A Study of Evaluating Dual Inhibitor of PAK4 and NAMPT ATG-019 in Advanced Solid Tumors or Non-Hodgkin's Lymphoma (TEACH)
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|ClinicalTrials.gov Identifier: NCT04281420|
Recruitment Status : Not yet recruiting
First Posted : February 24, 2020
Last Update Posted : March 4, 2020
|Condition or disease||Intervention/treatment||Phase|
|Solid Tumor, Non-Hodgkin's Lymphoma||Drug: ATG-019 Combination Product: ATG-019 + Niacin ER||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||70 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||ATG-019 ATG-019+Niacin ER|
|Masking:||None (Open Label)|
|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|
Experimental: ATG-019 Alone
A starting does of 30 mg QoD×3 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.
- 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.
- 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.
- 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.
- Peak Plasma Concentration (Cmax) [ Time Frame: 18 months ]To determine the maximum plasma concentration (Cmax) for dose escalation phase.
- 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.
- To determine RP2D* [ Time Frame: 18 months ]RP2D will be determined by SMC for dose escalation phase.
- 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.
- 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.
- 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.
- Overall Survival (OS) [ Time Frame: 18 months ]The duration of time from date of first dose of study treatment until death from any cause.
- Time to progression (TTP) [ Time Frame: 18 months ]The duration of time from date of first dose of study treatment to date of PD.
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
|Contact: Shimin Sun Sun, MDfirstname.lastname@example.org|
|Contact: Qiaoqiao Chen, MA.Scemail@example.com|
|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|
|Study Director:||Aihua Wang, MD; PhD||Medical Monitor|