Advanced Solid TumoursPhase 1NCT05154604
A Study of SHR-A1921 for Injection in Subjects With Advanced Solid Tumours
A Phase 1 study testing SHR-A1921 in people with Advanced Solid Tumours, run by Suzhou Suncadia Biopharmaceuticals Co., Ltd..
Trial summary
To assess the safety and tolerability of SHR-A1921 in patients with advanced solid tumours, to determine the dose-limiting toxicity (DLT), maximum tolerated dose (MTD), and/or recommended phase II dose (RP2D) of SHR-A1921 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumours
- What is being tested?
- SHR-A1921
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- No sites listed yet
- Study dates
- 31 Dec 2021to 31 Aug 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
Who may be able to join
- Voluntary participation and written informed consent；
- Aged 18-75 years (inclusive), males and females;
- Consents to provide tumor tissue samples;
- Subjects must have histologically or clinically confirmed advanced and/or metastatic malignancies for which failure of standard treatment or lack of effective standard treatment;
- At least one measurable lesion according to RECIST v1.1;
- ECOG score of 0-1;
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- Expected survival ≥ 12 weeks;
- Adequate bone marrow reserve and organ function ；
- For female patients of childbearing potential or male patients with partners of childbearing potential who are not sterilized by surgical operations, they are required to use a medically approved contraceptive measure during the study treatment period and within 3 months after the end of the study treatment; For female patients of childbearing potential who are not sterilized by surgical operations, they must have a negative serum HCG test result within 72 h prior to study enrollment; and they must not be in the lactation period;
Who cannot join
- Known and untreated central nervous system (CNS) or leptomeningeal metastases;
- Macrovascular invasion based on imaging;
- Cancerous ascites, pleural effusion or pericardial effusion with clinical symptoms;
- Has a history of a second malignancy;
- History of immunodeficiency disease or organ transplant;
- Uncontrolled cardiac diseases or symptoms;
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- Has a history of non-infectious ILD/pneumonitis that required steroids, or has current ILD/pneumonitis;
- Has a history of active chronic enteritis 6 weeks prior to the initiation of the study treatment or intestinal obstruction, gastrointestinal perforation 3 months prior to the initiation of the study treatment;
- Has a history of Grade≥2 bleeding 4 weeks prior to the initiation of the study treatment or is current receiving anticoagulation therapy;
- Subjects with active hepatitis B or active hepatitis C;
- Subjects who have received systemic anti-tumor treatments 4 weeks prior to the initiation of the study treatment.
- Has unresolved toxicities from previous anticancer therapy.
- Has a history of severe hypersensitivity reactions to either the drug substances or inactive ingredients of SHR-A1921;
- Subjects with other potential factors that may affect the study results or result in the premature discontinuation as determined by the investigator, such as alcoholism, drug abuse, other serious diseases (including mental illness) requiring concomitant treatment, serious laboratory abnormalities, or family or social factors that could affect the safety of the patients.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Phase 1 Multi-Center, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of SHR-A1921 in Subjects With Advanced Malignant Solid Tumour .
To assess the safety and tolerability of SHR-A1921 in patients with advanced solid tumours, to determine the dose-limiting toxicity (DLT), maximum tolerated dose (MTD), and/or recommended phase II dose (RP2D) of SHR-A1921
- Conditions
- Advanced Solid Tumours
- Being tested
- SHR-A1921
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-A1921Drug
Treatment group: Subjects will receive an intravenous infusion of SHR-A1921 in a dose escalation until confirmed progression, unaccepted toxicity, or any criterion for withdrawal from the study.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group: SHR-A1921 | Experimental | Not described Receives: Drug: SHR-A1921 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose Limited Toxicity (DLT)
Measured: 21 Days (first cycle)
Maximum Tolerable Dose (MTD)
Measured: 21 Days (first cycle)
Recommended phase II dose (RP2D)
Measured: Screening up to dose escalation and expansion study completion, appropriately to 1 year
Adverse Events
Incidence and grade of adverse events as assessed by CTCAE v5.0
Measured: Screening up to study completion, an average of 1 year
Secondary outcomes (17)
Time to reach maximum concentration (Tmax) of SHR-A1921、total antibody
Measured: Screening up to end of treatment, an average of 1 year
Maximum concentration (Cmax) of SHR-A1921、total antibody
Measured: Screening up to end of treatment, an average of 1 year
Area under the concentration-time curve from time zero to the time of the last quantifiable time point t (AUC0-t) of SHR-A1921、total antibody
Measured: Screening up to end of treatment, an average of 1 year
Area under the concentration-time curve from time 0 extrapolated to infinity (AUC0-t) of SHR-A1921、total antibody
Measured: Screening up to end of treatment, an average of 1 year
Terminal half-life (t1/2) of SHR-A1921、total antibody
Measured: Screening up to end of treatment, an average of 1 year
Total body clearance (CL) of SHR-A1921、total antibody
Measured: Screening up to end of treatment, an average of 1 year
Volume of distribution at steady state (Vss) of SHR-A1921、total antibody
Measured: Screening up to end of treatment, an average of 1 year
Mean residence time (MRT) of SHR-A1921、total antibody
Measured: Screening up to end of treatment, an average of 1 year
Maximum steady-state drug concentration during a dosage interval (Css, max) of SHR-A1921、total antibody
Measured: Screening up to end of treatment, an average of 1 year
Minimum steady-state drug concentration during a dosage interval (Css, min) of SHR-A1921、total antibody
Measured: Screening up to end of treatment, an average of 1 year
Accumulation ratio (Rac) of SHR-A1921、total antibody
Measured: Screening up to end of treatment, an average of 1 year
Anti-drug antibody(ADA) level of SHR-A1921
Measured: Screening up to 90 days after the last dose, an average of 1 year
Objective Response Rate (ORR) assessed by site investigator as per RECIST 1.1
Measured: Screening up to study completion, an average of 1 year
Duration of Response (DoR) assessed by site investigator as per RECIST 1.1
Measured: Screening up to study completion, an average of 1 year
Disease Control Rate (DCR) assessed by site investigator as per RECIST 1.1
Measured: Screening up to study completion, an average of 1 year
Progression-Free Survival (PFS) assessed by site investigator as per RECIST 1.1
Measured: Screening up to study completion, an average of 1 year
Overall Survival (OS)
Measured: Screening up to study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2021
- Study start31 Dec 2021 (estimated)
- Primary completion31 Aug 2024 (estimated)
- Study completion31 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumoursStudies of the same condition, open and under way.
- More trials run by Suzhou Suncadia Biopharmaceuticals Co., Ltd.The sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 156 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05154604
- Sponsor's protocol ID
- SHR-A1921-I-101
- Status last verified
- Nov 2021
- First submitted
- 12 Nov 2021
- Last updated
- 13 Dec 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Multi-Center, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of SHR-A1921 in Subjects With Advanced Malignant Solid Tumour .
- ClinicalTrials.gov ID
- NCT05154604
- Acronym / sponsor ID
- SHR-A1921-I-101
- Conditions
- Advanced Solid Tumours
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 156 participants (estimated)
- Lead sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 31 Dec 2021 (estimated)
- Primary completion
- 31 Aug 2024 (estimated)
- Study completion
- 31 Aug 2024 (estimated)
- First posted
- 13 Dec 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.
