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Recruiting Phase 1

A Study of CS23546 in Subjects With Advanced Tumors

NCT06245122 · tracked via the Priya Life Science China tracker
Phase
Phase 1
Started
2024-03-27
Last updated
2026-04-06

Condition(s) studied

Advanced Tumors

Investigational drug(s) / intervention(s)

CS23546

CS23546: Tablets administered orally.

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Key Inclusion Criteria: 1. Male or female and ≥18 years of age on day of signing informed consent. 2. Histologically or cytologically confirmed unresectable advanced recurrent/refractory solid tumor or lymphoma that is failure or or intolerant of all standard therapy or for which no standard therapy is available. 3. Individuals are required to provide tumor tissue samples for prospective detection of Programmed cell death 1 ligand 1 (PD-L1) expression and/or Microsatellite instability (MSI) / the DNA mismatch repair (MMR) status. Subjects who cannot be provided during the dose escalation phase will be evaluated by the researchers and sponsors before deciding whether to enroll. 4. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1. 5. Adequate organ function. 6. Life expectancy ≥12 weeks. 7. Dose expansion phase: Cohort 1, Subjects with urothelial carcinoma. Cohort 2, Subjects with Extranodal NK/T-cell lymphoma (NKTCL). Cohort 3, Subjects with soft tissue sarcoma. Cohort 4, Subjects with PD-L1 expression positive and/or microsatellite-instability-high (MSI-H) / mismatch-repair-deficient (dMMR) advanced solid tumors or lymphoma Key Exclusion Criteria: 1. Received anti-tumor therapy (including but not limited to chemotherapy, targeted therapy, anti angiogenic therapy, immunotherapy, cell therapy, radiotherapy, tumor embolization, etc.) or experimental drugs/devices that have not been approved for marketing within 28 days before the first medication. 2. History of ≥ Grade 3 immune related Adverse Events (irAEs) or termination of treatment due to irAEs during prior treatment with Programmed death 1 (PD-1) /PD-L1 antibody. 3. Active autoimmune diseases present during the screening period and systemic treatment was received within 2 years before the first medication. Individuals who only require hormone replacement therapy (such as thyroxine, insulin, or physiological corticosteroids used for adrenal or pituitary insufficiency) can be enrolled. 4. Presence of central nervous system metastasis and/or meningeal metastasis. 5. Dose expansion phase: Subjects with solid tumors or lymphoma who have previously received PD-L1 inhibitors and belong to primary resistance.

Primary outcome measure(s)

  • Dose Limiting Toxicities (DLTs) — Day 1 through Day 27
    DLT: Number of patients experienced any dose limited toxicity. MTD: One level lower than the dose level at which dose escalation was terminated due to DLT reasons.
  • Maximum Tolerated Dose (MTD) — Day 1 through Day 27
    MTD: One level lower than the dose level at which dose escalation was terminated due to DLT reasons.
  • Time to Cmax (Tmax) — up to Day 1 of cycle 5 (each cycle is 21 days)
    Time to reach the Cmax for CS23546.
  • Maximum plasma concentration (Cmax) — up to Day 1 of cycle 5 (each cycle is 21 days)
    Maximum observed plasma concentration for CS23546.
  • Area Under the Curve (AUC) — up to Day 1 of cycle 5 (each cycle is 21 days)
    Area Under the Plasma Concentration-time Curve From Zero Time to the Last Measurable Point for CS23546.

Trial sites (1)

FacilityCityRegionStatus
Sun Yat-sen University Cancer Cancer Guangzhou China Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06245122 on ClinicalTrials.gov ↗ ← All trials in China