Trials / Unknown
UnknownNCT05770310
A Phase I Study Of JS015 in Patients With Advanced Solid Tumors
A Phase I Study to Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of JS015 In Patients With Advanced Solid Tumors
- Status
- Unknown
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 114 (estimated)
- Sponsor
- Shanghai Junshi Bioscience Co., Ltd. · Academic / Other
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
This is a Phase I open-label, multicenter study to evaluate the safety, tolerability, pharmacokinetics (PK), immunogenicity and antitumor activity of JS015 in patients with advanced solid tumors. The Recommended dose for phase II trial （RP2D） was determined based on the safety, pharmacokinetics, and initial efficacy data of the dose escalation and extension.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | JS015 | Patient receives specific dose of JS015. The administration method of JS015 is intravenous infusion. |
Timeline
- Start date
- 2023-02-01
- Primary completion
- 2024-06-01
- Completion
- 2025-07-01
- First posted
- 2023-03-15
- Last updated
- 2023-03-15
Locations
4 sites across 1 country: China
Source: ClinicalTrials.gov record NCT05770310. Inclusion in this directory is not an endorsement.