Solid TumorPhase 1NCT07676903
A Clinical Study of SHR-4685 on Safety, Tolerability and Pharmacokinetics in Participants With Solid Tumors
A Phase 1 study testing SHR-4685 in people with Solid Tumor, run by Suzhou Suncadia Biopharmaceuticals Co., Ltd. at 6 sites in 2 countries.
Trial summary
The study is being conducted to evaluate the safety, tolerability and pharmacokinetics of SHR-4685 in participants with advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Solid Tumor
- What is being tested?
- SHR-4685
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 6 sitesin 2 countries
- Study dates
- 13 Aug 2026to Oct 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have fully understood this study and voluntarily signed the informed consent form, with good compliance and cooperation with follow-up;
- Age 18-75 years, any gender;
- Performance status ECOG score 0 or 1;
- Expected survival time greater than 3 months;
- Presence of at least one measurable lesion according to RECIST 1.1 criteria;
- Have adequate organ function;
- Female participants of childbearing potential must have a negative serum pregnancy test within 7 days prior to the first dose; and must not be lactating.
Who cannot join
- Participants who have received any approved anti-tumor drugs (including investigational anti-tumor drugs) within 4 weeks prior to the first dose of the IP;
- Toxicities from prior anti-tumor therapy have not recovered to ≤ Grade 1 or to the level specified in the inclusion/exclusion criteria;
- Presence of central nervous system (CNS) metastases;
- Concurrent active malignancy other than the primary tumor;
- History of central nervous system diseases within 12 months prior to screening;
- Participants who have undergone major surgery other than diagnostic or biopsy procedures within 28 days prior to the first dose, or who are expected to undergo major surgery during the study;
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- Participants with active tuberculosis or a history of active tuberculosis infection within ≤48 weeks prior to screening, regardless of treatment;
- Presence of any significant clinical or laboratory abnormality that, in the investigator's opinion, affects safety evaluation;
- History of deep vein thrombosis or pulmonary embolism within 6 months prior to screening;
- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring clinical intervention;
- Positive for human immunodeficiency virus (HIV) (HIV1/2 antibodies) with CD4+ T lymphocyte count <350 cells/uL; or history of other acquired/congenital immunodeficiency diseases; or history of allogeneic bone marrow or solid organ transplantation;
- Active chronic hepatitis B or active hepatitis C;
- Known history of hypersensitivity to any component of the formulations used in the study;
- Other factors, in the opinion of the investigator, that may affect the study results or result in forced halfway termination of this study, such as alcoholism, drug abuse, suffering from other serious diseases (including psychiatric disorders) requiring concomitant treatment, seriously abnormal laboratory test values, family or social factors and other conditions that may affect the safety of the patient or collection of study data.
Trial locations and contacts
6 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
6 sites in 2 countries
Australia5 sites, 5 recruiting
- Not yet recruiting
Cancer Research SA
Adelaide, South Australia, 5000
Chen Yong, Dr
- Not yet recruiting
Macquarie University Hospital
North Ryde, New South Wales, 2109
Andrew Parsonson, Dr
- Not yet recruiting
Epworth HealthCare - Richmond
Richmond, Victoria, 3121
Ross Jennens, Dr
- Not yet recruiting
Icon Cancer Centre South Brisbane
South Brisbane, Queensland, 4101
Jermaine Coward, A/Prof
- Not yet recruiting
GenesisCare North Shore
St Leonards, New South Wales, 2065
Nick Pavlakis, Dr
China1 site, 1 recruiting
- Recruiting
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142
Shaohua Ma, +86-13501090276, doctor_msh@bjmu.edu.cn
Shaohua Ma
About this study
Official title: A Phase I Clinical Study of SHR-4685 on Safety, Tolerability and Pharmacokinetics in Participants With Solid Tumors
The study is being conducted to evaluate the safety, tolerability and pharmacokinetics of SHR-4685 in participants with advanced solid tumors.
- Conditions
- Solid Tumor
- Being tested
- SHR-4685
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-4685Drug
SHR-4685, in different doses.
| Study group | Role | What they receive |
|---|---|---|
| SHR-4685 group | Experimental | Participants will receive SHR-4685 in different doses. Receives: Drug: SHR-4685 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting toxicity (DLT) of SHR-4685.
Measured: Up to 21 days.
Maximum tolerated dose (MTD) of SHR-4685.
Measured: Up to 24 months.
Recommended Phase II Dose (RP2D) of SHR-4685.
Measured: Up to 24 months.
Adverse events (AEs).
Measured: From the first drug administration to within 30 days for the last treatment dose, up to 24 months.
Serious adverse events (SAEs).
Measured: From the first drug administration to within 30 days for the last treatment dose, up to 24 months.
Secondary outcomes (8)
The concentration of SHR-4685 in plasma will be determined.
Cmax will be derived.
Measured: At predefined intervals throughout the treatment period, up to 24 months.
Time to maximum concentration (Tmax).
Evaluation of pharmacokinetic parameter of SHR-4685.
Measured: At predefined intervals throughout the treatment period, up to 24 months.
