NCT07028281 A Trial of SHR-4849 Combined With Other Antitumor Drugs in Patients With Malignant Solid Tumors
| NCT ID | NCT07028281 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Suzhou Suncadia Biopharmaceuticals Co., Ltd. |
| Condition | Malignant Solid Tumors |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2025-07-08 |
| Primary Completion | 2028-12 |
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.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 120 participants in total. It began in 2025-07-08 with a primary completion date of 2028-12.
⚠ 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
The study is being conducted to evaluate the safety, tolerability and efficacy of SHR-4849 injection combined with other antitumor drugs in patients with malignant solid tumors.
Eligibility Criteria
Inclusion Criteria: 1. Subject has provided informed consent prior to initiation of any study-procedures 2. Age from 18 to 75 years old at the time of signing the informed consent 3. Histologically or cytologically confirmed solid tumors 4. At least one measurable lesion was identified per RECIST 1.1 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 6. Has a life expectancy of at least 3 months. 7. Adequate organ function 8. Subjects of both genders of child-bearing potential were required to use highly effective contraception from the time they provided written informed consent until 8 months after the last dose of the trial drug Exclusion Criteria: 1. Subjects with active central nervous system (CNS) metastasis. 2. Subjects with a history of malignant tumors within 5 years prior to the first dose 3. Subjects with uncontrolled cancer pain. 4. Subjects with severe cardiovascular disease. 5. Subjects with clinically significant hemorrhage 6. Subjects with uncontrolled pleural effusion, peritoneal effusion and pericardial effusion 7. Subjects highly suspected of interstitial lung disease 8. Subjects with serious infection within 4 weeks prior to the first dose 9. Known history of human immunodeficiency virus (HIV)，active hepatitis B virus or hepatitis C virus infection. 10. The adverse events of previous antineoplastic therapy did not recover to NCI-CTCAE≤ grade 1 11. Subjects who received anti-cancer treatment within 4 weeks prior to the first dose 12. Subjects who received major surgery within 4 weeks prior to the first dose 13. Subjects who plan to receive or have received live vaccines within 28 days prior to the first dose. 14. Female subjects who were pregnant, lactating, or planned to become pregnant during the study period 15. Known allergic to any component of investigational drugs 16. Alcohol abuse, drug abuse, other serious medical conditions (including mental illness) requiring combined treatment, and other conditions that may affect subject safety or data collection. 17. Based on the investigator's judgment, subjects with other conditions that may affect study results, interfere with study procedures,
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07028281 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Malignant 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 NCT07028281 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07028281 currently recruiting?
Yes, NCT07028281 is actively recruiting participants. Contact the research team at wei.hou@hengrui.com for enrollment information.
Where is the NCT07028281 trial being conducted?
This trial is being conducted at Jinan, China.
Who is sponsoring the NCT07028281 clinical trial?
NCT07028281 is sponsored by Suzhou Suncadia Biopharmaceuticals Co., Ltd.. The trial plans to enroll 120 participants.