A Study of CS23546 in Subjects With Advanced Tumors

A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of CS23546 in Subjects With Advanced Tumors

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.

Study Overview

• Status: Recruiting
• Conditions: Advanced Tumors
• Intervention / Treatment: Drug: CS23546

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.

• Study Type: Interventional
• Enrollment (Estimated): 156
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Xinhao Wang; Phone Number: +86 0755-36993550; Email: xinhwang@chipscreen.com

Study Locations

• China
  • Guangzhou, China
    • Recruiting
    • Sun Yat-sen University Cancer Cancer
    • Contact: Su Li
    • Principal Investigator: Huiqiang Huang, Ph.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dose escalation; Single ascending dose (SAD): Participants will receive CS23546 once on the first day (D1). Multiple ascending dose (MAD): Participants will receive CS23546 once daily from the 7th day (C1D1).	Drug: CS23546; Tablets administered orally.
Experimental: Dose expansion; Dose expansion is planned to begin when the recommended Phase 2 dose (RP2D) will be determined.	Drug: CS23546; Tablets administered orally.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The inhibitory activity of Programmed cell death 1 ligand 1 (PD-L1)		up to Day 1 of cycle 5 (each cycle is 21 days)
Interferon gamma (IFN-γ)	Plasma concentration for IFN-γ.	up to Day 1 of cycle 5 (each cycle is 21 days)
Free PD-L1	Plasma concentration for free PD-L1.	up to Day 1 of cycle 5 (each cycle is 21 days)
C-X-C motif chemokine 9 (CXCL9)	Plasma concentration for CXCL9.	up to Day 1 of cycle 5 (each cycle is 21 days)
C-X-C motif chemokine 10 (CXCL10)	Plasma concentration for CXCL10.	up to Day 1 of cycle 5 (each cycle is 21 days)
Objective response rate (ORR)	Efficacy evaluation indicators for research.	Until 28 days after the last dose of the study drug
Disease control rate (DCR)	Efficacy evaluation indicators for research.	Until 28 days after the last dose of the study drug
Duration of response (DOR)	Efficacy evaluation indicators for research.	Until 28 days after the last dose of the study drug
Time to progression (TTP)	Efficacy evaluation indicators for research.	Until 28 days after the last dose of the study drug
time to progressive disease (TTR)	Efficacy evaluation indicators for research.	Until 28 days after the last dose of the study drug
Progression free survival (PFS)	Efficacy evaluation indicators for research.	Until 28 days after the last dose of the study drug
Overall survival (OS)	Efficacy evaluation indicators for research.	Until 28 days after the last dose of the study drug
Safety indicators: adverse events (AE)	The incidence and severity of adverse events (AE) (according to CTCAE v5.0).	Until 28 days after the last dose of the study drug

Collaborators and Investigators

• Sponsor: Chipscreen Biosciences, Ltd.
• Investigators: Principal Investigator: Huiqiang Huang, Ph.D., Sun Yat-sen University Cancer Cancer

Study record dates

Study Major Dates

• Study Start (Actual): March 27, 2024
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): May 31, 2027

Study Registration Dates

• First Submitted: December 26, 2023
• First Submitted That Met QC Criteria: February 5, 2024
• First Posted (Actual): February 7, 2024

Study Record Updates

• Last Update Posted (Actual): April 6, 2026
• Last Update Submitted That Met QC Criteria: April 3, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: CS23546-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No