Trials / Active Not Recruiting
Active Not RecruitingNCT04322006
A Phase I/II Study of TJ004309 for Advanced Solid Tumor
A Phase I/II Study of Evaluating the Safety, Tolerance, Pharmacokinetics, Pharmacodynamics and Curative Effect of Dose Escalation and Extension for Single Drug TJ004309 and Toripalimab Combine Treatment for Advanced Solid Tumor
- Status
- Active Not Recruiting
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 376 (estimated)
- Sponsor
- TJ Biopharma Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study is a phase I/II study of single drug TJ004309 and Toripalimab combine treatment for Advanced solid tumor. This study include two stages. First stage is dose escalation and second stage is dose extension. The purpose of part A is to confirm the MTD or MED and the clinical dose. The purpose of part B is to observe the safety, effectiveness, Pharmacokinetics, pharmacodynamics and biomarker properties for effective subjects.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | TJ004309 | Antibody to CD73 |
| DRUG | Toripalimab | Humanized monoclonal antibody to PD-1 |
Timeline
- Start date
- 2020-05-09
- Primary completion
- 2025-12-30
- Completion
- 2025-12-30
- First posted
- 2020-03-26
- Last updated
- 2025-05-22
Locations
23 sites across 1 country: China
Source: ClinicalTrials.gov record NCT04322006. Inclusion in this directory is not an endorsement.