APG-1252 Monotherapy or in Combination With Other Therapeutic Agent in Subjects With Relapsed or Refractory Non-Hodgkin Lymphoma

NCT05186012 | Recruiting Phase 1

• 1 other identifier: APG1252LC101
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 4

Brief Summary

The purpose of this study is to assess the safety, pharmacokinetic, pharmacodynamic and efficacy of APG-1252 single agent and in combination with other therapeutic agent in patients with NHL.

Conditions

NHL, Adult

Keywords

APG-1252

Outcome Measures

Primary Outcomes (2)

• Dose Limiting Toxicity (DLT)

  DLT will be defined based on the rate of drug-related grade 3-5 adverse events experienced within the first 28 days of study treatment. These will be assessed via CTCAE version 5.0.

  28 days

• Maximally tolerated dose (MTD)

  MTD will be determined based on DLTs observed during the first 28 days of study treatment.

  28 days

Study Arms (2)

Arm A (Single agent)

EXPERIMENTAL

Drug: APG-1252

Arm B (combo)

EXPERIMENTAL

Drug: APG-1252; Drug: Chidamide

Interventions

APG-1252 DRUG

APG-1252 administered via intravenous infusion for 30 minutes weekly (Day 1, 8, 15, 22).Every 28 days as a cycle.

Also known as: Pelcitoclax

Arm A (Single agent); Arm B (combo)

Chidamide DRUG

Chidamide 30mg orally BIW. Every 28 days as a cycle.

Arm B (combo)

Eligibility Criteria

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

You may qualify if:

• Life expectancy ≥ 3 months.
• Eastern Cooperative Oncology Group (ECOG) 0-1.
• Corrected QT interval (QTcB or QTcF ) ≤ 450ms (male), or ≤ 470ms (female).
• Patients with relapsed/refractory NHL in Part 1 (excluding Burkitt's lymphoma, lymphoblastic lymphoma, chronic lymphocytic leukemia/small lymphocytic lymphoma or primary central nervous system lymphoma) and relapsed/refractory PTCL in Part 2, previously treated with at least 1 prior line of therapy.
• Patients must have an adequate bone marrow function.
• Adequate hepatic, renal and coagulation function.
• Male and female subjects of childbearing potential who agree to use highly effective methods of birth control during the period of therapy and for 90 days after the last dose of study drug.
• Ability to understand and voluntarily sign a written informed consent form before performing any study procedures.
• Compliance to study procedures.

You may not qualify if:

• Prior history of allogeneic cell transplant, adoptive cellular immunotherapy within 2 years, or autologous hematopoietic stem cell transplantation within 6 months prior to the first dose.
• Monoclonal antibody therapy within 4 weeks prior to the first dose.
• Received anti-cancer therapy within 14 days prior to the first dose of therapy, including chemotherapy, radiotherapy, immunotherapy or hormone therapy for anti-tumor purposes; or 28 days for any investigational agent prior to the first dose of therapy.
• Continuance of toxicities due to prior radiotherapy or chemotherapy agents that do not recover to ≤ Grade 1 except alopecia or neuropathy.
• Not recovered from recent surgical procedures based on investigator's discretion. Major surgical procedure within ≤28 days or minor surgical procedure (excluding biopsy) within ≤14 days prior to initiating study treatment.
• Prior exposure to BCL-xL inhibitor. Subjects who have been treated with chidamide can still be included in the study unless they were intolerant.
• Intolerant to other Bcl-2 family protein inhibitors.
• Has known central nervous system (CNS) involvement or the prior history of primary central nervous system lymphoma.
• Prior history of cardiovascular disease ≥ grade 2 (New York Heart Association grade 2 cardiovascular disease is defined as that the patient feels comfortable at rest, but ordinary physical activities lead to fatigue, palpitation, dyspnea or angina pectoris). Unstable angina, myocardial infarction, or coronary revascularization within 180 days prior to the first dose.
• Known bleeding diathesis/disorder. Recent history of non-chemotherapy induced thrombocytopenia associated a major bleeding episode or a history of being refractory to platelet transfusions within 1 year prior to the first dose. Gastrointestinal bleeding or active peptic ulceration within 3 months prior to the first dose. Active immune thrombocytopenic purpura (ITP), active autoimmune hemolytic anemia (AIHA).
• A potentially bleeding condition or the presence of clinically significant bleeding signs.
• Known to be allergic to the drug component or its analogues.
• Pregnancy or lactation, or pregnancy is expected during the study period or within 3 months after the last administration of treatment.
• Within 3 years before entering the study, the subject had a history of active malignant tumors other than NHL, except that: Fully treated cervical carcinoma in situ; Completely resected basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin; Confinement and resection of previously cured malignancies (or other treatment).
• Uncontrolled systemic infections (viruses, bacteria, or fungi), including but not limited to Covid-19 RNA positive, HBV-SURFACE antigen positive and HBV-DNA≥2,000 copies/mL or ≥500 IU/ mL; Hepatitis C virus (HCV) antibody positive; human immunodeficiency virus (HIV) antibody positive.

Sponsors & Collaborators

• Ascentage Pharma Group Inc.: lead

Study Sites (4)

Henan Provincial Oncology Hospital

Zhengzhou, Henanan, China

NOT YET RECRUITING

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

NOT YET RECRUITING

Jiangsu Province Hospital

Nanyang, China

NOT YET RECRUITING

Shanghai Jiao Tong University school of medicine Ruijin Hospital

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin

Interventions

pelcitoclax; N-(2-amino-5-fluorobenzyl)-4-(N-(pyridine-3-acrylyl)aminomethyl)benzamide

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Yifan Zhai, MD, PhD

  Ascentage Pharma Group Inc.

  STUDY CHAIR

Central Study Contacts

Weili Zhao, MD.

CONTACT

13512112076; zwl_trial@163.com

Rong Tao, MD.

CONTACT

13651603660; hkutao@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2021
• First Posted: January 11, 2022
• Study Start: June 14, 2022
• Primary Completion: September 1, 2025
• Study Completion: March 1, 2026
• Last Updated: January 23, 2024

Record last verified: 2023-08

Locations

CN (4)