Trials / Unknown
UnknownNCT04956926
Clinical Study of JS201 in Patients With Advanced Malignant Tumors
An Open-label, First-in-human, Dose Escalation and Expansion Phase I Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetic Profile of JS201 in Patients With Advanced Malignant Tumors
- Status
- Unknown
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 244 (estimated)
- Sponsor
- Shanghai Junshi Bioscience Co., Ltd. · Academic / Other
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
This is an open label, phase I clinical study to evaluate the safety, tolerability, pharmacokinetic (PK) profile, pharmacodynamic (PD) profile, immunogenicity and preliminary efficacy of JS201 in the patients with advanced malignant tumors who have progression after or during the standard of care, or no effective standard therapeutic regimen. This study is divided into three phases: dose-escalation phase, dose expansion phase, and clinical expansion phase.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | JS201 | JS201 is administered intravenously Q3W at the corresponding dose. |
Timeline
- Start date
- 2021-07-29
- Primary completion
- 2023-07-07
- Completion
- 2023-07-07
- First posted
- 2021-07-09
- Last updated
- 2022-04-11
Locations
21 sites across 1 country: China
Source: ClinicalTrials.gov record NCT04956926. Inclusion in this directory is not an endorsement.