Phase I/II Clinical Trials of SHR-8203 Injection in Participants With Advanced Solid Tumors
- Sponsor
- Beijing Suncadia Pharmaceuticals Co., Ltd
- Study ID
- NCT07769242
- Phase
- PHASE1/PHASE2
- Status
- Not Yet Recruiting
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Conditions
- Solid Tumors
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 75 Years
- Healthy Volunteers
- Not accepted
Interventions
- SHR-8203 Injection — DRUGSHR-8203 Injection Dose 1/ Dose 2/ Dose 3/ Dose 4
Study Details
This trial is a multicenter, open-label Phase I/II clinical study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, and efficacy of SHR-8203 injection in participants with advanced solid tumors.
Key Dates
- First listed
- Aug 17, 2026
- Start date
- Sep 1, 2026
- Status verified
- Aug 2026
- Primary completion
- Dec 30, 2029
- Completion
- Dec 30, 2029
Study Design
- Enrollment
- 200 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: SHR-8203 Injection
Primary Outcome Measure
The number of subjects with dose-limiting toxicity (DLT) [ Time Frame: From first dose of study treatment until the end of Cycle 1(up to 21 days) ]
Central Contacts
- Fang fang Peng, Doctoral degree17721288185
- Xin Xu, Bachelor's degree18036618833
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