Trials / Unknown
UnknownNCT05058352
A Study of HS269 in Patients With Advanced Solid Tumors
A Phase I, Open-label，Dose-escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of HS269, in Patients With Advanced Solid Tumor
- Status
- Unknown
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 36 (estimated)
- Sponsor
- Zhejiang Hisun Pharmaceutical Co. Ltd. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a Phase I, open-label, first in human study of HS269 tablet, a small molecule highly-selective RET Inhibitor. The dose-escalation study will assess the safety, tolerability, and pharmacokinetics of HS269 and determine the dose and schedule to be used in Phase II. Seventeen to thirty-six patients with advanced solid tumor may be enrolled in this study.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | HS269 | Oral tablets, once daily. Dose escalation from 50 mg QD, through 100 mg, 200mg, 300 mg, 400 mg, to 500mg. |
Timeline
- Start date
- 2021-10-01
- Primary completion
- 2022-10-01
- Completion
- 2023-04-01
- First posted
- 2021-09-27
- Last updated
- 2021-09-27
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT05058352. Inclusion in this directory is not an endorsement.