Clinical trial · Interventional
A Study ATG-101 in Patients With Metastatic/Advanced Solid Tumors and Mature B-cell Non-Hodgkin Lymphomas
A First-in-Human Phase I Trial of ATG-101 in Patients With Metastatic/Advanced Solid Tumors and Mature B-cell Non-Hodgkin Lymphomas
NCT04986865CI-TRIAL-00090777PROBEterminatedPhase 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): It is due to the recent changes in the competitor landscape and strategic consideration
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
- Single experimental arm for ATG-101
- description
- Subjects with advanced or metastatic solid tumors and mature B-NHLs will be enrolled.
- interventionNames
- Drug: ATG-101
Primary outcomes (3)
- measure
- AEs
- timeFrame
- One year after last patient first dose
- description
- To evaluate the safety of ATG-101. It is the responsibility of the investigator to record and document all AEs (occurring from the first dose of study treatment on C1D1) throughout the study. Clinically significant symptoms and signs related to disease progression will be reported as AEs and meet one or more of the following criteria: 1. With clinical symptoms. 2. Leading to the change of study treatment (eg, dose adjustment, dose interruption, or study drug withdraw). 3. Leading to the change of concomitant treatment (eg, adding, interrupting, or terminating concomitant medications, therapies, or treatments, or any other changes).
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 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 at least 18 years as of the date of consent. 3. Histological or cytological confirmation of a solid tumor, and has progressed despite standard therapy, or is intolerant to standard therapy, or has a tumor for which no standard therapy exists or for which standard therapy is not considered adequate. Estimated life expectancy of a minimum of 12 weeks. 4. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1. 5. Female and male subjects should be using adequate contraceptive measures as requested. Exclusion Criteria: 1. Subjects with CNS tumors or known CNS metastases will be excluded. 2. Prior ATG-101 administration or a 4-1BB agonist. 3. Prior anti-tumor systemic therapy within 21 days(a period of 5 'half- lives') of the first dose of study treatment. 4. Radiotherapy with a wide field of radiation within 28 days. 5. With the exception of alopecia, any unresolved toxicities from prior therapy greater than Grade 1 (CTCAE v5.0) at the time of ICF signature. 6. Active infection, including hepatitis B and/or hepatitis C. 7. Have uncontrolled intercurrent illness, including but not limited to: 8. Inadequate bone marrow reserve or organ function. 9. History of hypersensitivity or history of allergic reactions attributed to drugs with a similar chemical or biologic structure or class to ATG-101. 10. Prior organ allograft transplantations. 11. Pregnant or nursing females. 12. Have a history of another primary malignancy within 3 years prior to starting study treatment. Exceptions are as follows: the disease under study; adequately treated basal or squamous cell carcinoma of the skin; cancer of the cervix in situ, etc. 13. In the opinion of the investigator, subject's complications or other conditions may affect protocol compliance or may be unsuitable for participation in the study.
References
Publications (0)
Data not yet available
No reference posted for this study.