drugset / Trial / NCT06028373
A Study of ATG-031 in Advanced Solid Tumors or B-cell Non-Hodgkin Lymphomas
Non-randomizedSequentialOpen-labelTreatment
Summary
ATG-031 study (alias: PERFORM) is a multicenter, open-label, Phase 1 study of ATG-031 in patients with advanced solid tumors or B-NHL. The study design includes a Dose Escalation Phase and a Dose Expansion Phase, and will enroll patients with advanced solid tumors (i.e., preferred tumor types) or relapsed/refractory (R/R) B-NHLs. The study's primary objective is to evaluate the safety and tolerability of ATG-031 and determine the RP2D（Refered Phase II dose） of ATG-031.
Timeline
- Start
- 2023-12-08
- Primary completion
- 2026-04-08
- Completion
- 2026-06-12
Outcome
Outcome not reported
Stopped (Business): “The study was terminated because of sponsor's development strategy change”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | ATG-031 | Unknown | 0.03 mg/kg | Intravenous |
| Comparator | ATG-031 | Unknown | 0.1 mg/kg | Intravenous |
| Comparator | ATG-031 | Unknown | 0.3 mg/kg | Intravenous |
| Comparator | ATG-031 | Unknown | 1 mg/kg | Intravenous |
| Comparator | ATG-031 | Unknown | 2 mg/kg | Intravenous |
| Comparator | ATG-031 | Unknown | 4 mg/kg | Intravenous |
| Comparator | ATG-031 | Unknown | 6 mg/kg | Intravenous |
| Comparator | ATG-031 | Unknown | 9 mg/kg | Intravenous |