Trials / Suspended
SuspendedNCT03722186
Safety, Tolerability and Pharmacokinetics/Pharmacodynamics (PK/PD) of SHR-1603 in Subjects With Advanced Malignancies
An Open-label, Single-arm, Phase I Study of the Safety, Tolerability and Pharmacokinetic/Pharmacodynamic Characteristics of SHR-1603 in Subjects With Advanced Solid Tumor or Relapsed/Refractory Lymphoma
- Status
- Suspended
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 128 (estimated)
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
SHR-1603-I-101 is an single-arm, open-label, dose finding phase I clinical trial of SHR-1603 in subjects with advanced solid tumor or relapsed/refractory malignant lymphoid diseases. The study drug will be administered by intravenous infusion.
Detailed description
SHR-1603-I-101 is a single-arm, open-label, dose finding, first-in-human(FIH) clinical trial of SHR-1603 intravenous infusion in subjects with advanced solid tumor or relapsed/refractory malignant lymphoid diseases. The primary objective of this study is to evaluate the safety and tolerability of SHR-1603, as well as to determine the maximally tolerated dose(MTD) and define the recommended Phase 2 dose(RP2D) of SHR-1603. The study is consisted of a dose-escalation Part 1 followed by a dose expansion Part 2 and a clinical expansion Part 3. Part 1 will use accelerated titration and 3+3 dose-escalation design to determine MTD. Part 2 will further evaluate the safety, tolerability and PK/PD features of SHR-1603 based on the results of Part 1. Part 3 will include several cohorts of malignancies to collect preliminary efficacy information of SHR-1603.
Conditions
- Physiological Effects of Drugs
- Neoplasms by Histologic Type
- Lymphoma
- Hematologic Neoplasms
- Immunotherapy
- Advanced Cancer
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | SHR-1603 | SHR-1603 monotherapy |
Timeline
- Start date
- 2018-11-13
- Primary completion
- 2019-04-04
- Completion
- 2021-10-01
- First posted
- 2018-10-26
- Last updated
- 2021-03-22
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT03722186. Inclusion in this directory is not an endorsement.