A Trial of SHR-1701 in Subjects With Advanced Solid Tumors
- Registration Number
- NCT04324814
- Lead Sponsor
- Atridia Pty Ltd.
- Brief Summary
This is a dose-escalation and dose-expansion Phase 1 trial to evaluate the safety and tolerability of SHR-1701 in subjects with advanced solid tumors.
- Detailed Description
This is a two-part, open-label, multicenter, non-randomized, dose escalation, Phase 1 study of repeated doses of SHR-1701 in subjects with advanced solid tumors who have failed current standard anti-tumor therapies.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 41
- Diagnosed (histologically or cytologically) with solid tumors
- ECOG Performance Status of 0 or 1 at both the screening and baseline visits
- Life expectancy ≥12 weeks
- Adequate laboratory parameters
- Willing and able to comply with clinic visits and study-related procedures
- Provide signed informed consent
- Known history of hypersensitivity to the study drug
- Prior malignancy active within the previous 2 years
- Any investigational or concurrent cancer therapy
- History of immunodeficiency including seropositivity
- Systemic antibiotics treatment for ≥ 7 days before the first dose
- A known history of allogeneic organ transplantation
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Dose level 5 SHR-1701 Subjects will receive a single dose of SHR-1701 at Dose level 3 on Day 1 and Day 15 of each cycle Dose level 1 SHR-1701 Subjects will receive a single dose of SHR-1701 at Dose level 1 on Day 1 of each cycle Dose level 4 SHR-1701 Subjects will receive a single dose of SHR-1701 at Dose level 2 1 on Day 1 and Day 15 of each cycle Dose expansion 1 SHR-1701 Subjects will receive a single dose of SHR-1701 on a selected dose level Day 1 of each cycle Dose expansion 2 SHR-1701 Subjects will receive a single dose of SHR-1701 on a selected dose level on Day 1 of each cycle Dose level 2 SHR-1701 Subjects will receive a single dose of SHR-1701 at Dose level 2 on Day 1 of each cycle Dose level 3 SHR-1701 Subjects will receive a single dose of SHR-1701 at Dose level 3 on Day 1 of each cycle
- Primary Outcome Measures
Name Time Method Vital signs Screening up to study completion, an average of 1 year Incidence of vital sign abnormalities
Adverse events Screening up to study completion, an average of 1 year Number of subjects with adverse events (AEs)
Laboratory results Screening up to study completion, an average of 1 year Number of subjects with laboratory tests findings of potential clinical importance
Electrocardiogram Screening up to study completion, an average of 1 year Number of subjects with clinically significant abnormal ECG QT Interval
- Secondary Outcome Measures
Name Time Method Pharmacokinetic - Cmax Pre-dose, 10min(±2min), 1h(±5min), 2h(±5min), 6h(±10min) Post-dose on Cycle1 Day 1, pre-dose on Day 2, 3, 4, 8, 15 Maximum observed plasma concentration (Cmax) of SHR-1701
Pharmacokinetic - AUC∞ Pre-dose, 10min(±2min), 1h(±5min), 2h(±5min), 6h(±10min) Post-dose on Cycle1 Day 1, pre-dose on Day 2, 3, 4, 8, 15 Area under the concentration-time curve from time 0 to infinity of SHR-1701
Pharmacokinetic - t1/2 Pre-dose, 10min(±2min), 1h(±5min), 2h(±5min), 6h(±10min) Post-dose on Cycle1 Day 1, pre-dose on Day 2, 3, 4, 8, 15 Terminal elimination half-life
Pharmacokinetic - Tmax Pre-dose, 10min(±2min), 1h(±5min), 2h(±5min), 6h(±10min) Post-dose on Cycle1 Day 1, pre-dose on Day 2, 3, 4, 8, 15 Time to Cmax of SHR-1701
Pharmacokinetic - CL/F Pre-dose, 10min(±2min), 1h(±5min), 2h(±5min), 6h(±10min) Post-dose on Cycle1 Day 1, pre-dose on Day 2, 3, 4, 8, 15 Apparent clearance of SHR-1701
Pharmacokinetic - Vz/F Pre-dose, 10min(±2min), 1h(±5min), 2h(±5min), 6h(±10min) Post-dose on Cycle1 Day 1, pre-dose on Day 2, 3, 4, 8, 15 Apparent volume of distribution during terminal phase of SHR-1701
Pharmacodynamics- ADA Pre-dose on Day1 of cycle 2,3,4,5,7,9,13,17 Anti-drug antibody of PD-L1
Trial Locations
- Locations (4)
Linear Clinical Research
🇦🇺Perth, Western Australia, Australia
Icon Cancer Care Centre
🇦🇺South Brisbane, New South Wales, Australia
Scientia Clinical research
🇦🇺Sydney, New South Wales, Australia
Sydney South West Private
🇦🇺Sydney, New South Wales, Australia