A Study of SHR-4375 Injection in Combination With Other Antitumor Therapies in Patients With Solid Tumors
Recruiting
Phase 1Phase 2Interventional Study
Advanced Solid Tumor
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 75
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Treatment
Participants needed
198 (estimated)
Sponsor
Suzhou Suncadia Biopharmaceuticals Co., Ltd. · Industry
Who this trial is looking for
This trial is looking for adults aged 18-75 with advanced solid tumors that have not responded to standard treatments. Participants will receive the SHR-4375 injection alongside other cancer therapies and must consent to take part.
Are You a Good Fit for This Trial?
You may be able to join if
I am between 18 and 75 years old.
I have been diagnosed with an advanced solid tumor.
I have a life expectancy of at least 12 weeks.
I can provide a fresh or archived tumor tissue sample.
I have at least one measurable tumor lesion.
I have a good level of bone marrow and organ function.
I will use contraception during the trial.
You may not be able to join if
I have neuroendocrine carcinoma or sarcoma.
I received certain cancer treatments within the last 4 weeks.
I had major surgery in the last 28 days.
I have active hepatitis B or C.
I have uncontrolled tumor-related pain.
I have had severe infections in the last 30 days.
I have other active malignant tumors.
I have significant bleeding symptoms or tendencies.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
This is an open label, multi-center, Phase Ib/II study to evaluate the safety, tolerability and efficacy of SHR-4375 injection in combination with other antitumor therapies in patients with advanced solid tumors.
Trial Locations
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Status
Eligibility Criteria
Inclusion Criteria:
1. Voluntary participation and written informed consent.
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 …
Inclusion Criteria:
1. Voluntary participation and written informed consent.
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:
1. There are components of neuroendocrine carcinoma or sarcoma in the histopathological type.
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.
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