A Study of Evaluating Dual Inhibitor of PAK4 and NAMPT ATG-019 in Advanced Solid Tumors or Non-Hodgkin's Lymphoma

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

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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Written informed consent obtained prior to any screening procedures and in accordancewith local and institutional guidelines.
  2. Age ≥18 years.
  3. 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.
  4. Patients must have objective evidence of PD on study entry:
  5. Advanced solid tumors: Measureable disease as defined by RECIST 1.11.
  6. NHL: Measureable disease including target lesion(s) as defined by the Cheson 2014Classification2 for initial evaluation and staging.
  7. Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1.
  8. Adequate hepatic function.
  9. Adequate renal function.
  10. Life expectancy of ≥ 3 months.
  11. Adequate hematopoietic function.
  12. 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:

  1. Female patients who are pregnant or lactating.
  2. Time since the last prior therapy for treatment of advanced solid tumors or NHL**:
  3. Radiation, chemotherapy, immunotherapy or any other anticancer therapy, includinginvestigational anti-cancer therapy ≤ 4 weeks prior to C1D1.
  4. Palliative steroids for disease related symptoms within 7 days prior to C1D1.
  5. Known central nervous system metastases.
  6. Major surgery within 4 weeks before C1D1.
  7. Impaired cardiac function or clinically significant cardiac diseases.
  8. Active infection with completion of therapeutic antibiotics, antivirals, orantifungals within 1 week prior to C1D1.
  9. Patients diagnosed with tuberculosis and had received treatment.
  10. Patients with a known history of human immunodeficiency virus (HIV).
  11. Known, active hepatitis A, B, or C infection.
  12. 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

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 (may be titrated to 1,000 mg of daily dose, per label), in patients with advanced solid tumors or non-Hodgkin's lymphoma (NHL) for which all standard therapeutic options considered useful by the investigator have been exhausted and with PD at study entry. The MTD and RP2D will be determined.

Connect with a study center

  • Jiangsu Province Hospital

    Nanjing, Jiangsu 210029
    China

    Site Not Available

  • Fudan University Zhongshan Hospital

    Shanghai, Shanghai 200032
    China

    Site Not Available

  • Xinhua Hospital Affiliated To Shanghai Jiaotong University School of Medicine

    Shanghai, Shanghai 200092
    China

    Site Not Available

  • Kaohsiung Chang Gung Memorial Hospital (CGMHKS)

    Kaohsiung, 83301
    Taiwan

    Site Not Available

  • Kaohsiung Medical University Chung-Ho Memorial Hospital (KMUH)

    Kaohsiung, 807
    Taiwan

    Site Not Available

  • China Medical University Hospital (CMUH)

    Taichang, 40447
    Taiwan

    Site Not Available

  • National Cheng Kung University Hospital (NCKUH)

    Tainan, 70457
    Taiwan

    Site Not Available

  • Tri-Service General Hospital (TSGH)

    Taipei, 114
    Taiwan

    Site Not Available

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