To assess the safety and tolerability of SHR-A1921 in patients with advanced solid tumours, to determine the dose-limiting toxicity (DLT), maximum tolerated dose (MTD), and/or recommended phase II dose (RP2D) of SHR-A1921
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment group: SHR-A1921 | Experimental | Drug: SHR-A1921 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Voluntary participation and written informed consent；
- Aged 18-75 years (inclusive), males and females;
- Consents to provide tumor tissue samples;
- Subjects must have histologically or clinically confirmed advanced and/or metastatic malignancies for which failure of standard treatment or lack of effective standard treatment;
- At least one measurable lesion according to RECIST v1.1;
Key exclusion criteria (14 listed)
- Known and untreated central nervous system (CNS) or leptomeningeal metastases;
- Macrovascular invasion based on imaging;
- Cancerous ascites, pleural effusion or pericardial effusion with clinical symptoms;
- Has a history of a second malignancy;
- History of immunodeficiency disease or organ transplant;
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-A1921Treatment group: Subjects will receive an intravenous infusion of SHR-A1921 in a dose escalation until confirmed progression, unaccepted toxicity, or any criterion for withdrawal from the study. | Drug | Treatment group: SHR-A1921 |
Primary outcome
Dose Limited Toxicity (DLT)
Time frame: 21 Days (first cycle)
Maximum Tolerable Dose (MTD)
Time frame: 21 Days (first cycle)
Recommended phase II dose (RP2D)
Time frame: Screening up to dose escalation and expansion study completion, appropriately to 1 year
Adverse Events
Time frame: Screening up to study completion, an average of 1 year
Incidence and grade of adverse events as assessed by CTCAE v5.0
17 secondary outcomes
Time to reach maximum concentration (Tmax) of SHR-A1921、total antibody
Time frame: Screening up to end of treatment, an average of 1 year
Maximum concentration (Cmax) of SHR-A1921、total antibody
Time frame: Screening up to end of treatment, an average of 1 year
Area under the concentration-time curve from time zero to the time of the last quantifiable time point t (AUC0-t) of SHR-A1921、total antibody
Time frame: Screening up to end of treatment, an average of 1 year
Area under the concentration-time curve from time 0 extrapolated to infinity (AUC0-t) of SHR-A1921、total antibody
Time frame: Screening up to end of treatment, an average of 1 year
Terminal half-life (t1/2) of SHR-A1921、total antibody
Time frame: Screening up to end of treatment, an average of 1 year
Total body clearance (CL) of SHR-A1921、total antibody
Time frame: Screening up to end of treatment, an average of 1 year
Volume of distribution at steady state (Vss) of SHR-A1921、total antibody
Time frame: Screening up to end of treatment, an average of 1 year
Mean residence time (MRT) of SHR-A1921、total antibody
Time frame: Screening up to end of treatment, an average of 1 year
Maximum steady-state drug concentration during a dosage interval (Css, max) of SHR-A1921、total antibody
Time frame: Screening up to end of treatment, an average of 1 year
Minimum steady-state drug concentration during a dosage interval (Css, min) of SHR-A1921、total antibody
Time frame: Screening up to end of treatment, an average of 1 year
Accumulation ratio (Rac) of SHR-A1921、total antibody
Time frame: Screening up to end of treatment, an average of 1 year
Anti-drug antibody(ADA) level of SHR-A1921
Time frame: Screening up to 90 days after the last dose, an average of 1 year
Objective Response Rate (ORR) assessed by site investigator as per RECIST 1.1
Time frame: Screening up to study completion, an average of 1 year
Duration of Response (DoR) assessed by site investigator as per RECIST 1.1
Time frame: Screening up to study completion, an average of 1 year
Disease Control Rate (DCR) assessed by site investigator as per RECIST 1.1
Time frame: Screening up to study completion, an average of 1 year
Progression-Free Survival (PFS) assessed by site investigator as per RECIST 1.1
Time frame: Screening up to study completion, an average of 1 year
Overall Survival (OS)
Time frame: Screening up to study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2021.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SHR-A1921 in people with Advanced Solid Tumours, run by Suzhou Suncadia Biopharmaceuticals Co., Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 14 exclusion criteria. 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: status not confirmed, as of the sponsor's last update on 13 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Quanren Wang, Ph.D (86-021-61053363, quanren.wang@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose Limited Toxicity (DLT) (time frame: 21 Days (first cycle)). The study lists 4 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 13 Dec 2021.