Malignant Tumors of AdultsPhase 1NCT07068932
A Clinical Study of SHR-4506 Injection in Patients With Malignant Tumors
A Phase 1 study testing SHR-4506 Injection in people with Malignant Tumors of Adults, run by Suzhou Suncadia Biopharmaceuticals Co., Ltd. at 2 sites in China.
Trial summary
The study is being conducted to evaluate the safety and tolerability of SHR-4506 Injection in patients with malignant tumors and to determine the maximum tolerated dose (MTD) or maximum administered dose (MAD). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Tumors of Adults
- What is being tested?
- SHR-4506 Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 2 sitesChina
- Study dates
- 22 Jul 2025to Aug 2027
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years, any gender.
- ECOG performance status 0-1.
- Histologically or cytologically confirmed malignant tumor patients who have failed standard therapy, or are intolerant to standard therapy, or have no standard treatment available.
- Adequate organ function.
- Voluntary participation in this clinical trial, with full understanding of study procedures and ability to provide written informed consent.
- Expected survival ≥12 weeks.
- Patients in the dose-expansion phase must have measurable lesions.
- Agreement to use contraception from the time of signing the informed consent to at least 60 days after the last dose of the investigational drug.
Who cannot join
- Prior treatment with the same class of investigational drug.
- Confirmed or suspected central nervous system (CNS) tumor involvement.
- Uncontrolled tumor-related pain.
- Active autoimmune disease, history of immunodeficiency (including primary or secondary, e.g., HIV infection), or autoimmune disorders requiring systemic therapy.
- Clinically significant cardiovascular disease history.
- Known hypersensitivity to any component of the investigational drug.
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- Major surgery or significant trauma within 4 weeks prior to the first dose of the investigational drug; diagnostic or superficial surgery within 7 days before the first dose; or planned major surgery during the study period.
- Adverse events from prior therapy have not recovered to ≤ CTCAE Grade 1.
- Severe infection within 4 weeks before the first dose, or active infection within 2 weeks.
- History of cerebrovascular accident within 6 months before the first dose of the investigational drug.
- Patients with other active malignancies within 2 years prior to the first dose or concurrent malignancies.
- Patients with any other condition judged by the investigator that makes the patient unsuitable for participation in the study.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200025
Weilin Zhao, +86-021-64370045, zwl_trial@163.com
Weilin Zhao
- Recruiting
Renji Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200127
Xiuying Xiao, +86-021-68385559, Xiaoxiuying2002@163.com
Xiuying Xiao
About this study
Official title: Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of SHR-4506 Injection in Patients With Malignant Tumors
The study is being conducted to evaluate the safety and tolerability of SHR-4506 Injection in patients with malignant tumors and to determine the maximum tolerated dose (MTD) or maximum administered dose (MAD).
- Conditions
- Malignant Tumors of Adults
- Being tested
- SHR-4506 Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-4506 InjectionDrug
SHR-4506 injection.
| Study group | Role | What they receive |
|---|---|---|
| SHR-4506 Group | Experimental | Not described Receives: Drug: SHR-4506 Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose Limited Toxicities (DLTs)
Measured: Up to 21 days.
Maximum Tolerated Dose (MTD)
Measured: Up to 21 days.
Incidence and severity of adverse events (AEs)
Measured: Up to 90 days after the last dose.
Incidence and severity of serious adverse events (SAEs)
Measured: Up to 90 days after the last dose.
Secondary outcomes (5)
Objective response rate (ORR) assessed by the investigator
Measured: Up to 3 years.
Objective tumor response duration (DoR)
Measured: Up to 3 years.
Disease control rate (DCR)
Measured: Up to 3 years.
Progression free survival (PFS)
Measured: Up to 3 years.
Overall survival (OS)
Measured: Up to 3 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2025
- Study start22 Jul 2025
- Primary completionFeb 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Tumors of AdultsStudies 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
- 102 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
- NCT07068932
- Sponsor's protocol ID
- SHR-4506-101
- Status last verified
- May 2026
- First submitted
- 7 Jul 2025
- Last updated
- 18 May 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 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of SHR-4506 Injection in Patients With Malignant Tumors
- ClinicalTrials.gov ID
- NCT07068932
- Acronym / sponsor ID
- SHR-4506-101
- Conditions
- Malignant Tumors of Adults
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 22 Jul 2025 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 16 Jul 2025 (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 and tolerability of SHR-4506 Injection in patients with malignant tumors and to determine the maximum tolerated dose (MTD) or maximum administered dose (MAD).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SHR-4506 Group | Experimental | Drug: SHR-4506 Injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age ≥18 years, any gender.
- ECOG performance status 0-1.
- Histologically or cytologically confirmed malignant tumor patients who have failed standard therapy, or are intolerant to standard therapy, or have no standard treatment available.
- Adequate organ function.
- Voluntary participation in this clinical trial, with full understanding of study procedures and ability to provide written informed consent.
Key exclusion criteria (12 listed)
- Prior treatment with the same class of investigational drug.
- Confirmed or suspected central nervous system (CNS) tumor involvement.
- Uncontrolled tumor-related pain.
- Active autoimmune disease, history of immunodeficiency (including primary or secondary, e.g., HIV infection), or autoimmune disorders requiring systemic therapy.
- Clinically significant cardiovascular disease history.
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-4506 InjectionSHR-4506 injection. | Drug | SHR-4506 Group |
Primary outcome
Dose Limited Toxicities (DLTs)
Time frame: Up to 21 days.
Maximum Tolerated Dose (MTD)
Time frame: Up to 21 days.
Incidence and severity of adverse events (AEs)
Time frame: Up to 90 days after the last dose.
Incidence and severity of serious adverse events (SAEs)
Time frame: Up to 90 days after the last dose.
5 secondary outcomes
Objective response rate (ORR) assessed by the investigator
Time frame: Up to 3 years.
Objective tumor response duration (DoR)
Time frame: Up to 3 years.
Disease control rate (DCR)
Time frame: Up to 3 years.
Progression free survival (PFS)
Time frame: Up to 3 years.
Overall survival (OS)
Time frame: Up to 3 years.
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 18 May 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.
2 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-4506 Injection in people with Malignant Tumors of Adults, run by Suzhou Suncadia Biopharmaceuticals Co., Ltd. at 2 sites 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 8 inclusion and 12 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 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
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 Jie Shen (+86-0518-81220121, jie.shen@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose Limited Toxicities (DLTs) (time frame: Up to 21 days.). 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 18 May 2026.