Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT06245122

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Sun Yat-sen University Cancer Cancer

Guangzhou, China

Actively Recruiting

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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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A Study of CS23546 in Subjects With Advanced Tumors | DecenTrialz