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Clinical Trials List

Protocol NumberATG-019-STL-001
NCT Number(ClinicalTrials.gov Identfier)NCT04281420

2019-12-01 - 2022-12-31

Phase I

Not yet recruiting2

Recruiting3

A Phase I Open-Label Study of the Safety and Tolerability of ATG-019, a Dual Inhibitor of PAK4 and NAMPT, in patients with Advanced Solid Tumors or Non-Hodgkin's Lymphoma.

  • Trial Applicant

    Clinipace Taiwan Co., Ltd

  • Sponsor

    Antengene Therapeutics Limited

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2025/08/20

Investigators and Locations

Principal Investigator Li-Yuan Bai Division of Hematology & Oncology
China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 何景良 Division of Hematology & Oncology
Tri-Service General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 陳彥仰 Division of Hematology & Oncology
Kaoshiung Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator Hui-Hua Hsiao Division of Hematology & Oncology
Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator Chia-Jui Yen Division of General Internal Medicine
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Solid Tumor/Non-Hodgkin's Lymphoma

Objectives

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 NAMPT, alone or co-administered with starting dose of 500 mg niacin ER in patients with advanced solid tumors or non-Hodgkin's lymphoma (NHL).

Test Drug

ATG-019

Active Ingredient

ATG-019

Dosage Form

Tablet

Dosage

5mg
20mg

Endpoints

Primary Outcome Measures:
1.To determine MTD or RP2D
2.To evaluate the Dose-Limiting Toxicity (DLT) for dose escalation phase
3.Overall Response Rate (ORR)

Secondary Outcome Measures:
1.Peak Plasma Concentration (Cmax)
2.Time to Reach Cmax （Tmax）
3.To determine RP2D
4.Duration of response (DOR)
5.Disease control rate (DCR)
6.Progression-free survival (PFS)
7.Overall Survival (OS)
8.Time to progression (TTP)

Inclution Criteria

1.Written informed consent obtained prior to any screening procedures and in accordance with local and institutional guidelines.
2.Age ≥18 years.
3.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.
4.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.
5.Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1.
6.Adequate hepatic function.
7.Adequate renal function.
8.Life expectancy of ≥ 3 months.
9.Adequate hematopoietic function.
10.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 Criteria

1.Female patients who are pregnant or lactating.
2.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.
3.Known central nervous system metastases.
4.Major surgery within 4 weeks before C1D1.
5.Impaired cardiac function or clinically significant cardiac diseases.
6.Active infection with completion of therapeutic antibiotics, antivirals, or antifungals within 1 week prior to C1D1.
7.Patients diagnosed with tuberculosis and had received treatment.
8.Patients with a known history of human immunodeficiency virus (HIV).
9.Known, active hepatitis A, B, or C infection.
10.Serious psychiatric or medical conditions that, in the opinion of the Investigator, could interfere with treatment, compliance, or the ability to give consent.

The Estimated Number of Participants

  • Taiwan

    39 participants

  • Global

    70 participants

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