Evaluating SHR-3821 injection for advanced solid tumors

Phase I Study of Safety, Tolerability, Pharmacokinetics and Efficacy of SHR-3821 Injection in Subjects With Advanced Solid Tumors

This study is testing a new injection called SHR-3821 to see if it is safe and effective for people with advanced solid tumors.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 162 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd. (industry)
• Locations: 1 site (Chengdu, Sichuan)
• Trial ID: NCT06618651 on ClinicalTrials.gov

What this trial studies

This open-label, multi-center Phase I study aims to assess the safety, tolerability, pharmacokinetics, and efficacy of SHR-3821 injection in patients with advanced solid tumors. Participants will receive multiple doses of the treatment while their health and tumor response are closely monitored. The study will include individuals aged 18 to 75 with a pathologically diagnosed advanced solid tumor and at least one measurable lesion. The trial will also require participants to provide tumor tissue samples for analysis.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 with advanced solid tumors and a life expectancy of at least three months.

Not a fit: Patients with central nervous system metastasis or those who have received similar targeted therapies may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a new therapeutic option for patients with advanced solid tumors.

How similar studies have performed: While this approach is being explored in this specific context, similar studies have shown promise in evaluating new treatments for advanced solid tumors.

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 ≥ 3 months.
5. Pathologically diagnosed advanced solid tumor.
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 reserve and organ function.
9. Contraception is required during the trial.

Exclusion Criteria:

1. Meningeal metastasis history or clinical symptoms of central nervous system metastasis.
2. Uncontrollable tumor-related pain.
3. Uncontrolled pleural effusion, pericardial effusion, or abdominal effusion with clinical symptoms.
4. Received systemic antitumor therapy before the first dose.
5. Treated with similar target therapy as SHR-3821 before the first dose.
6. Received systemic anticancer treatments 4 weeks prior to the initiation of the study treatment.
7. Unresolved CTCAE 5.0\>=grade 2 toxicities from previous anticancer therapy.
8. Current or History of ILD.
9. Active severe digestive disease.
10. Previous or co-existing malignancies.
11. History of severe hypersensitivity reactions to either the drug substances or inactive ingredients of SHR-3821.
12. Active hepatitis B or active hepatitis C.
13. Other inappropriate situation considered by the investigator.

Where this trial is running

Chengdu, Sichuan

• West China Hospital of Sichuan Hospital — Chengdu, Sichuan, China (RECRUITING)

Study contacts

• Study coordinator: Bin bai

Conditions: Advanced Solid Tumors