Trials / Unknown
UnknownNCT03774979
SHR-1701 in Subjects With Metastatic or Locally Advanced Solid Tumors
A Phase I, Open-label Trial to Investigate the Safety, Tolerability, Pharmacokinetics, Biological and Clinical Activity of SHR-1701 in Subjects With Metastatic or Locally Advanced Solid Tumors With Expansion to Selected Indications
- Status
- Unknown
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 193 (actual)
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
The main purpose of this study is to assess the safety and tolerability of SHR-1701 at different dose levels. Study consists of dose-escalation part and an expansion part in subjects with metastatic or locally advanced solid tumors.
Detailed description
This is a Phase I, open-label, multiple-ascending dose trial. Study consists of dose-escalation part in subjects with metastatic or locally advanced solid tumors, and expansion part with selected indications.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | SHR-1701 | Subjects will receive an intravenous infusion of SHR-1701 in a pre-set dose escalation until confirmed progression, unaccepted toxicity, or any criterion for withdrawal from the trial. |
Timeline
- Start date
- 2019-01-24
- Primary completion
- 2023-03-01
- Completion
- 2023-12-01
- First posted
- 2018-12-13
- Last updated
- 2022-11-08
Locations
16 sites across 1 country: China
Source: ClinicalTrials.gov record NCT03774979. Inclusion in this directory is not an endorsement.