controlled neurologic symptoms, defined as surgical excision and/or radiation therapy followed by 21 days of stable neurologic function \& no evidence of CNS disease progression as determined by CT or MRI within 21 days prior to the first dose of study drug.
  • 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

  • Receiving concurrent anti-cancer therapy (chemotherapy, radiation therapy, surgery, immunotherapy, hormonal therapy, targeted therapy, biologic therapy, with the exception of hormones for hypothyroidism or estrogen replacement therapy (ERT), anti estrogen analogs, agonists required to suppress serum testosterone levels); or any investigational therapy, or has had tumor embolization or tumor lysis syndrome (TLS) within 14 days prior to the first dose of study drug.
  • Steroid therapy for anti-neoplastic intent within 7 days prior to the first dose of study drug.
  • 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.
  • Received a biologic (G-CSF, GM-CSF or erythropoietin) within 28 days prior to the first dose of study drug.
  • 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.
  • Neurologic instability per clinical evaluation due to tumor involvement of the central nervous system (CNS). Patients with CNS tumors that have been treated, are asymptomatic and who have discontinued steroids (for the treatment of CNS tumors) for >28 days may be enrolled;
  • Active symptomatic fungal, bacterial and/or viral infection including, but not limited to, active human immunodeficiency virus (HIV) or viral hepatitis (B or C);
  • Diagnosis of fever and neutropenia within 1 week prior to study drug administration.
  • 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

1 site in 1 country.

China1 site

  • Guangdong General Hospital

    Guangzhou, Guangdong, 510080

Other trials in China

About this study

Official title: A Phase I Study of the Safety, Pharmacokinetic and Pharmacodynamic Properties of Intravenously Administered APG-1252 in Patients With Small Cell Lung Cancer (SCLC) or Advanced Solid Tumors.

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 SCLC or other 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.

Being tested
APG-1252
Keywords
Bcl-2/Bcl-xL dual inhibitor
Medical subject headings
Small Cell Lung Carcinoma

What participants receive

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

  • APG-1252Drug

    Also called APG-1252 for injection

    Multiple dose cohorts, 30 minute IV infusion, twice weekly for 3 weeks of a cycle with 28 days.

Study groups in NCT03387332
Study groupRoleWhat they receive
APG-1252ExperimentalThe starting dose for this study was 40 mg and 1 patient would be enrolled at this dose level. The dose escalation will convert to a standard 3+3 design following the occurrence of DLT or two ≥ Grade 2 adverse event or at doses 80 mg.
Receives: Drug: APG-1252

What is being measured

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

  1. Dose limit toxicity (DLT) determination

    Number of participants with APG-1252 treatment-related adverse events as assessed by CTCAE v4.03

    Measured: 18-24 months

  2. Maximum tolerated dose (MTD) determination

    If ≥ 2/6 patients develop a DLT at any dose level, then this dose will be declared as the MTD.

    Measured: 18-24 months

Secondary outcomes (2)

  1. Pharmacokinetic evaluation

    Peak plasma concentration (Cmax) will be assessed on all participants with APG-1252 treatments.

    Measured: 18-24 months

  2. Preliminary efficacy assessment

    Patients will be evaluated for response every 2 cycles (i.e., 8 weeks), according to the new response evaluation criteria in solid tumors: revised RECIST Guideline, Version 1.1

    Measured: 18-24 months

Timeline

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

  1. First posted2 Jan 2018
  2. Study start1 Dec 2017
  3. Primary completion9 Nov 2020
  4. Study completion15 Apr 2021

Why it stopped: The company adjusts 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
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03387332
Sponsor's protocol ID
APG-1252-CH-001
Status last verified
Aug 2021
First submitted
13 Dec 2017
Last updated
27 Aug 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing APG-1252 in people with Small Cell Lung Cancer and Other Solid Tumors, run by Ascentage Pharma Group Inc. at 1 site 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 17 inclusion and 17 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 27 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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: The company adjusts 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?

Dose limit toxicity (DLT) determination (time frame: 18-24 months). 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 NCT03387332.

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 27 Aug 2021.

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