Actively Recruiting
A Study of CS23546 in Subjects With Advanced Tumors
Led by Chipscreen Biosciences, Ltd. · Updated on 2026-04-06
156
Participants Needed
1
Research Sites
165 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The primary objectives of this study are to characterize the safety and tolerability of CS23546 and to evaluate the pharmacokinetic (PK) characteristics and recommended phase 2 dose (RP2D) of CS23546 in subjects with advanced tumors.
CONDITIONS
Official Title
A Study of CS23546 in Subjects With Advanced Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 years or older at informed consent
- Histologically or cytologically confirmed unresectable advanced recurrent/refractory solid tumor or lymphoma with no effective standard therapy
- Ability to provide tumor tissue samples for PD-L1 expression and/or MSI/MMR status testing; exceptions evaluated by researchers during dose escalation
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- Adequate organ function
- Life expectancy of at least 12 weeks
- For dose expansion phase: Subjects with urothelial carcinoma, extranodal NK/T-cell lymphoma, soft tissue sarcoma, or PD-L1 positive and/or MSI-H/dMMR advanced solid tumors or lymphoma
You will not qualify if you...
- Received anti-tumor therapy or experimental drugs/devices within 28 days before first dose
- History of Grade 3 or higher immune-related adverse events or treatment stopped due to such events from prior PD-1/PD-L1 antibody therapy
- Active autoimmune diseases treated systemically within 2 years before first dose (except those only requiring hormone replacement therapy)
- Presence of central nervous system or meningeal metastasis
- In dose expansion phase, prior PD-L1 inhibitor treatment with primary resistance
AI-Screening
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Trial Site Locations
Total: 1 location
1
Sun Yat-sen University Cancer Cancer
Guangzhou, China
Actively Recruiting
Research Team
X
Xinhao Wang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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