Area under the concentration-time curve from time 0 to time t (time of the last measurable concentration) (AUC0-t).
Evaluation of pharmacokinetic parameter of SHR-4685. The concentration of SHR-4685 in plasma will be determined. Area under the curve is the integral of the concentration-time curve. The AUC reflects the actual body exposure to drug after administration. The AUC is dependent on the rate of elimination of the drug from the body and the dose administered.
Measured: At predefined intervals throughout the treatment period, up to 24 months.
The concentration of Anti-SHR-4685 antibodies (ADA) in plasma will be determined.
Measured: At predefined intervals throughout the treatment period, up to 24 months.
Objective Response Rate (ORR).
Complete Response (CR) and Partial Response (PR) based on RECIST 1.1.
Measured: Up to 24 months.
Disease control rate (DCR).
Complete Response (CR), Partial Response (PR) and Stable Disease (SD) based on RECIST 1.1.
Measured: Up to 24 months.
Duration of response (DoR).
Time from documentation of tumor response to disease progression assessed among patients who had an objective response.
Measured: Up to 24 months.
Progression Free Survival (PFS).
Time from C1D1 to first assessment of disease progression or death, whichever is earlier.
Measured: Up to 24 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2026
- Study start13 Aug 2026
- Primary completionOct 2028 (estimated)
- Study completionOct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies 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
- Model description
- Single Group Assignment.
- Masking
- None (open label)
- Enrolment
- 170 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
- NCT07676903
- Sponsor's protocol ID
- SHR-4685-101
- Status last verified
- Jun 2026
- First submitted
- 24 Jun 2026
- Last updated
- 5 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Study of SHR-4685 on Safety, Tolerability and Pharmacokinetics in Participants With Solid Tumors
- ClinicalTrials.gov ID
- NCT07676903
- Acronym / sponsor ID
- SHR-4685-101
- Conditions
- Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 13 Aug 2026 (actual)
- Primary completion
- Oct 2028 (estimated)
- Study completion
- Oct 2028 (estimated)
- First posted
- 30 Jun 2026 (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 safety, tolerability and pharmacokinetics of SHR-4685 in participants with advanced solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single Group Assignment.
| Arm | Type | Receives |
|---|---|---|
| SHR-4685 group | Experimental | Drug: SHR-4685Participants will receive SHR-4685 in different doses. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Have fully understood this study and voluntarily signed the informed consent form, with good compliance and cooperation with follow-up;
- Age 18-75 years, any gender;
- Performance status ECOG score 0 or 1;
- Expected survival time greater than 3 months;
- Presence of at least one measurable lesion according to RECIST 1.1 criteria;
Key exclusion criteria (14 listed)
- Participants who have received any approved anti-tumor drugs (including investigational anti-tumor drugs) within 4 weeks prior to the first dose of the IP;
- Toxicities from prior anti-tumor therapy have not recovered to ≤ Grade 1 or to the level specified in the inclusion/exclusion criteria;
- Presence of central nervous system (CNS) metastases;
- Concurrent active malignancy other than the primary tumor;
- History of central nervous system diseases within 12 months prior to screening;
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-4685SHR-4685, in different doses. | Drug | SHR-4685 group |
Primary outcome
Dose-limiting toxicity (DLT) of SHR-4685.
Time frame: Up to 21 days.
Maximum tolerated dose (MTD) of SHR-4685.
Time frame: Up to 24 months.
Recommended Phase II Dose (RP2D) of SHR-4685.
Time frame: Up to 24 months.
Adverse events (AEs).
Time frame: From the first drug administration to within 30 days for the last treatment dose, up to 24 months.
Serious adverse events (SAEs).
Time frame: From the first drug administration to within 30 days for the last treatment dose, up to 24 months.
8 secondary outcomes
The concentration of SHR-4685 in plasma will be determined.
Time frame: At predefined intervals throughout the treatment period, up to 24 months.
Time to maximum concentration (Tmax).
Time frame: At predefined intervals throughout the treatment period, up to 24 months.
Area under the concentration-time curve from time 0 to time t (time of the last measurable concentration) (AUC0-t).
Time frame: At predefined intervals throughout the treatment period, up to 24 months.
The concentration of Anti-SHR-4685 antibodies (ADA) in plasma will be determined.
Time frame: At predefined intervals throughout the treatment period, up to 24 months.
Objective Response Rate (ORR).
Time frame: Up to 24 months.
Disease control rate (DCR).
Time frame: Up to 24 months.
Duration of response (DoR).
Time frame: Up to 24 months.
Progression Free Survival (PFS).
Time frame: Up to 24 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 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.
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SHR-4685 in people with Solid Tumor, run by Suzhou Suncadia Biopharmaceuticals Co., Ltd. at 6 sites in 2 countries.
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 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: looking for participants now, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Australia, 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ran Zhao, M.D (+86-0518-82342973, ran.zhao.rz7@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-limiting toxicity (DLT) of SHR-4685. (time frame: Up to 21 days.). The study lists 5 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 5 Oct 2026.