Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT04324814