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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04324814




Registration number
NCT04324814
Ethics application status
Date submitted
28/11/2019
Date registered
27/03/2020
Date last updated
21/02/2023

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 2 on Day 1 of each cycle

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

Experimental: Dose level 4 - Subjects will receive a single dose of SHR-1701 at Dose level 2 1 on Day 1 and Day 15 of each cycle

Experimental: Dose level 5 - Subjects will receive a single dose of SHR-1701 at Dose level 3 on Day 1 and Day 15 of each cycle

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

Experimental: Dose expansion 2 - Subjects will receive a single dose of SHR-1701 on a selected dose level on Day 1 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
Timepoint [1] 0 0
Screening up to study completion, an average of 1 year
Primary outcome [2] 0 0
Laboratory results
Timepoint [2] 0 0
Screening up to study completion, an average of 1 year
Primary outcome [3] 0 0
Vital signs
Timepoint [3] 0 0
Screening up to study completion, an average of 1 year
Primary outcome [4] 0 0
Electrocardiogram
Timepoint [4] 0 0
Screening up to study completion, an average of 1 year
Secondary outcome [1] 0 0
Pharmacokinetic - Cmax
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
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
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
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
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
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
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
Sex
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
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
31/03/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/02/2023
Sample size
Target
Accrual to date
Final
41
Recruitment in Australia
Recruitment state(s)
NSW,WA
Recruitment hospital [1] 0 0
Icon Cancer Care Centre - South Brisbane
Recruitment hospital [2] 0 0
Scientia Clinical research - Sydney
Recruitment hospital [3] 0 0
Sydney South West Private - Sydney
Recruitment hospital [4] 0 0
Linear Clinical Research - Perth
Recruitment postcode(s) [1] 0 0
4101 - South Brisbane
Recruitment postcode(s) [2] 0 0
- Sydney
Recruitment postcode(s) [3] 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/ct2/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
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries