NCT06703177 A Study of SHR-1826 for Injection in Combination With Other Antitumor Therapies in Subjects With Solid Tumors
| NCT ID | NCT06703177 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Suzhou Suncadia Biopharmaceuticals Co., Ltd. |
| Condition | Advanced Solid Tumors |
| Study Type | INTERVENTIONAL |
| Enrollment | 876 participants |
| Start Date | 2025-02-18 |
| 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 876 participants in total. It began in 2025-02-18 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 IB/II study to evaluate the safety, tolerability and efficacy of SHR-1826 for 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 clinical trials, and pregnancy tests must be negative for women of childbearing age within 7 days before the first dose. Exclusion Criteria: 1. Meningeal metastasis history or clinical symptoms of central nervous system metastasis; 2. Previous or co-existing malignancies; 3. Spinal cord compression that was not treated radically by surgery and/or radiotherapy was excluded; 4. Uncontrollable tumor-related pain; 5. Previously received antiboy-coupled drug therapy with topoisomerase I inhibitor toxin; Previously received EGFR/c-Met double antibody; 6. Received systemic antitumor therapy before the first dose; 7. Have undergone major surgery other than diagnosis or biopsy within 28 days prior to initial dosing; Minor traumatic surgery within 7 days prior to first dosing; 8. For the first time, a study was conducted to treat patients with radiation therapy exceeding the prescribed dose before study treatment; 9. Received Other investigational drugs treatments 4 weeks prior to the initiation of the study treatment; 10. Unresolved CTCAE 5.0\>grade 2 toxicities from previous anticancer therapy; 11. A history of interstitial pneumonia/non-infectious pneumonia; 12. Accompanied by uncontrolled pleural effusion and pericardial effusion; Moderate or severe ascites with clinical symptoms; 13. Study the presence of intestinal obstruction or the presence of signs or symptoms of intestinal obstruction 6 months before first dosing; 14. With poorly controlled or severe cardiovascular disease; 15. Active hepatitis B, hepatitis C; 16. Patients with a history of immunodeficiency; 17. Severe infection 30 days before the first dose.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06703177 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 NCT06703177 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 NCT06703177 currently recruiting?
Yes, NCT06703177 is actively recruiting participants. Contact the research team at rongfu.mao@hengrui.com for enrollment information.
Where is the NCT06703177 trial being conducted?
This trial is being conducted at Guangzhou, China.
Who is sponsoring the NCT06703177 clinical trial?
NCT06703177 is sponsored by Suzhou Suncadia Biopharmaceuticals Co., Ltd.. The trial plans to enroll 876 participants.