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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT04324814




Registration number
NCT04324814
Ethics application status
Date submitted
28/11/2019
Date registered
27/03/2020
Date last updated
13/04/2020

Titles & IDs
Public title
A Trial of SHR-1701 in Subjects With Advanced Solid Tumors
Scientific title
A Phase 1, Open-Label, Multi-Center, Non-Randomized, Dose Escalation/Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Immunogenicity of SHR-1701 in Subjects With Advanced Solid Tumors
Secondary ID [1] 0 0
SHR-1701-001AUS
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced Solid Tumor 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - SHR-1701

Experimental: Dose level 1 - Subjects will receive a single dose of SHR-1701 at Dose level 1 on Day 1 of each cycle

Experimental: Dose level 2 - Subjects will receive a single dose of SHR-1701 at Dose level 1 on Day 1 of each cycle

Experimental: Dose level 3 - Subjects will receive a single dose of SHR-1701 at Dose level 1 on Day 1 of each cycle

Experimental: Dose level 4 - Subjects will receive a single dose of SHR-1701 at Dose level 1 on Day 1 and Day 15 of each cycle


Treatment: Drugs: SHR-1701
Anti-PD-L1/TGFß fusion protein

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Adverse events - Number of subjects with adverse events (AEs)
Timepoint [1] 0 0
Screening up to study completion, an average of 1 year
Primary outcome [2] 0 0
Laboratory results - Number of subjects with laboratory tests findings of potential clinical importance
Timepoint [2] 0 0
Screening up to study completion, an average of 1 year
Primary outcome [3] 0 0
Vital signs - Incidence of vital sign abnormalities
Timepoint [3] 0 0
Screening up to study completion, an average of 1 year
Primary outcome [4] 0 0
Electrocardiogram - Number of subjects with clinically significant abnormal ECG QT Interval
Timepoint [4] 0 0
Screening up to study completion, an average of 1 year
Secondary outcome [1] 0 0
Pharmacokinetic - Cmax - Maximum observed plasma concentration (Cmax) of SHR-1701
Timepoint [1] 0 0
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
Secondary outcome [2] 0 0
Pharmacokinetic - AUC8 - Area under the concentration-time curve from time 0 to infinity of SHR-1701
Timepoint [2] 0 0
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
Secondary outcome [3] 0 0
Pharmacokinetic - Tmax - Time to Cmax of SHR-1701
Timepoint [3] 0 0
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
Secondary outcome [4] 0 0
Pharmacokinetic - CL/F - Apparent clearance of SHR-1701
Timepoint [4] 0 0
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
Secondary outcome [5] 0 0
Pharmacokinetic - Vz/F - Apparent volume of distribution during terminal phase of SHR-1701
Timepoint [5] 0 0
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
Secondary outcome [6] 0 0
Pharmacokinetic - t1/2 - Terminal elimination half-life
Timepoint [6] 0 0
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
Secondary outcome [7] 0 0
Pharmacodynamics- ADA - Anti-drug antibody of PD-L1
Timepoint [7] 0 0
Pre-dose on Day1 of cycle 2,3,4,5,7,9,13,17

Eligibility
Key inclusion criteria
- 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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- 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
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,WA
Recruitment hospital [1] 0 0
Icon Cancer Care Centre - South Brisbane
Recruitment hospital [2] 0 0
Linear Clinical Research - Perth
Recruitment postcode(s) [1] 0 0
4101 - South Brisbane
Recruitment postcode(s) [2] 0 0
- Perth

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Atridia Pty Ltd.
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT04324814
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Kathy You, PhD
Address 0 0
Country 0 0
Phone 0 0
+61 02 9299 0433
Fax 0 0
Email 0 0
kathyyou@atridia.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT04324814