A Study of SHR-4375 Injection in Combination With Other Antitumor Therapies in Patients With Solid Tumors
NCT ID: NCT07298772
Last Updated: 2025-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE1/PHASE2
198 participants
INTERVENTIONAL
2025-12-31
2028-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Arm A
SHR-4375 Injection
SHR-4375 injection.
Paclitaxel for injection
Paclitaxel for injection.
Arm B
SHR-4375 Injection
SHR-4375 injection.
Bevacizumab Injection
Bevacizumab injection.
Fluorouracil injection
Fluorouracil injection.
Calcium Folinate Injection
Calcium Folinate injection.
Arm C
SHR-4375 Injection
SHR-4375 injection.
Bevacizumab Injection
Bevacizumab injection.
Fluorouracil injection
Fluorouracil injection.
Calcium Folinate Injection
Calcium Folinate injection.
Oxaliplatin injection
Oxaliplatin injection.
Interventions
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SHR-4375 Injection
SHR-4375 injection.
Bevacizumab Injection
Bevacizumab injection.
Fluorouracil injection
Fluorouracil injection.
Calcium Folinate Injection
Calcium Folinate injection.
Paclitaxel for injection
Paclitaxel for injection.
Oxaliplatin injection
Oxaliplatin injection.
Eligibility Criteria
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Inclusion Criteria
2. 18-75 years older, no gender limitation.
3. Eastern Cooperative Oncology Group (ECOG) score: 0-1.
4. With a life expectancy ≥ 12 weeks.
5. Patients with advanced solid tumors confirmed by cytology or histology who have failed or are intolerant to standard treatment and have no standard treatment.
6. Be able to provide fresh or archived tumour tissue.
7. At least one measurable lesion according to RECIST v1.1.
8. Adequate bone marrow and organ function.
9. Contraception is required during clinical trials, and pregnancy tests must be negative for women of childbearing age within 7 days before the first dose.
Exclusion Criteria
2. Had received chemotherapy, immunotherapy, targeted therapy, anti-tumor traditional Chinese medicine or other clinical research drugs within 4 weeks prior to the first administration of the study; Palliative radiotherapy was received within 2 weeks before the first administration.
3. Live attenuated vaccines are used within a certain period of time before the first medication as stipulated in the plan, or it is expected that such vaccines will be needed during the treatment period.
4. Having undergone major surgeries other than diagnosis or biopsy within 28 days prior to the first administration.
5. Previously received antibody-drug conjugate therapy containing topoisomerase I inhibitors.
6. Currently participating in other clinical studies or taking medication for the first time less than 4 weeks after the end of the previous clinical study.
7. Suffering from other active malignant tumors within 3 years or at the same time.
8. Symptomatic or active central nervous system tumor metastasis.
9. Accompanied by uncontrolled tumor related pain.
10. Subjects who have experienced severe infections within 30 days prior to their first medication use.
11. History of interstitial pneumonia/non infectious pneumonia requiring hormone therapy in the past.
12. AE caused by previous anti-tumor treatment has not recovered to CTCAE v5.0 level evaluation ≤ 1.
13. Active hepatitis B or active hepatitis C.
14. Clinically significant bleeding symptoms or significant bleeding tendency occurred within 1 month before the first medication.
15. Moderate and severe ascites with clinical symptoms; Uncontrolled or moderate to excessive pleural effusion and pericardial effusion.
16. Uncontrollable mental illness and other conditions known to affect the completion of the study process, such as alcohol, drug or substance abuse, and criminal detention.
17. Per the investigator's judgment, there are any other circumstances that may increase the risk of participating in the study, interfere with the study results, or make participation in the study inappropriate.
18 Years
75 Years
ALL
No
Sponsors
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Suzhou Suncadia Biopharmaceuticals Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Xianjun Yu
Role: primary
Other Identifiers
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SHR-4375-201
Identifier Type: -
Identifier Source: org_study_id