Last updated: April 27, 2024
Sponsor: Antengene Therapeutics Limited
Overall Status: Terminated
Phase
1
Condition
Lymphoma
Treatment
ATG-019 + Niacin ER
ATG-019
Clinical Study ID
NCT04281420
ATG-019-STL-001
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Written informed consent obtained prior to any screening procedures and in accordancewith local and institutional guidelines.
- Age ≥18 years.
- Patients with histologically or cytologically confirmed, NHL or advanced solid tumorswhich have progressed despite standard therapy, for whom no standard therapy exists,or who have refused standard therapy.
- Patients must have objective evidence of PD on study entry:
- Advanced solid tumors: Measureable disease as defined by RECIST 1.11.
- NHL: Measureable disease including target lesion(s) as defined by the Cheson 2014Classification2 for initial evaluation and staging.
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1.
- Adequate hepatic function.
- Adequate renal function.
- Life expectancy of ≥ 3 months.
- Adequate hematopoietic function.
- Female patients of child-bearing potential must agree to use dual methods ofcontraception (including one highly effective and one effective method ofcontraception) and have a negative serum pregnancy test at Screening, and malepatients must use an effective barrier method of contraception if sexually active witha female of child-bearing potential.
Exclusion
Exclusion Criteria:
- Female patients who are pregnant or lactating.
- Time since the last prior therapy for treatment of advanced solid tumors or NHL**:
- Radiation, chemotherapy, immunotherapy or any other anticancer therapy, includinginvestigational anti-cancer therapy ≤ 4 weeks prior to C1D1.
- Palliative steroids for disease related symptoms within 7 days prior to C1D1.
- Known central nervous system metastases.
- Major surgery within 4 weeks before C1D1.
- Impaired cardiac function or clinically significant cardiac diseases.
- Active infection with completion of therapeutic antibiotics, antivirals, orantifungals within 1 week prior to C1D1.
- Patients diagnosed with tuberculosis and had received treatment.
- Patients with a known history of human immunodeficiency virus (HIV).
- Known, active hepatitis A, B, or C infection.
- Serious psychiatric or medical conditions that, in the opinion of the Investigator,could interfere with treatment, compliance, or the ability to give consent.
Study Design
Total Participants: 20
Treatment Group(s): 2
Primary Treatment: ATG-019 + Niacin ER
Phase: 1
Study Start date:
April 13, 2020
Estimated Completion Date:
October 02, 2023
Study Description
Connect with a study center
Jiangsu Province Hospital
Nanjing, Jiangsu 210029
ChinaSite Not Available
Fudan University Zhongshan Hospital
Shanghai, Shanghai 200032
ChinaSite Not Available
Xinhua Hospital Affiliated To Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai 200092
ChinaSite Not Available
Kaohsiung Chang Gung Memorial Hospital (CGMHKS)
Kaohsiung, 83301
TaiwanSite Not Available
Kaohsiung Medical University Chung-Ho Memorial Hospital (KMUH)
Kaohsiung, 807
TaiwanSite Not Available
China Medical University Hospital (CMUH)
Taichang, 40447
TaiwanSite Not Available
National Cheng Kung University Hospital (NCKUH)
Tainan, 70457
TaiwanSite Not Available
Tri-Service General Hospital (TSGH)
Taipei, 114
TaiwanSite Not Available
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