Advanced MalignancyPhase 1NCT07123129
A Trial of SHR-7782 for Treatment of Advanced Malignant Tumors
A Phase 1 study testing SHR-7782 Injection in people with Advanced Malignancy, run by Suzhou Suncadia Biopharmaceuticals Co., Ltd. at 2 sites in China.
Trial summary
The main objective of this study is to evaluate the effectiveness and safety of SHR-7782 for participants with advanced malignant cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Malignancy
- What is being tested?
- SHR-7782 Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 2 sitesChina
- Study dates
- 28 Aug 2025to Dec 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participate in the study voluntarily, sign the informed consent form.
- Subjects were able to provide primary or metastatic cancer samples.
- At least one measurable lesion (RECIST version 1.1).
- ECOG 0~1.
- With adequate organ functions.
- Expected survival time ≥ 12 weeks.
Who cannot join
- With untreated brain metastasis or active central nervous system tumor metastases.
- Imaging shows that the tumor invades large blood vessels or has unclear boundaries with blood vessels.
- Patients with other malignant tumors in the past or at the same time.
- Patients with clinical symptoms, uncontrolled, or moderate or above pleural effusion, pericardial effusion, or peritoneal effusion.
- Patients with a history of interstitial pneumonia or interstitial lung disease or non-infectious pneumonia requiring steroid treatment.
- With poorly controlled or severe cardiovascular disease.
Show all 11Show fewer
- Bleeding events of NCI-CTCAE v5.0 grade ≥ 2 occurred within 1 month before the first medication.
- Subjects who had a serious infection within 1 month before the first medication.
- History of immunodeficiency.
- Known allergy to any component of the SHR-7782 product.
- According to the researcher's judgment, there are other factors that may affect the research results or cause the research to be terminated midway.
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
Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, Beijing Municipality, 100020
Ning Li, +86-010-87788713, lining@cicams.ac.cn
Ning Li
- Recruiting
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022
Tao Zhu, +86-0571-88128122, zhutao@zjcc.org.cn
Tao Zhu
About this study
Official title: An Open-label, Multicenter Phase I Clinical Study of SHR-7782 Injection in the Treatment of Advanced Malignant Cancer
The main objective of this study is to evaluate the effectiveness and safety of SHR-7782 for participants with advanced malignant cancer.
- Conditions
- Advanced Malignancy
- Being tested
- SHR-7782 Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-7782 InjectionDrug
SHR-7782 injection.
| Study group | Role | What they receive |
|---|---|---|
| SHR-7782 Group | Experimental | Not described Receives: Drug: SHR-7782 Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose Limited Toxicity (DLT)
Measured: Up to 21 days.
Maximum Tolerated Dose (MTD)
Measured: Up to 6 months.
Recommended Phase II Dose (RP2D)
Measured: Up to 21 days.
Secondary outcomes (5)
Objective Response Rate (ORR) assessed by the investigator according to RECIST 1.1 criteria
Measured: Up to approximately 24 months.
Duration of Response (DoR) assessed by the investigator according to RECIST 1.1 criteria
Measured: Up to approximately 24 months.
Disease Control Rate (DCR) assessed by the investigator according to RECIST 1.1 criteria
Measured: Up to approximately 24 months.
Progression Free Survival (PFS) assessed by the investigator according to RECIST 1.1 criteria
Measured: Up to approximately 24 months.
Overall Survival (OS)
Measured: Up to approximately 24 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2025
- Study start28 Aug 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced MalignancyStudies 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
- 200 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
- NCT07123129
- Sponsor's protocol ID
- SHR-7782-101
- Status last verified
- Jan 2026
- First submitted
- 7 Aug 2025
- Last updated
- 30 Jan 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 30 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Multicenter Phase I Clinical Study of SHR-7782 Injection in the Treatment of Advanced Malignant Cancer
- ClinicalTrials.gov ID
- NCT07123129
- Acronym / sponsor ID
- SHR-7782-101
- Conditions
- Advanced Malignancy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 28 Aug 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 14 Aug 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 main objective of this study is to evaluate the effectiveness and safety of SHR-7782 for participants with advanced malignant cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SHR-7782 Group | Experimental | Drug: SHR-7782 Injection |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Participate in the study voluntarily, sign the informed consent form.
- Subjects were able to provide primary or metastatic cancer samples.
- At least one measurable lesion (RECIST version 1.1).
- ECOG 0~1.
- With adequate organ functions.
Key exclusion criteria (11 listed)
- With untreated brain metastasis or active central nervous system tumor metastases.
- Imaging shows that the tumor invades large blood vessels or has unclear boundaries with blood vessels.
- Patients with other malignant tumors in the past or at the same time.
- Patients with clinical symptoms, uncontrolled, or moderate or above pleural effusion, pericardial effusion, or peritoneal effusion.
- Patients with a history of interstitial pneumonia or interstitial lung disease or non-infectious pneumonia requiring steroid treatment.
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-7782 InjectionSHR-7782 injection. | Drug | SHR-7782 Group |
Primary outcome
Dose Limited Toxicity (DLT)
Time frame: Up to 21 days.
Maximum Tolerated Dose (MTD)
Time frame: Up to 6 months.
Recommended Phase II Dose (RP2D)
Time frame: Up to 21 days.
5 secondary outcomes
Objective Response Rate (ORR) assessed by the investigator according to RECIST 1.1 criteria
Time frame: Up to approximately 24 months.
Duration of Response (DoR) assessed by the investigator according to RECIST 1.1 criteria
Time frame: Up to approximately 24 months.
Disease Control Rate (DCR) assessed by the investigator according to RECIST 1.1 criteria
Time frame: Up to approximately 24 months.
Progression Free Survival (PFS) assessed by the investigator according to RECIST 1.1 criteria
Time frame: Up to approximately 24 months.
Overall Survival (OS)
Time frame: Up to approximately 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 30 Jan 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Advanced Malignancy
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 3
A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
Carcinoma, Renal Cell
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
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-7782 Injection in people with Advanced Malignancy, 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 6 inclusion and 11 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 30 Jan 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 Zhifei Lin (+86-0518-82342973, zhifei.lin.zl3@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: Up to 21 days.). The study lists 3 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 30 Jan 2026.