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A Phase I Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of HS248 in the Treatment of Patients With Advanced Solid Tumors
This study is a non-random, open multi-center study This study is a non-random, open multi-center phase I study, aimed at evaluation period research, aimed at In the evaluation phase study, it aims to evaluate the safety, tolerance PK characteristics and preliminary anti-tumor activity of HS248 in patients with advanced solid tumors. The study was divided into 2 phases, including dose escalation and dose expansion。
Details
| Lead sponsor | Hanhui Pharmaceutical Co., Ltd |
|---|---|
| Phase | Phase 1 |
| Status | UNKNOWN |
| Enrolment | 24 |
| Start date | 2022-11-15 |
| Completion | 2023-12 |
Conditions
- Solid Tumor, Adult
Interventions
- HS248 pieces
Primary outcomes
- Safety and tolerability — From first dose of HS248 through 28 days after the last HS248 treatment (up to 2 years); each cycle is 28 days
To examine the incidence of clinical and laboratory adverse events after multiple doses of HS-248 in the dose escalation and dose expansion phases - MTD and/or RP2DP2D — The end of the study is defined as the last subject completing the last visit, study treatment for 2 years, loss to follow-up, death or withdrawal of informed consent, whichever occurs first
MTD and/or RP2DP2D
Countries
China