AzTrials
AzTrials

Solid Tumor, Non-Hodgkin's LymphomaPhase 1TEACHNCT04281420

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

A Phase 1 study testing ATG-019 and ATG-019 + Niacin ER in people with Solid Tumor, Non-Hodgkin's Lymphoma, run by Antengene Therapeutics Limited at 8 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Solid Tumor, Non-Hodgkin's Lymphoma
What is being tested?
ATG-019 and ATG-019 + Niacin ER
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
8 sitesin 2 countries
Study dates
13 Apr 2020to 2 Oct 2023
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 12Show fewer
  • 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.

Who cannot join

  • 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.
Show all 12Show fewer
  • 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.

Trial locations and contacts

8 sites in 2 countries.

8 sites in 2 countries

Taiwan5 sites

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

    Kaohsiung City, 807

  • Kaohsiung Chang Gung Memorial Hospital (CGMHKS)

    Kaohsiung City, 83301

  • China Medical University Hospital (CMUH)

    Taichang, 40447

  • National Cheng Kung University Hospital (NCKUH)

    Tainan, 70457

  • Tri-Service General Hospital (TSGH)

    Taipei, 114

Other trials in Taiwan

China3 sites

  • Jiangsu Province Hospital

    Nanjing, Jiangsu, 210029

  • Fudan University Zhongshan Hospital

    Shanghai, Shanghai Municipality, 200032

  • Xinhua Hospital Affiliated To Shanghai Jiaotong University School of Medicine

    Shanghai, Shanghai Municipality, 200092

Other trials in China

About this study

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

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).

Read the 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.

Being tested
ATG-019, ATG-019 + Niacin ER
Medical subject headings
Lymphoma, Non-Hodgkin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ATG-019Drug

    Also called KPT-9274

    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.

  • ATG-019 + Niacin ERCombination product

    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.

Study groups in NCT04281420
Study groupRoleWhat they receive
ATG-019 AloneExperimentalA starting does of 30 mg QoD×3 ATG-019
Receives: Drug: ATG-019
ATG-019 + Niacin ERExperimentalA starting dose of 60 mg ATG-019 and 500 mg niacin ER
Receives: Combination Product: ATG-019 + Niacin ER

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To determine MTD* or RP2D*

    MTD will be evaluated using the NCI-CTCAE, Version 5.0; RP2D will be determined by SMC for dose escalation phase.

    Measured: 18 months

  2. To evaluate the Dose-Limiting Toxicity (DLT) for dose escalation phase

    DLTs will be evaluated using the CTCAE, Version 5.0 for grading.

    Measured: 18 months

  3. Overall Response Rate (ORR)

    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.

    Measured: 18 months

Secondary outcomes (8)

  1. Peak Plasma Concentration (Cmax)

    To determine the maximum plasma concentration (Cmax) for dose escalation phase.

    Measured: 18 months

  2. Time to Reach Cmax （Tmax）

    To evaluate the time to reach Cmax after single and multiple doses for dose escalation phase.

    Measured: 18 months

  3. To determine RP2D*

    RP2D will be determined by SMC for dose escalation phase.

    Measured: 18 months

  4. Duration of response (DOR)

    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.

    Measured: 18 months

  5. Disease control rate (DCR)

    The analysis of DCR will be similar to that described for ORR, for patients who achieve CR, PR, or SD for ≥ 8 weeks.

    Measured: 18 months

  6. Progression-free survival (PFS)

    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.

    Measured: 18 months

  7. Overall Survival (OS)

    The duration of time from date of first dose of study treatment until death from any cause.

    Measured: 18 months

  8. Time to progression (TTP)

    The duration of time from date of first dose of study treatment to date of PD.

    Measured: 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Feb 2020
  2. Study start13 Apr 2020
  3. Primary completion2 Oct 2023
  4. Study completion2 Oct 2023

Why it stopped: Because the sponsor modified the study-product development strategy.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
ATG-019 ATG-019+Niacin ER
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04281420
Sponsor's protocol ID
ATG-019-STL-001
Acronym
TEACH
Status last verified
Jul 2022
First submitted
18 Feb 2020
Last updated
30 Apr 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ATG-019 and ATG-019 + Niacin ER in people with Solid Tumor, Non-Hodgkin's Lymphoma, run by Antengene Therapeutics Limited at 8 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 30 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in Taiwan, China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Because the sponsor modified the study-product development strategy.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To determine MTD* or RP2D* (time frame: 18 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04281420.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in