NCT06737731 A Phase I/II Clinical Study of SHR-1681 for Injection in Patients With Advanced Solid Tumors
| NCT ID | NCT06737731 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Suzhou Suncadia Biopharmaceuticals Co., Ltd. |
| Condition | Malignant Solid Tumors |
| Study Type | INTERVENTIONAL |
| Enrollment | 300 participants |
| Start Date | 2025-01-21 |
| Primary Completion | 2026-11 |
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 300 participants in total. It began in 2025-01-21 with a primary completion date of 2026-11.
⚠ 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, multicenter Phase I/II clinical trial to evaluate the safety, tolerability, pharmacokinetics and efficacy of SHR-1681 for injection in patients with advanced solid tumors.
Eligibility Criteria
Inclusion Criteria: 1. Subjects must voluntarily agree to participate in the trial and sign a written informed consent form; 2. Subjects 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; 3. Have at least one measurable tumor lesion per RECIST v1.1; 4. ECOG performance score of 0-1; 5. Life expectancy ≥ 3 months; 6. Adequate bone marrow and organ function. Exclusion Criteria: 1. Subjects with active central nervous system metastases or meningeal metastases; 2. History of serious cardiovascular and cerebrovascular diseases; 3. Subjects with a history of interstitial pneumonitis or imaging at screening suggestive of suspected interstitial pneumonitis; 4. Severe infection within 4 weeks prior to the first dose; 5. Ongoing or previous anti-tumor therapies within 4 weeks prior to the first dose of study drug; 6. 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 NCT06737731 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 NCT06737731 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 NCT06737731 currently recruiting?
Yes, NCT06737731 is actively recruiting participants. Contact the research team at fei.qiu@hengrui.com for enrollment information.
Where is the NCT06737731 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT06737731 clinical trial?
NCT06737731 is sponsored by Suzhou Suncadia Biopharmaceuticals Co., Ltd.. The trial plans to enroll 300 participants.