NeoplasmsPhase 1NCT06902350
Safety, Pharmacokinetics and Preliminary Efficacy of CS231295 in Advanced Solid Tumors
A Phase 1 study testing CS231295 in people with Neoplasms and Glioblastoma, Adult, run by Chipscreen Biosciences, Ltd. at 2 sites in China.
Trial summary
This trial is a single-arm, open-label, first-in-human study of CS231295, comprising two phases: dose escalation (including single-dose and multiple-dose) and cohort expansion. The Dose-Limiting Toxicity (DLT) observation period includes 6 days for single-dose and the first cycle (28 days) for multiple-dose. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasms, Glioblastoma, Adult, Small Cell Lung Carcinoma (SCLC)
- What is being tested?
- CS231295
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 2 sitesChina
- Study dates
- 21 May 2025to Apr 2029
- 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
- Understand and sign the informed consent form voluntarily.
- ≥18 years old when signing the informed consent, regardless of sex.
- Have histologically or cytologically confirmed unresectable advanced, recurrent, or metastatic solid tumors (including but not limited to small cell lung cancer, glioblastoma, urothelial carcinoma, endometrial cancer, cervical cancer, ovarian cancer, breast cancer, and liver cancer) for which standard therapy has failed or was intolerable, and currently no standard treatment is available.
- Radiological or histopathological evidence indicating disease progression should be documented.
- Intolerance is defined as discontinuation of treatment due to adverse events during therapy.
- Recurrence is based on radiological or histopathological results.
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- For glioblastoma: at least one measurable intracranial tumor lesion according to the RANO 2.0 criteria. For other solid tumors: at least one measurable lesion according to RECIST v1.1 criteria. Note: Target lesions can be located in previously irradiated areas, but must be confirmed by imaging to show disease progression after radiation.
- For glioblastoma: KPS score ≥60. For other solid tumors: ECOG performance status of 0 or 1.
- Meet the following laboratory criteria (without receiving any blood products, hematopoietic growth factors, albumin, or other treatments within 14 days prior to testing, except iron supplements):
- Hematology: Hemoglobin (Hb) ≥100 g/L, absolute neutrophil count (ANC) ≥1.5×10^9/L, platelet (PLT) count ≥100×10^9/L.
- Biochemistry: 1) Dose escalation phase: Serum creatinine (Cr) ≤ upper limit of normal (ULN); total bilirubin (TBIL) ≤1.25×ULN; alanine aminotransferase (ALT), aspartate aminotransferase (AST) ≤1.5×ULN (for subjects with liver metastases or hepatocellular carcinoma: ≤3×ULN). 2) Cohort expansion phase: Cr ≤1.5×ULN; TBIL ≤1.5×ULN; ALT, AST ≤2.5×ULN (for subjects with liver metastases or hepatocellular carcinoma: ≤5×ULN).
- Coagulation: International normalized ratio (INR) ≤1.5×ULN; prothrombin time (PT) and activated partial thromboplastin time (APTT) ≤1.5×ULN (for participants receiving prophylactic anticoagulation, the INR and APTT should be within a safe and effective therapeutic range as judged by the investigator).
- Urinalysis: Urine protein <2+; if ≥2+, a 24-hour urine protein quantification should be performed. <1 g/24 h can be enrolled but ≥1 g/24 h is prohibited. without quantification when urine protein ≥2+ is not allowed.
- Expected survival ≥12 weeks.
- Cohort Expansion Phase: 1) Cohort 1: Histologically or cytologically confirmed small cell lung cancer (SCLC) that has progressed or recurred after at least two lines of systemic chemotherapy (including a platinum-based regimen). Note: A new line of treatment is defined as a change in treatment due to disease progression, not due to toxicity or other reasons. Re-initiation of the same treatment regimen after initial progression is considered a new line of treatment. 2) Cohort 2: Recurrent or progressive glioblastoma confirmed by histopathology or imaging, which has progressed or recurred after at least one prior treatment with temozolomide.
Who cannot join
- Received any form of intracranial radiotherapy within 3 months prior to the first dose.
