NCT06618651 A Study of SHR-3821 Injection in Subjects With Advanced Solid Tumors
| NCT ID | NCT06618651 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Suzhou Suncadia Biopharmaceuticals Co., Ltd. |
| Condition | Advanced Solid Tumors |
| Study Type | INTERVENTIONAL |
| Enrollment | 162 participants |
| Start Date | 2024-11-13 |
| Primary Completion | 2026-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 162 participants in total. It began in 2024-11-13 with a primary completion date of 2026-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is an open label, multi-center, multiple dose Phase I study to evaluate the safety, tolerability, pharmacokinetics and efficacy of SHR-3821 injection in subjects with 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06618651 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Advanced Solid Tumors. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06618651 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06618651 currently recruiting?
Yes, NCT06618651 is actively recruiting participants. Contact the research team at bin.bai@hengrui.com for enrollment information.
Where is the NCT06618651 trial being conducted?
This trial is being conducted at Chengdu, China.
Who is sponsoring the NCT06618651 clinical trial?
NCT06618651 is sponsored by Suzhou Suncadia Biopharmaceuticals Co., Ltd.. The trial plans to enroll 162 participants.