Evaluating CS23546 for patients with advanced tumors

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

This study is testing a new treatment called CS23546 to see if it's safe and how well it works for people with advanced tumors.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 156 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Chipscreen Biosciences, Ltd. (industry)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 1 site (Guangzhou)
• Trial ID: NCT06245122 on ClinicalTrials.gov

What this trial studies

This study aims to assess the safety and tolerability of CS23546 in patients with advanced tumors through a single-arm, open-label phase I trial. It includes a dose escalation phase, where both single and multiple doses will be administered, followed by a dose expansion phase. The study will also evaluate the pharmacokinetic characteristics of CS23546 and determine the recommended phase 2 dose. Participants will need to provide tumor tissue samples for further analysis of specific biomarkers.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with unresectable advanced recurrent or refractory solid tumors or lymphomas that have failed or are intolerant to all standard therapies.

Not a fit: Patients with resectable tumors or those who have not yet undergone standard therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for patients with advanced tumors who have exhausted standard therapies.

How similar studies have performed: Other studies evaluating similar investigational drugs in advanced tumors have shown promise, but the specific approach of CS23546 is novel.

Eligibility criteria

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.

Where this trial is running

Guangzhou

• Sun Yat-sen University Cancer Cancer — Guangzhou, China (RECRUITING)

Study contacts

• Principal investigator: Huiqiang Huang, Ph.D. — Sun Yat-sen University Cancer Cancer
• Study coordinator: Xinhao Wang

Conditions: Advanced Tumors