NCT07622225Not yet recruitingPhase 1
A Phase Ib/II Clinical Study to Evaluate the Safety and Efficacy of SYS6006 in Combination With Enlonstobart Injection Versus Enlonstobart Injection in Participants With Advanced Solid Tumors
CSPC Megalith Biopharmaceutical Co.,Ltd.0 sites264 target enrollmentStarted: May 29, 2026Last updated:
Trial Snapshot
- Phase
- Phase 1
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 264
Study Overview
Brief Summary
This study is a Phase Ib/II clinical study. It includes two stages: Phase Ib and Phase II. In the Phase Ib stage, the primary objective is to evaluate the safety and tolerability of SYS6006 in combination with Enlonstobart Injection in participants with advanced solid tumors, and to provide a basis for dose selection in later clinical studies. The primary objective of the Phase II stage is to assess efficacy and safety of SYS6006 in combination with Enlonstobart Injection in participants with advanced solid tumors.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •1. Able to understand and voluntarily sign the written informed consent form (ICF);
- •2. Male or female subjects aged over 18 years old (inclusive).
- •3. Patients with solid tumor who have unresectable locally advanced or metastatic disease;
- •4. At least one measurable lesion, as defined by RECIST 1.1 criteria;
- •5. ECOG performance status of 0-2;
- •6. Expected survival ≥ 3 months;
- •7. Adequate function of major organs and bone marrow;
- •8. Women or man of childbearing potential must use highly effective contraception.
Exclusion Criteria
- •1. Patients with metastases to meninges; with spinal cord compression; symptomatic and unstable brain metastasis;
- •2. Patients with a history of autoimmune diseases;
- •3. Presence of active infection (e.g., subjects are receiving anti-infection therapy);
- •4. Severe or uncontrolled cardiovascular disorder requiring treatment;
- •5. Women who are pregnant or breastfeeding.
Investigators
Similar Trials
Not yet recruiting
Phase 1
The Safety and Efficacy of Daratumumab in Patients With Refractory Aplastic AnemiaAplastic AnemiaNCT07287228Institute of Hematology & Blood Diseases Hospital, China37
Not yet recruiting
Phase 1
A Study of BL-M11D1 in Patients With Relapsed/Refractory Myelodysplastic SyndromesMyelodysplastic SyndromesNCT07591168Sichuan Baili Pharmaceutical Co., Ltd.92
Recruiting
Phase 1
A Phase Ib/II Trial of HS-20110 Combination Therapies in Advanced Colorectal Cancer Patients.CRCNCT07283367Hansoh BioMedical R&D Company502
Not yet recruiting
Phase 1
Safety and Efficacy of Paclitaxel Liposome Arterial Infusion Combined With Systemic Therapy for Second-Line Treatment of Advanced Liver CancerNCT07282509CSPC ZhongQi Pharmaceutical Technology Co., Ltd.116
Recruiting
Phase 1
A Phase I/III Clinical Study to Evaluate NouvNeu001 Injection for Multiple System AtrophyNCT07289477iRegene Therapeutics Co., Ltd.9