Evaluating SHR-3276 for patients with advanced malignant tumors

A Phase I/II Clinical Study on the Safety, Tolerability, Pharmacokinetics, and Efficacy of SHR-3276 Injection in Patients With Advanced Malignant Tumors

This study is testing a new treatment called SHR-3276 to see if it can help people with advanced solid tumors who have run out of other treatment options.

Quick facts

• Phase: PHASE1; PHASE2
• Study type: Interventional
• Enrollment: 115 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd. (industry)
• Locations: 1 site (Chongqing, Chongqing Municipality)
• Trial ID: NCT06643754 on ClinicalTrials.gov

What this trial studies

This open-label, multicenter Phase I/II clinical trial aims to assess the safety, tolerability, pharmacokinetics, and efficacy of SHR-3276 in patients suffering from advanced solid tumors. Participants will receive SHR-3276 injections and will be monitored for their response to the treatment. The study includes patients who have either failed standard treatments or have no effective treatment options available. The trial will also evaluate measurable lesions and the overall health status of participants.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-70 with pathologically confirmed advanced malignant tumors that have not responded to standard treatments.

Not a fit: Patients with central nervous system metastasis or uncontrolled tumor-related pain may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced malignant tumors who have limited alternatives.

How similar studies have performed: Other studies have shown promise with similar investigational treatments for advanced solid tumors, indicating potential for success.

Eligibility criteria

Inclusion Criteria:

1. Able and willing to sign a written informed consent；
2. Age 18-70 years old (including both ends), both male and female；
3. Pathologically confirmed advanced malignant tumors that have failed sufficient standard treatment or have no effective standard treatment plan；
4. Existence of measurable lesions；
5. ECOG score: 0-1；
6. Expected survival time ≥ 12 weeks；
7. The functional level of the major organs must meet the requirements；
8. Fertile female patients must have a serum pregnancy test within 7 days before the first medication and the result is negative; And must be non-lactating.

Exclusion Criteria:

1. Central nervous system metastasis or meningeal metastasis with clinical symptoms;
2. Spinal cord compression that has not been treated radically by surgery and/or radiotherapy；
3. Patients with uncontrolled tumor-related pain as judged by the investigator
4. A third space effusion with uncontrolled pleural effusion, pericardial effusion, or peritoneal effusion, as determined by the investigator；
5. Systemic antitumor therapy was administered within 28 days prior to treatment in the first study；
6. Surgical procedures requiring tracheal intubation and general anesthesia were performed within 28 days prior to the initial study, or elective surgery was expected during the trial period；
7. Serious drug-related adverse reactions during previous immune checkpoint inhibitor therapy；
8. Has unresolved toxicities from previous anticancer therapy, defined as toxicities not yet resolved to NCI-CTCAE version 5.0 grade ≤ 1；
9. Live attenuated vaccines were used within 28 days prior to administration in the first study or were expected to be required during the study treatment；
10. Systemic immunosuppressive therapy was administered within 14 days prior to the first study
11. Arterial/venous thrombosis events occurred within 3 months prior to initial administration
12. Patients with clinical significant lung disease;
13. Patients with history of autoimmune diseases;
14. The first study studied any other malignancy within 5 years prior to medication
15. A known history of severe allergic reactions to the investigational drug and its principal formulation ingredients；
16. Have a history of immune deficiency or organ transplantation；
17. Other serious accompanying illnesses, which, in the investigator's assessment, could seriously adversely affect the safety of the treatment.

Where this trial is running

Chongqing, Chongqing Municipality

• The Second Affiliated Hospital of PLA Army Medical University — Chongqing, Chongqing Municipality, China (RECRUITING)

Study contacts

• Study coordinator: Zhenqun Lu

Conditions: Advanced Solid Tumors