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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04281420
Recruitment Status : Not yet recruiting
First Posted : February 24, 2020
Last Update Posted : March 4, 2020
Sponsor:
Information provided by (Responsible Party):
Antengene Corporation ( Antengene Therapeutics Limited )

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 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).

Condition or disease Intervention/treatment Phase
Solid Tumor, Non-Hodgkin's Lymphoma Drug: ATG-019 Combination Product: ATG-019 + Niacin ER Phase 1

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 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: ATG-019 ATG-019+Niacin ER
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Estimated Study Start Date : March 2020
Estimated Primary Completion Date : August 2023
Estimated Study Completion Date : November 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: ATG-019 Alone
A starting does of 30 mg QoD×3 ATG-019
Drug: ATG-019
ATG-019 30 mg QoD×3 is selected as the staring dose. Oral ATG-019 will be taken three times a week every other day (Days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26) during each 28-day cycle.
Other Name: KPT-9274

Experimental: ATG-019 + Niacin ER
A starting dose of 60 mg ATG-019 and 500 mg niacin ER
Combination Product: ATG-019 + Niacin ER
ATG-019 60 mg is selected as starting dose. Oral ATG-019 will be taken three times a week every other day (Days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26) during each 28-day cycle. And a starting dose of 500 mg niacin ER (may be titrated up to 1,000 mg of daily dose, per label) co-administered with each dose of ATG-019.




Primary Outcome Measures :
  1. To determine MTD* or RP2D* [ Time Frame: 18 months ]
    MTD will be evaluated using the NCI-CTCAE, Version 5.0; RP2D will be determined by SMC for dose escalation phase.

  2. To evaluate the Dose-Limiting Toxicity (DLT) for dose escalation phase [ Time Frame: 18 months ]
    DLTs will be evaluated using the CTCAE, Version 5.0 for grading.

  3. Overall Response Rate (ORR) [ Time Frame: 18 months ]
    ORR analysis will be performed for both study phases by calculating the point estimate of the percentage of patients who have either CR or PR, presented as the number and percentage of patients, including a two-sided 95% CI.


Secondary Outcome Measures :
  1. Peak Plasma Concentration (Cmax) [ Time Frame: 18 months ]
    To determine the maximum plasma concentration (Cmax) for dose escalation phase.

  2. Time to Reach Cmax (Tmax) [ Time Frame: 18 months ]
    To evaluate the time to reach Cmax after single and multiple doses for dose escalation phase.

  3. To determine RP2D* [ Time Frame: 18 months ]
    RP2D will be determined by SMC for dose escalation phase.

  4. Duration of response (DOR) [ Time Frame: 18 months ]
    The duration of time from first meeting CR or PR measurement criteria (whichever occurs first) until the first date that PD recurrence is objectively documented.

  5. Disease control rate (DCR) [ Time Frame: 18 months ]
    The analysis of DCR will be similar to that described for ORR, for patients who achieve CR, PR, or SD for ≥ 8 weeks.

  6. Progression-free survival (PFS) [ Time Frame: 18 months ]
    The duration of time from date of first dose of study treatment until the first date that PD is objectively documented or death due to any cause.

  7. Overall Survival (OS) [ Time Frame: 18 months ]
    The duration of time from date of first dose of study treatment until death from any cause.

  8. Time to progression (TTP) [ Time Frame: 18 months ]
    The duration of time from date of first dose of study treatment to date of PD.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion 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:

    1. Advanced solid tumors: Measureable disease as defined by RECIST 1.11.
    2. 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**:

    1. Radiation, chemotherapy, immunotherapy or any other anticancer therapy, including investigational anti-cancer therapy ≤ 4 weeks prior to C1D1.
    2. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04281420


Contacts
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Contact: Shimin Sun Sun, MD 13701803117 jasmine.sun@antengene.com
Contact: Qiaoqiao Chen, MA.Sc 13675893326 stacey.chen@antengene.com

Locations
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Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital (KMUH)
Kaohsiung, Taiwan, 807
Contact: Hui-Hua Hsiao         
Kaohsiung Chang Gung Memorial Hospital (CGMHKS)
Kaohsiung, Taiwan, 83301
Contact: Yen-Yang Chen         
China Medical University Hospital (CMUH)
Taichang, Taiwan, 40447
Contact: Li-Yuan Bai         
National Cheng Kung University Hospital (NCKUH)
Tainan, Taiwan, 70457
Contact: Chia-Jui Yen         
Tri-Service General Hospital (TSGH)
Taipei, Taiwan, 114
Contact: Ching-Liang Ho         
Sponsors and Collaborators
Antengene Therapeutics Limited
Investigators
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Study Director: Aihua Wang, MD; PhD Medical Monitor

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Responsible Party: Antengene Therapeutics Limited
ClinicalTrials.gov Identifier: NCT04281420    
Other Study ID Numbers: ATG-019-STL-001
First Posted: February 24, 2020    Key Record Dates
Last Update Posted: March 4, 2020
Last Verified: February 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Niacin
Niacinamide
Nicotinic Acids
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Vasodilator Agents
Vitamin B Complex
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs