Recruiting NCT06245122
A Study of CS23546 in Subjects With Advanced Tumors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: CS23546.
- Who it may be relevant to
- Registry conditions: Advanced Tumors. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of CS23546 in Subjects With Advanced Tumors
Overview
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.
Detailed description
This study is a single arm, open phase I trial, consisting of a dose escalation phase (single dose+multiple doses) and a dose expansion phase, accompanied by pharmacokinetic and pharmacokinetic studies. The first visit period (21 days) of single dose and multiple doses during the dose-increasing phase is the DLT observation period.
Interventions
- Drug CS23546
Tablets administered orally.
Primary outcome measures
- Dose Limiting Toxicities (DLTs) [Time frame: Day 1 through Day 27]
- Maximum Tolerated Dose (MTD) [Time frame: Day 1 through Day 27]
- Time to Cmax (Tmax) [Time frame: up to Day 1 of cycle 5 (each cycle is 21 days)]
- Maximum plasma concentration (Cmax) [Time frame: up to Day 1 of cycle 5 (each cycle is 21 days)]
- Area Under the Curve (AUC) [Time frame: up to Day 1 of cycle 5 (each cycle is 21 days)]
Secondary outcome measures (12)
- The inhibitory activity of Programmed cell death 1 ligand 1 (PD-L1) [Time frame: up to Day 1 of cycle 5 (each cycle is 21 days)]
- Interferon gamma (IFN-γ) [Time frame: up to Day 1 of cycle 5 (each cycle is 21 days)]
- Free PD-L1 [Time frame: up to Day 1 of cycle 5 (each cycle is 21 days)]
- C-X-C motif chemokine 9 (CXCL9) [Time frame: up to Day 1 of cycle 5 (each cycle is 21 days)]
- C-X-C motif chemokine 10 (CXCL10) [Time frame: up to Day 1 of cycle 5 (each cycle is 21 days)]
- Objective response rate (ORR) [Time frame: Until 28 days after the last dose of the study drug]
- Disease control rate (DCR) [Time frame: Until 28 days after the last dose of the study drug]
- Duration of response (DOR) [Time frame: Until 28 days after the last dose of the study drug]
- Time to progression (TTP) [Time frame: Until 28 days after the last dose of the study drug]
- time to progressive disease (TTR) [Time frame: Until 28 days after the last dose of the study drug]
- Progression free survival (PFS) [Time frame: Until 28 days after the last dose of the study drug]
- Overall survival (OS) [Time frame: Until 28 days after the last dose of the study drug]
Eligibility criteria
Inclusion criteria
- Male or female and ≥18 years of age on day of signing informed consent.
- 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.
- 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.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
- Adequate organ function.
- Life expectancy ≥12 weeks.
- 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
Exclusion criteria
- 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.
- 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.
- 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.
- Presence of central nervous system metastasis and/or meningeal metastasis.
- Dose expansion phase: Subjects with solid tumors or lymphoma who have previously received PD-L1 inhibitors and belong to primary resistance.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Sun Yat-sen University Cancer Cancer — Guangzhou
Identifiers
NCT: NCT06245122 · CS23546-101