A Study of CS23546 in Subjects With Advanced Tumors

NCT06245122 | Recruiting Phase 1

• 1 other identifier: CS23546-101
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Advanced Tumors

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (13)

• 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)

  up to Day 1 of cycle 5 (each cycle is 21 days)

• Free PD-L1

  up to Day 1 of cycle 5 (each cycle is 21 days)

• C-X-C motif chemokine 9 (CXCL9)

  up to Day 1 of cycle 5 (each cycle is 21 days)

• C-X-C motif chemokine 10 (CXCL10)

  up to Day 1 of cycle 5 (each cycle is 21 days)

Study Arms (2)

Dose escalation

EXPERIMENTAL

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

Dose expansion

EXPERIMENTAL

Dose expansion is planned to begin when the recommended Phase 2 dose (RP2D) will be determined.

Drug: CS23546

Interventions

CS23546 DRUG

Tablets administered orally.

Dose escalation; Dose expansion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chipscreen Biosciences, Ltd.: lead

Study Sites (1)

Sun Yat-sen University Cancer Cancer

Guangzhou, China

RECRUITING

Study Officials

• Huiqiang Huang, Ph.D.

  Sun Yat-sen University Cancer Cancer

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xinhao Wang

CONTACT

+86 0755-36993550; xinhwang@chipscreen.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 26, 2023
• First Posted: February 7, 2024
• Study Start: March 27, 2024
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): May 31, 2027
• Last Updated: April 23, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)