Clinical trial · Interventional
A Study of Evaluating Dual Inhibitor of PAK4 and NAMPT ATG-019 in Advanced Solid Tumors or Non-Hodgkin's Lymphoma
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Because the sponsor modified the study-product development strategy.
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Solid Tumor, Non-Hodgkin's Lymphoma | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ATG-019 | Drug | — | UNRESOLVED |
| ATG-019 + Niacin ER | Combination Product | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- ATG-019 Alone
- description
- A starting does of 30 mg QoD×3 ATG-019
- interventionNames
- Drug: ATG-019
- type
- EXPERIMENTAL
- label
- ATG-019 + Niacin ER
- description
- A starting dose of 60 mg ATG-019 and 500 mg niacin ER
- interventionNames
- Combination Product: ATG-019 + Niacin ER
Primary outcomes (3)
- measure
- To determine MTD* or RP2D*
- timeFrame
- 18 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available