- Received any anti-tumor treatment (including but not limited to chemotherapy, targeted therapy, immunotherapy, cellular therapy, radiation therapy [see exclusion criterion #1 for head], endocrine anti-tumor therapy, tumor embolization) or unapproved investigational drugs or devices within 28 days prior to the first dose. Also, received Traditional Chinese Medicine (TCM) approved by the National Medical Products Administration (NMPA) for treating malignant tumors within 14 days prior to the first dose.
- Previously received Aurora kinase inhibitors.
- Used strong inducers or inhibitors of cytochrome P450 3A (CYP3A) enzymes within 14 days prior to the first dose or are still within 7 half-lives of such drugs (whichever is longer).
- For glioblastoma only: >5 mg/day dexamethasone or equivalent doses of other glucocorticoids for systemic treatment related to glioblastoma within 1 week prior to the first dose.
- Underwent major surgery (cranial, thoracic, or abdominal) within 28 days prior to the first dose or have unresolved wounds, ulcers, or fractures as judged by the investigator at screening.
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- Have unresolved toxicities from previous treatments that have not recovered to CTCAE v5.0 grade ≤1, except for alopecia or laboratory abnormalities deemed no clinical significant by the investigator.
- History of other primary malignancies within 5 years prior to the first dose, except for adequately treated in situ carcinoma, non-melanoma skin cancer, or malignant melanosis.
- For solid tumors other than glioblastoma: Unstable brain metastases. Stable brain metastases are allowed if:
- No immediate or planned local treatment for brain metastases during the study.
- No neurological symptoms or signs (e.g., increased intracranial pressure, seizures, cognitive impairment) at screening.
- Brain lesions stable for ≥2 weeks prior to the first dose without corticosteroid or anticonvulsant treatment.
- Leptomeningeal metastasis (except glioblastoma).
- Severe brain herniation or risk thereof.
- For glioblastoma only: who had wafer(s) implantation during surgery.
- Received drainage of pleural effusion, ascites, or pericardial effusion within 1 month prior to the first dose or have significant clinical symptoms (e.g., chest tightness, shortness of breath, dyspnea).
- Uncontrolled or significant cardiovascular disease, including:
- NYHA Class II or higher congestive heart failure, unstable angina, myocardial infarction within 6 months prior to the first dose, or arrhythmias requiring treatment, left ventricular ejection fraction (LVEF) <50% at screening.
- Primary cardiomyopathy (e.g., dilated, hypertrophic, arrhythmogenic right ventricular, restrictive, or unclassified cardiomyopathy).
- Symptomatic coronary artery disease requiring medication at screening.
- Clinically significant QTcF prolongation history or QTcF >470 ms (females) and >450 ms (males) at screening.
- Significant cerebrovascular accident (including cerebral hemorrhage, transient ischemic attack) within 6 months prior to the first dose.
- Use of ≥3 antihypertensive drug components within 14 days prior to the first dose or inadequately controlled blood pressure (systolic BP ≥140 mmHg or diastolic BP ≥90 mmHg) at screening.
- Other cardiovascular conditions deemed unsuitable by the investigator.
- Poorly controlled diabetes (fasting glucose >10 mmol/L).
- Significant gastrointestinal abnormalities at screening that may affect drug intake, transport, or absorption (e.g., inability to swallow, chronic diarrhea, bowel obstruction, small bowel resection, or total gastrectomy).
- Clinically significant hemoptysis or tumor bleeding within 14 days prior to the first dose; significant active bleeding within 2 months prior to the first dose (e.g., gastrointestinal bleeding); currently on anticoagulants (e.g., warfarin, phenprocoumon, but low-dose aspirin and heparin for prophylaxis allowed); high-risk bleeding tendency at screening (e.g., esophageal varices, active ulcerative lesions, positive occult blood in stool, imaging evidence of tumor invasion into large vessels).
- Serious thromboembolic events within 6 months prior to the first dose (e.g., arterial thrombosis, pulmonary embolism, deep vein thrombosis). Implanted venous port or catheter-related thrombi, superficial vein thrombi, or those deemed stable and not requiring emergency medical intervention are not considered "serious."
- Active infection requiring intravenous treatment at screening. Severe infections (e.g., hospitalization due to infection, bacteremia, severe pneumonia complications) within 28 days prior to the first dose. Patients receiving prophylactic antibiotics (e.g., for urinary tract infections or COPD exacerbations) can be enrolled.
