SHR-4375 combined with other cancer treatments for advanced solid tumors

A Phase Ib/II, Multicenter, Open-Label Study of Safety, Tolerability and Efficacy of SHR-4375 Injection in Combination With Other Antitumor Therapies in Patients With Advanced Solid Tumors

This study tests whether adding SHR-4375 to other cancer therapies helps adults with advanced solid tumors who have not responded to standard treatments.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 198 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd. (Industry-sponsored)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT07298772 on ClinicalTrials.gov

What this trial studies

This open-label, multicenter Phase Ib/II trial gives SHR-4375 injections together with other antitumor therapies to patients with advanced solid tumors to measure safety, tolerability, and preliminary anti-tumor activity. The Phase Ib portion uses dose-escalation to identify safe combination doses and the Phase II portion expands cohorts to look for signals of efficacy in specific tumor groups. Eligible participants must have measurable disease, adequate organ function, ECOG performance status 0–1, and be able to provide fresh or archived tumor tissue for testing. Patients will undergo regular clinical assessments and imaging to monitor side effects and tumor responses.

Who should consider this trial

Good fit: Adults aged 18–75 with advanced solid tumors who have progressed on or are intolerant to standard therapies, have ECOG 0–1, measurable disease, adequate organ function, and can provide tumor tissue are the intended participants.

Not a fit: Patients whose tumors contain neuroendocrine carcinoma or sarcoma components, those who received other anticancer treatments within four weeks, or those with poor performance status are unlikely to benefit from or qualify for this regimen.

Why it matters

Potential benefit: If successful, the combination could provide a new treatment option that controls tumor growth for some patients with advanced solid tumors.

How similar studies have performed: Some early-phase combination trials of investigational agents have shown activity in select solid tumors, but SHR-4375 combinations have limited published data and remain experimental.

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 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.

Where this trial is running

Shanghai, Shanghai Municipality

• Fudan University Shanghai Cancer Center — Shanghai, Shanghai Municipality, China (Recruiting)

Study contacts

• Study coordinator: Yunpeng Jing

Conditions Advanced Solid Tumor