Evaluate the Safety and Clinical Activity of HH2853
This is an open-label, multicenter, first-in-human phase I/II study which is composed of 3 parts: phase I dose escalation, phase I dose extension and phase II. HH2853 will be administered orally on a continuous BID schedule on a continuous 28-day treatment cycle.
| Condition(s) | FL Lymphoma, Epithelioid Sarcoma, Peripheral T Cell Lymphoma, Advanced Solid Tumor |
|---|---|
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Study type | Interventional |
| Summary | This is an open-label, multicenter, first-in-human phase I/II study which is composed of 3 parts: phase I dose escalation, phase I dose extension and phase II. HH2853 will be administered orally on a continuous BID schedule on a continuous 28-day treatment cycle. |
| Who can participate | Inclusion criteria: 1. Provided signed written informed consent prior to initiation of any study-related procedures; 2. Males and females ≥ 18years of age at the time of consent are obtained (or meet the country's regulatory defined adult legal age); 3. Tumor type criteria: The specific requirements for specific subtypes of recurrent/refractory non Hodgkin's lymphoma (NHL) confirmed by histology are as follows: Histologically confirmed follicular lymphoma (FL) that has been treated with at least two lines of systemic therapy (at least one regimen based on anti-CD20 monoclonal antibodies) according to GELF criteria or as determined by researchers (Grade 1-3a); Relapsed/refractory diffuse large B-cell lymphoma - non-specific (DLBCL NOS, 2016 World Health Organization Lymphoma Classification) |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Haihe Biopharma Co., Ltd. |
| Locations | Phoenix, Arizona, United States; Jacksonville, Florida, United States; Rochester, Minnesota, United States; San Antonio, Texas, United States; Hefei, Anhui, China; Beijing, Beijing Municipality, China (+19 more sites) |
| Start date | 2020-09-08 |
| NCT ID | NCT04390737 |
| Official listing | https://clinicaltrials.gov/study/NCT04390737 |