Status:
TERMINATED
A Study of Evaluating Dual Inhibitor of PAK4 and NAMPT ATG-019 in Advanced Solid Tumors or Non-Hodgkin's Lymphoma
Lead Sponsor:
Antengene Therapeutics Limited
Conditions:
Solid Tumor, Non-Hodgkin's Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This is a multi-center, open-label clinical study with separate Dose Escalation and Expansion Phases to assess preliminary safety, tolerability, and efficacy of ATG-019, a dual inhibitor of PAK4 and N...
Detailed Description
This is a multi-center, open-label clinical study with separate Dose Escalation and Expansion Phases to assess preliminary safety, tolerability, and efficacy of ATG-019, a dual inhibitor of PAK4 and N...
Eligibility Criteria
Inclusion
- Written informed consent obtained prior to any screening procedures and in accordance with local and institutional guidelines.
- Age ≥18 years.
- Patients with histologically or cytologically confirmed, NHL or advanced solid tumors which 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 2014 Classification2 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 of contraception (including one highly effective and one effective method of contraception) and have a negative serum pregnancy test at Screening, and male patients must use an effective barrier method of contraception if sexually active with a female of child-bearing potential.
Exclusion
- 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, including investigational 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, or antifungals 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.
Key Trial Info
Start Date :
April 13 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 2 2023
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04281420
Start Date
April 13 2020
End Date
October 2 2023
Last Update
April 30 2024
Active Locations (8)
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1
Jiangsu Province Hospital
Nanjing, Jiangsu, China, 210029
2
Fudan University Zhongshan Hospital
Shanghai, Shanghai Municipality, China, 200032
3
Xinhua Hospital Affiliated To Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China, 200092
4
Kaohsiung Medical University Chung-Ho Memorial Hospital (KMUH)
Kaohsiung City, Taiwan, 807