NCT06245122 A Study of CS23546 in Subjects With Advanced Tumors
| NCT ID | NCT06245122 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Chipscreen Biosciences, Ltd. |
| Condition | Advanced Tumors |
| Study Type | INTERVENTIONAL |
| Enrollment | 156 participants |
| Start Date | 2024-03-27 |
| Primary Completion | 2027-02-28 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 156 participants in total. It began in 2024-03-27 with a primary completion date of 2027-02-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Huiqiang Huang, Ph.D.
PRINCIPAL INVESTIGATOR
Sun Yat-sen University Cancer Cancer
Frequently Asked Questions
Who can join the NCT06245122 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Advanced Tumors. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06245122 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06245122 currently recruiting?
Yes, NCT06245122 is actively recruiting participants. Contact the research team at xinhwang@chipscreen.com for enrollment information.
Where is the NCT06245122 trial being conducted?
This trial is being conducted at Guangzhou, China.
Who is sponsoring the NCT06245122 clinical trial?
NCT06245122 is sponsored by Chipscreen Biosciences, Ltd.. The principal investigator is Huiqiang Huang, Ph.D. at Sun Yat-sen University Cancer Cancer. The trial plans to enroll 156 participants.