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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/NCT05082545




Registration number
NCT05082545
Ethics application status
Date submitted
15/09/2021
Date registered
19/10/2021
Date last updated
4/06/2024

Titles & IDs
Public title
Phase I Study of SHR-2002 + SHR-1316 in Patients With Advanced Malignant Tumors
Scientific title
A Phase I Clinical Study on the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of SHR-2002 Injection in Combination With SHR-1316 in Patients With Advanced Malignant Tumors
Secondary ID [1] 0 0
SHR-2002-I-102
Secondary ID [2] 0 0
SHR-2002-102
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced Malignant Tumors 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - SHR-2002 and SHR-1316

Experimental: Dose escalation:SHR-2002+SHR-1316 - SHR-2002 +SHR-1316 C1D1 SHR-2002,C1D22 SHR-2002+SHR-1316, C2 SHR-2002+SHR-1316

Experimental: Dose expansion stage: SHR-2002+SHR-1316 - Dose expansion of SHR-2002 will be decided after finishing few cohorts in Dose escalation part.

Experimental: Indication expansion stage:SHR-2002+SHR-1316 - Indication expansion of SHR-2002 will be decided after finishing few cohorts in Dose expansion part.


Treatment: Drugs: SHR-2002 and SHR-1316
Cohort study
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 2 years
Primary outcome [2] 0 0
Number of participants experiencing Dose-Limiting Toxicities (DLTs)
Timepoint [2] 0 0
Up to 42 days
Secondary outcome [1] 0 0
PK of SHR-2002 + SHR-1316
Timepoint [1] 0 0
Before and after SHR-2002 and SHR-1316 infusion throughout the study, an average of 2 years
Secondary outcome [2] 0 0
PK of SHR-2002 + SHR-1316
Timepoint [2] 0 0
Before and after SHR-2002 and SHR-1316 infusion throughout the study, an average of 2 years
Secondary outcome [3] 0 0
Immunogenicity of SHR-2002 + SHR-1316
Timepoint [3] 0 0
Before and after SHR-2002 and SHR-1316 infusion throughout the study, an average of 2 years

Eligibility
Key inclusion criteria
Subjects must meet all the following criteria to be eligible for enrollment into the study:

1. Ability to understand and voluntarily agrees to participate by giving written informed
consent for the study;

2. Male or female aged =18 years at the time of signing the ICF;

3. Histopathologically or cytologically documented advanced or metastatic malignancies
and failed or intolerable to previous standard therapy, has no available standard of
care therapy or refused standard therapy;

4. An Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1
(Appendix 2);

5. Female and male patients of reproductive potential must agree to use highly effective
contraception during the study treatment period and within 6 months after the last
investigational drug administration.

Subjects who meet any of the following criteria will be excluded from the study:

1. Patients with known active central nervous system (CNS) metastases and/or
carcinomatous meningitis.

2. Patients with tumor-related pain that cannot be controlled as determined by the
investigator.

3. Systemic anti-tumor therapy within 28 days prior to the first dose of the study
treatment

4. History of autoimmune diseases, except for Type 1 diabetes (blood glucose can be
controlled by insulin therapy)

5. History of clinically significant cardiovascular or cerebrovascular diseases within 6
months prior to the first dose of study treatment.

6. Known history of serious allergic reactions to the investigational product or its main
ingredients;

7. History of immunodeficiency, including positive HIV serum test result and other
acquired or congenital immunodeficiency diseases, or history of organ transplantation;
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

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
Parallel
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
23/11/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
12/02/2024
Sample size
Target
Accrual to date
Final
19
Recruitment in Australia
Recruitment state(s)
QLD,WA
Recruitment hospital [1] 0 0
Icon Cancer Centre - Brisbane
Recruitment hospital [2] 0 0
Linear clinical research - Perth
Recruitment hospital [3] 0 0
Scientia Clinical research - Sydney
Recruitment hospital [4] 0 0
Liverpool Hospital - Sydney
Recruitment postcode(s) [1] 0 0
4101 - Brisbane
Recruitment postcode(s) [2] 0 0
6009 - Perth
Recruitment postcode(s) [3] 0 0
2031 - Sydney
Recruitment postcode(s) [4] 0 0
2170 - Sydney

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

Ethics approval
Ethics application status

Summary
Brief summary
This is Phase 1 study FIH to check "Dose Escalation, Dose expansion and Indication
expansion". This study is AUSTRALIA only study.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05082545
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05082545