NCT05836948 The Clinical Study of SHR-9839 for Injection in Patients With Advanced Solid Tumors
| NCT ID | NCT05836948 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Shanghai Hengrui Pharmaceutical Co., Ltd. |
| Condition | Advanced Solid Tumor |
| Study Type | INTERVENTIONAL |
| Enrollment | 174 participants |
| Start Date | 2023-05-18 |
| Primary Completion | 2026-05-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
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 174 participants in total. It began in 2023-05-18 with a primary completion date of 2026-05-01.
⚠ 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 study is an open-label, phase I clinical trial of SHR-9839 in patients with advanced solid tumors. The whole study is divided into three stages: dose escalation, dose expansion and efficacy expansion.
Eligibility Criteria
Inclusion Criteria: 1. Patients with histologically or cytologically confirmed unresectable locally advanced or metastatic solid tumors which is relapsed or refractory to standard treatment, or lack of standard treatment, or standard treatment is not applicable currently; 2. Have at least one measurable tumor lesion per RECIST v1.1; 3. ECOG performance status of 0-1; 4. Life expectancy ≥ 12 weeks; 5. Adequate bone marrow and organ function; 6. Subjects must voluntarily agree to participate in the trial and sign a written informed consent form. Exclusion Criteria: 1. Patients with active central nervous system metastases or meningeal metastases; 2. Received anti-tumor treatment such as chemotherapy, biotherapy, targeted therapy, immunotherapy, radical radiotherapy, or other unlisted clinical research drugs or treatments within 4 weeks prior to the first use of the study drug; 3. History of serious cardiovascular and cerebrovascular diseases; 4. Subjects who received\>30Gy of radiation therapy within 4 weeks before the first medication, and those who received ≤ 30Gy of palliative radiation therapy within 7 days before the first medication; 5. Adverse reactions of previous anti-tumor treatment have not recovered to Grade ≤ 1 per NCI-CTCAE v5.0.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05836948 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Advanced Solid Tumor. 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 NCT05836948 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 NCT05836948 currently recruiting?
Yes, NCT05836948 is actively recruiting participants. Contact the research team at rongfu.mao@hengrui.com for enrollment information.
Where is the NCT05836948 trial being conducted?
This trial is being conducted at Hangzhou, China.
Who is sponsoring the NCT05836948 clinical trial?
NCT05836948 is sponsored by Shanghai Hengrui Pharmaceutical Co., Ltd.. The trial plans to enroll 174 participants.