A Trial to Evaluate Safety and Tolerability of SHR-1316 in Cancer Patients
- Registration Number
- NCT03133247
- Lead Sponsor
- Atridia Pty Ltd.
- Brief Summary
In many types of human tumors, PD-L1 is highly expressed. Such high expression has often been associated with poor prognosis in cancer patients. SHR-1316 is a humanized IgG4 monoclonal antibody that binds specifically to human PD-L1.
- Detailed Description
This is a two-part, open-label, multicenter, non-randomized, dose escalation, Phase I study of repeated doses of SHR-1316 in subjects with advanced or metastatic solid tumors who have failed current standard anti-tumor therapies.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 37
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description SHR-1316 dose-escalation SHR-1316 SHR-1316 doses will be escalated sequentially in 5 cohorts.
- Primary Outcome Measures
Name Time Method Adverse events (AEs) Up to 3 weeks Incidence of treatment-related AEs
Laboratory parameters Up to 3 weeks Incidence of clinically significant laboratory abnormalities
Vital sign values Up to 3 weeks Incidence of clinically significant vital sign abnormalities
ECG values Up to 3 weeks Incidence of clinically significant ECG abnormalities
Dose-limiting toxicities (DLTs) Up to 3 weeks Number of participants with DLTs
- Secondary Outcome Measures
Name Time Method t1/2 Cycle 1 Day 1 (pre-dose and 5 min, 1 hr, 2 hr, and 6 hr post-dose), Day 2, Day 3, Day 4, Day 8, Day 15, Day 22; Day 1 from Cycle 2 onwards (pre-dose and 5-min post-dose) Observed terminal half-life
Tmax Cycle 1 Day 1 (pre-dose and 5 min, 1 hr, 2 hr, and 6 hr post-dose), Day 2, Day 3, Day 4, Day 8, Day 15, Day 22; Day 1 from Cycle 2 onwards (pre-dose and 5-min post-dose) Time to maximum plasma concentration
Cmax Cycle 1 Day 1 (pre-dose and 5 min, 1 hr, 2 hr, and 6 hr post-dose), Day 2, Day 3, Day 4, Day 8, Day 15, Day 22; Day 1 from Cycle 2 onwards (pre-dose and 5-min post-dose) Maximum plasma drug concentration
AUC Cycle 1 Day 1 (pre-dose and 5 min, 1 hr, 2 hr, and 6 hr post-dose), Day 2, Day 3, Day 4, Day 8, Day 15, Day 22; Day 1 from Cycle 2 onwards (pre-dose and 5-min post-dose) Area under the time-concentration curve
Receptor occupancy Cycle 1 Day 1 (pre-dose, 1 hr post-dose); Cycle 1 Day 4; Cycle 1 Day 8; Cycle 1 Day 15; Cycle 2 Day 1; Cycle 3 Day 1 PD-1 receptor occupancy in blood
Immunogenicity Cycle 1 Day 1 (pre-dose), Cycle 1 Day 8, Cycle 1 Day 15; pre-dose on Day 1 of Cycle 2 onwards Incidence of anti-SHR-1316 antibodies
Trial Locations
- Locations (1)
Linear Clinical Research
🇦🇺Perth, West Australia, Australia