Advanced Malignant TumorsPhase 1NCT05082545
Phase I Study of SHR-2002 + SHR-1316 in Patients With Advanced Malignant Tumors
A Phase 1 study testing SHR-2002 and SHR-1316 in people with Advanced Malignant Tumors, run by Atridia Pty Ltd. at 4 sites in Australia.
Trial summary
This is Phase 1 study FIH to check "Dose Escalation, Dose expansion and Indication expansion". This study is AUSTRALIA only study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Malignant Tumors
- What is being tested?
- SHR-2002 and SHR-1316
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 4 sitesAustralia
- Study dates
- 23 Nov 2021to 12 Feb 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Subjects must meet all the following criteria to be eligible for enrollment into the study:
- Ability to understand and voluntarily agrees to participate by giving written informed consent for the study;
- Male or female aged ≥18 years at the time of signing the ICF;
- 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;
- An Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1 (Appendix 2);
- 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:
- Patients with known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
- Patients with tumor-related pain that cannot be controlled as determined by the investigator.
- Systemic anti-tumor therapy within 28 days prior to the first dose of the study treatment
- History of autoimmune diseases, except for Type 1 diabetes (blood glucose can be controlled by insulin therapy)
- History of clinically significant cardiovascular or cerebrovascular diseases within 6 months prior to the first dose of study treatment.
- Known history of serious allergic reactions to the investigational product or its main ingredients;
- History of immunodeficiency, including positive HIV serum test result and other acquired or congenital immunodeficiency diseases, or history of organ transplantation;
Trial locations and contacts
4 sites in 1 country.
Australia4 sites
Icon Cancer Centre
Brisbane, Queensland, 4101
Linear clinical research
Perth, Western Australia, 6009
Scientia Clinical research
Sydney, 2031
Liverpool Hospital
Sydney, 2170
About this study
Official 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
This is Phase 1 study FIH to check "Dose Escalation, Dose expansion and Indication expansion". This study is AUSTRALIA only study.
- Conditions
- Advanced Malignant Tumors
- Being tested
- SHR-2002 and SHR-1316
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-2002 and SHR-1316Drug
Cohort study
| Study group | Role | What they receive |
|---|---|---|
| Dose escalation:SHR-2002+SHR-1316 | Experimental | SHR-2002 +SHR-1316 C1D1 SHR-2002,C1D22 SHR-2002+SHR-1316, C2 SHR-2002+SHR-1316 Receives: Drug: SHR-2002 and SHR-1316 |
| Dose expansion stage: SHR-2002+SHR-1316 | Experimental | Dose expansion of SHR-2002 will be decided after finishing few cohorts in Dose escalation part. Receives: Drug: SHR-2002 and SHR-1316 |
| Indication expansion stage：SHR-2002+SHR-1316 | Experimental | Indication expansion of SHR-2002 will be decided after finishing few cohorts in Dose expansion part. Receives: Drug: SHR-2002 and SHR-1316 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events
Number of subjects with adverse events (AEs)
Measured: Screening up to study completion, an average of 2 years
Number of participants experiencing Dose-Limiting Toxicities (DLTs)
According to National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI-CTCAE v.5.0)
Measured: Up to 42 days
Secondary outcomes (3)
PK of SHR-2002 + SHR-1316
To check Maximum concentration (Cmax)
Measured: Before and after SHR-2002 and SHR-1316 infusion throughout the study, an average of 2 years
PK of SHR-2002 + SHR-1316
To check AUC last
Measured: Before and after SHR-2002 and SHR-1316 infusion throughout the study, an average of 2 years
Immunogenicity of SHR-2002 + SHR-1316
ADA of SHR-2002 + SHR-1316
Measured: Before and after SHR-2002 and SHR-1316 infusion throughout the study, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2021
- Study start23 Nov 2021
- Primary completion17 Jul 2023
- Study completion12 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Malignant TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Atridia Pty Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05082545
- Sponsor's protocol ID
- SHR-2002-102
- Other IDs
- SHR-2002-I-102
- Status last verified
- Dec 2023
- First submitted
- 15 Sep 2021
- Last updated
- 4 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT05082545
- Acronym / sponsor ID
- SHR-2002-102
- Conditions
- Advanced Malignant Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Atridia Pty Ltd.Industry (pharma, biotech, devices)
- Study start
- 23 Nov 2021 (actual)
- Primary completion
- 17 Jul 2023 (actual)
- Study completion
- 12 Feb 2024 (actual)
- First posted
- 19 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is Phase 1 study FIH to check "Dose Escalation, Dose expansion and Indication expansion". This study is AUSTRALIA only study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dose escalation:SHR-2002+SHR-1316 | Experimental | Drug: SHR-2002 and SHR-1316SHR-2002 +SHR-1316 C1D1 SHR-2002,C1D22 SHR-2002+SHR-1316, C2 SHR-2002+SHR-1316 |
| Dose expansion stage: SHR-2002+SHR-1316 | Experimental | Drug: SHR-2002 and SHR-1316Dose expansion of SHR-2002 will be decided after finishing few cohorts in Dose escalation part. |
| Indication expansion stage：SHR-2002+SHR-1316 | Experimental | Drug: SHR-2002 and SHR-1316Indication expansion of SHR-2002 will be decided after finishing few cohorts in Dose expansion part. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SHR-2002 and SHR-1316Cohort study | Drug | Dose escalation:SHR-2002+SHR-1316, Dose expansion stage: SHR-2002+SHR-1316, Indication expansion stage：SHR-2002+SHR-1316 |
Primary outcome
Adverse events
Time frame: Screening up to study completion, an average of 2 years
Number of subjects with adverse events (AEs)
Number of participants experiencing Dose-Limiting Toxicities (DLTs)
Time frame: Up to 42 days
According to National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI-CTCAE v.5.0)
3 secondary outcomes
PK of SHR-2002 + SHR-1316
Time frame: Before and after SHR-2002 and SHR-1316 infusion throughout the study, an average of 2 years
PK of SHR-2002 + SHR-1316
Time frame: Before and after SHR-2002 and SHR-1316 infusion throughout the study, an average of 2 years
Immunogenicity of SHR-2002 + SHR-1316
Time frame: Before and after SHR-2002 and SHR-1316 infusion throughout the study, an average of 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SHR-2002 and SHR-1316 in people with Advanced Malignant Tumors, run by Atridia Pty Ltd. at 4 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events (time frame: Screening up to study completion, an average of 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2024.