Advanced TumorsPhase 1NCT06245122
A Study of CS23546 in Subjects With Advanced Tumors
A Phase 1 study testing CS23546 in people with Advanced Tumors, run by Chipscreen Biosciences, Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Tumors
- What is being tested?
- CS23546
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- 1 siteChina
- Study dates
- 27 Mar 2024to 31 May 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Sun Yat-sen University Cancer Cancer
Guangzhou
Su Li
Huiqiang Huang, Ph.D.
About this study
Official title: 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.
Read the 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.
- Conditions
- Advanced Tumors
- Being tested
- CS23546
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CS23546Drug
Tablets administered orally.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Drug: CS23546 |
| Dose expansion | Experimental | Dose expansion is planned to begin when the recommended Phase 2 dose (RP2D) will be determined. Receives: Drug: CS23546 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Day 1 through Day 27
Time to Cmax (Tmax)
Time to reach the Cmax for CS23546.
Measured: up to Day 1 of cycle 5 (each cycle is 21 days)
Maximum plasma concentration (Cmax)
Maximum observed plasma concentration for CS23546.
Measured: 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.
Measured: 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)
Measured: up to Day 1 of cycle 5 (each cycle is 21 days)
Interferon gamma (IFN-γ)
Plasma concentration for IFN-γ.
Measured: up to Day 1 of cycle 5 (each cycle is 21 days)
Free PD-L1
Plasma concentration for free PD-L1.
Measured: up to Day 1 of cycle 5 (each cycle is 21 days)
C-X-C motif chemokine 9 (CXCL9)
Plasma concentration for CXCL9.
Measured: up to Day 1 of cycle 5 (each cycle is 21 days)
C-X-C motif chemokine 10 (CXCL10)
Plasma concentration for CXCL10.
Measured: up to Day 1 of cycle 5 (each cycle is 21 days)
Objective response rate (ORR)
Efficacy evaluation indicators for research.
Measured: Until 28 days after the last dose of the study drug
Disease control rate (DCR)
Efficacy evaluation indicators for research.
Measured: Until 28 days after the last dose of the study drug
Duration of response (DOR)
Efficacy evaluation indicators for research.
Measured: Until 28 days after the last dose of the study drug
Time to progression (TTP)
Efficacy evaluation indicators for research.
Measured: Until 28 days after the last dose of the study drug
time to progressive disease (TTR)
Efficacy evaluation indicators for research.
Measured: Until 28 days after the last dose of the study drug
Progression free survival (PFS)
Efficacy evaluation indicators for research.
Measured: Until 28 days after the last dose of the study drug
Overall survival (OS)
Efficacy evaluation indicators for research.
Measured: 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).
Measured: Until 28 days after the last dose of the study drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2024
- Study start27 Mar 2024
- Primary completion28 Feb 2027 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced TumorsStudies of the same condition, open and under way.
- More trials run by Chipscreen Biosciences, Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 156 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chipscreen Biosciences, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Huiqiang Huang, Ph.D., Principal investigator, Sun Yat-sen University Cancer Cancer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06245122
- Sponsor's protocol ID
- CS23546-101
- Status last verified
- Apr 2026
- First submitted
- 26 Dec 2023
- Last updated
- 6 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of CS23546 in Subjects With Advanced Tumors
- ClinicalTrials.gov ID
- NCT06245122
- Acronym / sponsor ID
- CS23546-101
- Conditions
- Advanced Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 156 participants (estimated)
- Lead sponsor
- Chipscreen Biosciences, Ltd.Industry (pharma, biotech, devices)
- Study start
- 27 Mar 2024 (actual)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 7 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dose escalation | Experimental | Drug: CS23546Single 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). |
| Dose expansion | Experimental | Drug: CS23546Dose expansion is planned to begin when the recommended Phase 2 dose (RP2D) will be determined. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CS23546Tablets administered orally. | Drug | Dose escalation, Dose expansion |
Primary outcome
Dose Limiting Toxicities (DLTs)
Time frame: Day 1 through Day 27
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.
Maximum Tolerated Dose (MTD)
Time frame: Day 1 through Day 27
MTD: One level lower than the dose level at which dose escalation was terminated due to DLT reasons.
Time to Cmax (Tmax)
Time frame: up to Day 1 of cycle 5 (each cycle is 21 days)
Time to reach the Cmax for CS23546.
Maximum plasma concentration (Cmax)
Time frame: up to Day 1 of cycle 5 (each cycle is 21 days)
Maximum observed plasma concentration for CS23546.
Area Under the Curve (AUC)
Time frame: up to Day 1 of cycle 5 (each cycle is 21 days)
Area Under the Plasma Concentration-time Curve From Zero Time to the Last Measurable Point for CS23546.
13 secondary outcomes
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
Safety indicators: adverse events (AE)
Time frame: Until 28 days after the last dose of the study drug
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Huiqiang Huang, Ph.D. principal investigator
Sun Yat-sen University Cancer Cancer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CS23546 in people with Advanced Tumors, run by Chipscreen Biosciences, Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xinhao Wang (+86 0755-36993550, xinhwang@chipscreen.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose Limiting Toxicities (DLTs) (time frame: Day 1 through Day 27). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2026.