Advanced Malignant TumorsPhase 1NCT05193721
A Clinical Study of the Safety and Tolerability of SHR-1901 in Subjects With Advanced Malignant Tumors
A Phase 1 study testing SHR-1901 in people with Advanced Malignant Tumors, run by Suzhou Suncadia Biopharmaceuticals Co., Ltd. at 1 site in China.
Trial summary
The study is being conducted to evaluate the efficacy, and safety of SHR-1901 in subjects with advanced malignant tumors.To explore the reasonable dosage of SHR-1901. 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-1901
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteChina
- Study dates
- 10 Feb 2022to 2 Apr 2025
- 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
- Patients with advanced malignant tumors confirmed pathologically;
- Failure of adequate standard treatment, or no effective standard treatment;
- The expected survival period is more than 3 months;
- The Eastern Cooperative Oncology Group (ECOG) physical fitness score is 0 - 1;
- Have sufficient bone marrow and organ function (have not received blood transfusion or hematopoietic stimulating factor treatment within 14 days):(1)Neutrophil count (ANC) ≥ 1.5×10e9/L; (2)Platelet count (PLT) ≥90×10e9/L; (3)Hemoglobin (Hb) ≥ 9.0g/dL; (4)Serum creatinine ≤1.5 times the upper limit of normal (ULN) or creatinine clearance ≥60 ml/min (calculated using Cockcroft-Gault formula); (5)Total bilirubin (BIL) ≤1.5 times the upper limit of normal (ULN), patients with liver cancer/liver metastasis should be ≤2×ULN; (6)Aspartate aminotransferase (AST/SGOT) and alanine aminotransferase (ALT/SGPT) levels ≤ 3 times the upper limit of normal (ULN), patients with liver cancer/liver metastasis ≤ 5×ULN; (7)International normalized ratio (INR) ≤ 1.5, prothrombin time (PT) and activated partial thromboplastin time (APTT) ≤ 1.5 times ULN;
- Female subjects of childbearing age must undergo a serum pregnancy test within 3 days before starting the study medication, and the result is negative, and are willing to use a medically approved high-efficiency contraception during the study period and within 6 months after the last administration of the study drug Measures: For male subjects whose partners are females of childbearing age, they should be surgically sterilized, or agree to use effective methods of contraception during the study period and within 3 months after the last study administration;
- With my consent and signed informed consent form, I am willing and able to comply with planned visits, research treatments, laboratory inspections and other test procedures.
Who cannot join
- Subjects have clinically significant cardiovascular/cerebrovascular diseases, such as: cerebrovascular accident/stroke within 6 months before entering the study, myocardial infarction within 6 months before entering the study, unstable angina pectoris, NYHA level 2 or higher Patients with heart failure and clinically significant supraventricular or ventricular arrhythmia in need of treatment or intervention;
- The subject has any active autoimmune disease or a history of autoimmune disease (such as the following, but not limited to: interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, nephritis, vasculitis, decreased thyroid function [ Subjects who do not require medication or can be controlled by hormone replacement therapy only can be included]; subjects who have vitiligo or asthma has been completely relieved in childhood, and those who do not need any intervention after adults can be included; subjects who need bronchiectasis Asthma for medical intervention cannot be included);
- Known to be allergic to the study drug or any of its excipients, or have a severe allergic reaction to other monoclonal antibodies;
- He had other active malignant tumors within 2 years before entering the study. Except for skin basal cell or squamous cell carcinoma, superficial bladder cancer, cervical carcinoma in situ, intraductal carcinoma in situ of the breast, and papillary thyroid carcinoma that can be treated locally and have been cured;
- There is a large amount of fluid in the serous cavity that requires repeated puncture or drainage;
- There are major acute or chronic infections, including:
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- Active bacterial or fungal infections requiring systemic treatment;
- Active tuberculosis (tuberculosis, TB) or subjects with a history of active tuberculosis infection ≤48 weeks before screening, regardless of treatment;
- Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS);
- Untreated active hepatitis (hepatitis B, defined as HBV-DNA ≥ 2000 IU/ml or ≥ 104 copy/ml; hepatitis C, defined as HCV-RNA higher than the detection limit of the analysis method) or combined with hepatitis B and Co-infection of hepatitis C;
- During the screening period/before the first administration, fever of unknown origin> 38.5°C (according to the judgment of the investigator, fever caused by tumor can be included in the group);
- Participated in or are participating in other clinical studies within 4 weeks before starting the study drug treatment (subjects who have entered the follow-up period are calculated based on the time of the last use of the experimental drug or device);
- Has a history of psychotropic drug abuse or drug abuse. There are other serious physical or mental illnesses or laboratory abnormalities that may increase the risk of participating in the research, or interfere with the results of the research, as well as patients who the researcher believes are not suitable for participating in this research.
Trial locations and contacts
1 site in 1 country.
China1 site
Zhongshan Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality, 200433
About this study
The study is being conducted to evaluate the efficacy, and safety of SHR-1901 in subjects with advanced malignant tumors.To explore the reasonable dosage of SHR-1901.
