Clinical trial · Interventional
A Trial of ATG-101 in Patients With Metastatic/Advanced Solid Tumors and Mature B-cell Non-Hodgkin Lymphomas
A Phase I Trial of ATG-101 in Patients With Metastatic/Advanced Solid Tumors and Mature B-cell Non-Hodgkin Lymphomas
NCT05490043CI-TRIAL-00094326terminatedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The sponsor has decided to adjust the development strategy of the investigational drug in this study.
Summary
Brief summary (as posted)
This is a First-in-Human Phase I trial of ATG-101 in Patients with Metastatic/Advanced Solid Tumors and Mature B-cell Non-Hodgkin Lymphomas.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
| Mature B-cell Non-Hodgkin Lymphoma | Mature B-Cell Non-Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.98 |
| Metastatic Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ATG-101 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- ATG-101
- description
- Dose Escalation Phase: Will be conducted with an enhanced PDx cohort. Dose Expansion Phase: Subjects with advanced or metastatic solid tumors and mature B-NHLs will be enrolled.
- interventionNames
- Drug: ATG-101
Primary outcomes (2)
- measure
- AEs/SAEs
- timeFrame
- One year after last patient first dose
- description
- Toxicity will be graded according to the NCI CTCAE, Version 5.0.
- measure
- DLT (for Dose Escalation Phase only)
- timeFrame
- One year after last patient first dose
- description
- The DLTs will be evaluated during Cycle 1 of treatment. Toxicity will be graded according to the National Cancer Institute-Common Terminology Criteria for Adverse Events. The DLTs for this study may include the following: Cytokine release syndrome, Hematologic toxicity, Non-hematologic toxicity.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Provision of signed and dated, written informed consent prior to any study-specific procedures, sampling, and analyses. 2. Aged 18 to 75 years as of the date of consent. 3. Histological or cytological confirmation of a solid tumor, and has relapsed or refractory from standard therapies. 4. Subjects with solid tumors have at least 1 measurable lesion per RECIST v1.1. 5. Estimated life expectancy of a minimum of 12 weeks. 6. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 at ICF signature. Exclusion Criteria: 1. Subjects with CNS tumors or known CNS metastases will be excluded from the Dose Escalation Phase. 2. Prior treatment with a 4-1BB agonist. 3. Subjects with primary liver cancer. 4. Known history of human immunodeficiency virus infection. 5. History of hypersensitivity or history of allergic reactions attributed to drugs with a similar chemical or biologic structure or class to ATG-101. 6. Pregnant or nursing females.
References
Publications (0)
Data not yet available
No reference posted for this study.