Trials / Terminated
TerminatedNCT04601285
A Phase I Study of JS108 in Patients With Advanced Solid Tumors
A Phase I, Open-label, First-in-human, Dose Escalation and Expansion Study to Evaluate the Safety, Tolerability and Pharmacokinetic Profile of Recombinant Humanized Anti-Trop2 mAb-Tub196 Conjugate in Patients With Advanced Solid Tumors.
- Status
- Terminated
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 25 (actual)
- 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, first-in-human clinical study designed to evaluate the safety, tolerability, PK profile and efficacy of JS108 for patients with advanced solid tumors. This study is divided into 3 periods: dose escalation period, dose expansion period, and clinical expansion period.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | JS108 (recombinant humanized anti-Trop2 mAb-Tub196 conjugate for injection) | Dose escalation period: JS108 is administered intravenously every three weeks (Q3W) at the dose corresponding to the enrolled dose cohort. Dose expansion period: JS108 is administered intravenously Q3W at the corresponding dose. Clinical expansion period: JS108 is administered intravenously Q3W at the recommended dose. |
Timeline
- Start date
- 2020-10-28
- Primary completion
- 2023-06-14
- Completion
- 2023-06-14
- First posted
- 2020-10-23
- Last updated
- 2023-07-06
Locations
3 sites across 1 country: China
Source: ClinicalTrials.gov record NCT04601285. Inclusion in this directory is not an endorsement.