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

  • STATUS
    Recruiting
  • participants needed
    70
  • sponsor
    Antengene Therapeutics Limited
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Updated on 19 February 2024
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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).

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.

Details
Condition Solid Tumor, Non-Hodgkin's Lymphoma
Age 18-100 years
Treatment ATG-019, ATG-019 + Niacin ER
Clinical Study IdentifierNCT04281420
SponsorAntengene Therapeutics Limited
Last Modified on19 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

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 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, 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
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