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

NCT ID: NCT04281420

Last Updated: 2024-04-30

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-04-13
• Study Completion Date: 2023-10-02

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).

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.

Conditions

Solid Tumor, Non-Hodgkin's Lymphoma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ATG-019 Alone

A starting does of 30 mg QoD×3 ATG-019

Group Type: EXPERIMENTAL

ATG-019

Intervention Type: DRUG

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 ER

A starting dose of 60 mg ATG-019 and 500 mg niacin ER

Group Type: EXPERIMENTAL

ATG-019 + Niacin ER

Intervention Type: COMBINATION_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.

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: COMBINATION_PRODUCT

Other Intervention Names

KPT-9274

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Antengene Therapeutics Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stephen Xie, MD; PhD

Role: STUDY_DIRECTOR

Medical Monitor

Locations

Jiangsu Province Hospital

Nanjing, Jiangsu, China

Fudan University Zhongshan Hospital

Shanghai, Shanghai Municipality, China

Xinhua Hospital Affiliated To Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, China

Kaohsiung Medical University Chung-Ho Memorial Hospital (KMUH)

Kaohsiung City, , Taiwan

Kaohsiung Chang Gung Memorial Hospital (CGMHKS)

Kaohsiung City, , Taiwan

China Medical University Hospital (CMUH)

Taichang, , Taiwan

National Cheng Kung University Hospital (NCKUH)

Tainan City, , Taiwan

Tri-Service General Hospital (TSGH)

Taipei, , Taiwan

Countries

China; Taiwan

Other Identifiers

ATG-019-STL-001

Identifier Type: -

Identifier Source: org_study_id