- Conditions
- Advanced Malignant Tumors
- Being tested
- SHR-1901
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-1901Drug
SHR-1901 dose escalation at 0.1 mg/kg or 0.3 mg/kg or 1 mg/kg or 3 mg/kg or 10 mg/kg
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | SHR-1901 dose escalation at 0.1 mg/kg or 0.3 mg/kg or 1 mg/kg or 3 mg/kg or 10 mg/kg Receives: Drug: SHR-1901 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety endpoints: Number of subjects with adverse events and the severity of adverse events
Measured: every 4 weeks after treatment initiation（through study completion，average 5 months)
DLT
Measured: during the first 28-day cycle of SHR-1901 treatment
MTD
Measured: 4 weeks after treatment initiation
RP2D
Measured: 4 weeks after treatment initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2022
- Study start10 Feb 2022
- Primary completion2 Apr 2025
- Study completion2 Apr 2025
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.
- 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
- 25 participants (actual)
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
- NCT05193721
- Sponsor's protocol ID
- SHR-1901-I-101
- Status last verified
- Sep 2026
- First submitted
- 2 Dec 2021
- Last updated
- 23 Sep 2026
- 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 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study of the Safety and Tolerability of SHR-1901 in Subjects With Advanced Malignant Tumors
- ClinicalTrials.gov ID
- NCT05193721
- Acronym / sponsor ID
- SHR-1901-I-101
- Conditions
- Advanced Malignant Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 10 Feb 2022 (actual)
- Primary completion
- 2 Apr 2025 (actual)
- Study completion
- 2 Apr 2025 (actual)
- First posted
- 18 Jan 2022 (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.
The study is being conducted to evaluate the efficacy, and safety of SHR-1901 in subjects with advanced malignant tumors.To explore the reasonable dosage of SHR-1901.
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 | Experimental | Drug: SHR-1901SHR-1901 dose escalation at 0.1 mg/kg or 0.3 mg/kg or 1 mg/kg or 3 mg/kg or 10 mg/kg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients with advanced malignant tumors confirmed pathologically;
- Failure of adequate standard treatment, or no effective standard treatment;
- The expected survival period is more than 3 months;
- The Eastern Cooperative Oncology Group (ECOG) physical fitness score is 0 - 1;
- Have sufficient bone marrow and organ function (have not received blood transfusion or hematopoietic stimulating factor treatment within 14 days):(1)Neutrophil count (ANC) ≥ 1.5×10e9/L; (2)Platelet count (PLT) ≥90×10e9/L; (3)Hemoglobin (Hb) ≥ 9.0g/dL; (4)Serum creatinine ≤1.5 times the upper limit of normal (ULN) or creatinine clearance ≥60 ml/min (calculated using Cockcroft-Gault formula); (5)Total bilirubin (BIL) ≤1.5 times the upper limit of normal (ULN), patients with liver cancer/liver metastasis should be ≤2×ULN; (6)Aspartate aminotransferase (AST/SGOT) and alanine aminotransferase (ALT/SGPT) levels ≤ 3 times the upper limit of normal (ULN), patients with liver cancer/liver metastasis ≤ 5×ULN; (7)International normalized ratio (INR) ≤ 1.5, prothrombin time (PT) and activated partial thromboplastin time (APTT) ≤ 1.5 times ULN;
Key exclusion criteria (13 listed)
- Subjects have clinically significant cardiovascular/cerebrovascular diseases, such as: cerebrovascular accident/stroke within 6 months before entering the study, myocardial infarction within 6 months before entering the study, unstable angina pectoris, NYHA level 2 or higher Patients with heart failure and clinically significant supraventricular or ventricular arrhythmia in need of treatment or intervention;
- The subject has any active autoimmune disease or a history of autoimmune disease (such as the following, but not limited to: interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, nephritis, vasculitis, decreased thyroid function [ Subjects who do not require medication or can be controlled by hormone replacement therapy only can be included]; subjects who have vitiligo or asthma has been completely relieved in childhood, and those who do not need any intervention after adults can be included; subjects who need bronchiectasis Asthma for medical intervention cannot be included);
- Known to be allergic to the study drug or any of its excipients, or have a severe allergic reaction to other monoclonal antibodies;
- He had other active malignant tumors within 2 years before entering the study. Except for skin basal cell or squamous cell carcinoma, superficial bladder cancer, cervical carcinoma in situ, intraductal carcinoma in situ of the breast, and papillary thyroid carcinoma that can be treated locally and have been cured;
- There is a large amount of fluid in the serous cavity that requires repeated puncture or drainage;
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-1901SHR-1901 dose escalation at 0.1 mg/kg or 0.3 mg/kg or 1 mg/kg or 3 mg/kg or 10 mg/kg | Drug | Treatment group |
Primary outcome
Safety endpoints: Number of subjects with adverse events and the severity of adverse events
Time frame: every 4 weeks after treatment initiation（through study completion，average 5 months)
DLT
Time frame: during the first 28-day cycle of SHR-1901 treatment
MTD
Time frame: 4 weeks after treatment initiation
RP2D
Time frame: 4 weeks after treatment initiation
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 23 Sep 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site 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-1901 in people with Advanced Malignant Tumors, run by Suzhou Suncadia Biopharmaceuticals Co., Ltd. at 1 site in China.
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 7 inclusion and 13 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: finished, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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?
Safety endpoints: Number of subjects with adverse events and the severity of adverse events (time frame: every 4 weeks after treatment initiation（through study completion，average 5 months)). 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 23 Sep 2026; AzTrials last refreshed its copy on 8 Nov 2026.