A Study of SHR-4375 Injection in Combination With Other Antitumor Therapies in Patients With Solid Tumors

Suzhou Suncadia Biopharmaceuticals

Status and phase: Not yet enrolling; Phase 2; Phase 1

Conditions: Advanced Solid Tumor

Treatments: Drug: Bevacizumab Injection; Drug: SHR-4375 Injection; Drug: Fluorouracil injection; Drug: Oxaliplatin injection; Drug: Paclitaxel for injection; Drug: Calcium Folinate Injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT07298772

SHR-4375-201

Details and patient eligibility

About

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.

Enrollment: 198 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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198 participants in 3 patient groups

Arm A

Experimental group

Treatment:

Drug: Paclitaxel for injection

Drug: SHR-4375 Injection

Arm B

Experimental group

Treatment:

Drug: Calcium Folinate Injection

Drug: Fluorouracil injection

Drug: SHR-4375 Injection

Drug: Bevacizumab Injection

Arm C

Experimental group

Treatment:

Drug: Calcium Folinate Injection

Drug: Oxaliplatin injection

Drug: Fluorouracil injection

Drug: SHR-4375 Injection

Drug: Bevacizumab Injection