- Known active tuberculosis, currently receiving anti-tuberculosis treatment, or received anti-tuberculosis treatment within 1 year prior to the first dose.
- Active hepatitis B (HBsAg or HBcAb positive with viral replication) or hepatitis C (HCV antibody positive with viral replication) at screening.
- Human immunodeficiency virus (HIV) infection or syphilis infection (positive specific antibody test followed by positive non-specific antibody test) at screening.
- Allergy or hypersensitivity to any component of the trial drug or known excipients, or history of severe allergic diseases.
- History of organ transplantation or allogeneic hematopoietic stem cell transplantation.
- History of alcohol abuse or drug abuse.
- Any psychiatric or cognitive disorder that may limit understanding of informed consent, compliance with the protocol, or participation in the trial.
- Unwilling or unable to use effective contraception methods during the entire treatment period and up to 3 months after the last dose for women of childbearing potential (defined as having experienced menarche and not undergone successful artificial sterilization [hysterectomy, bilateral tubal ligation, or bilateral oophorectomy] or not postmenopausal) or male patients whose partners are women of childbearing potential; pregnant or breastfeeding women.
- Other conditions deemed unsuitable for participation in this trial by the investigator.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Not yet recruiting
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, 100070
Wenbin Li, M.D., +86 010-59978585, neure55@126.com
- Recruiting
Jilin Cancer Hospital
Changchun, Jilin, 130103
Ying Cheng, +86 0431-80596003, jl.cheng@163.com
About this study
Official title: A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of CS231295 in Subjects With Advanced Solid Tumors
This trial is a single-arm, open-label, first-in-human study of CS231295, comprising two phases: dose escalation (including single-dose and multiple-dose) and cohort expansion. The Dose-Limiting Toxicity (DLT) observation period includes 6 days for single-dose and the first cycle (28 days) for multiple-dose. The overall study consists of screening period, treatment period, and follow-up period.
The primary objectives of this study are to evaluate the safety, tolerability and pharmacokinetic (PK) characteristics of CS231295 in patients with advanced solid tumors, and to recommended Phase 2 dose(s) (RP2D) of CS231295 in appropriate tumor(s).
- Being tested
- CS231295
- Medical subject headings
- Neoplasms, Glioblastoma, Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CS231295Drug
oral tablet. Only one dose on C0D1 in single-dose period. Once daily from C1D1 until disease progression, death, intolerable toxicity, loss to follow-up, withdrawal of informed consent, or the end of the trial, whichever occurs first, in multiple-dose period in both escalation and cohort expansion phases.
| Study group | Role | What they receive |
|---|---|---|
| CS231295 | Experimental | two phases: dose escalation and cohort expansion. The dose escalation part is further divided into single-dose and multiple-dose administration.
In the cohort expansion part, only multiple doses. Receives: Drug: CS231295 |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of dose-limiting toxicity (DLT)
Measured: 34 days after, that is 6 days after single-dose and 28 days after first administration in multiple-dose
maximum tolerated dose (MTD)
Measured: dose escalation part, about 2 years
incidence of adverse events (AEs)
Number of participants with AE(s)
Measured: from first administration to 28 days after last administration or next anti-tumor therapy, whichever occurs first
Pharmacokinetic parameters: Time to Maximum Concentration (Tmax)
Measured: during treatment, up to 11 cycles, 28 days in one cycle
Pharmacokinetic parameters: Maximum Concentration (Cmax)
Measured: during treatment, up to 11 cycles, 28 days in one cycle
Pharmacokinetic parameters: Area Under the Concentration-time Curve(AUC)
Measured: during treatment, up to 11 cycles, 28 days in one cycle
Pharmacokinetic parameters: Trough Concentration (Ctrough)
Measured: during treatment, up to 11 cycles, 28 days in one cycle
Pharmacokinetic parameters: Accumulation Ratio (Rac)
Measured: during treatment, up to 11 cycles, 28 days in one cycle
Pharmacokinetic parameters: Elimination Half-life (t1/2)
Measured: during treatment, up to 11 cycles, 28 days in one cycle
Pharmacokinetic parameters: Clearance over Fractional Bioavailability (CL/F)
Measured: during treatment, up to 11 cycles, 28 days in one cycle
Pharmacokinetic parameters: Volume of Distribution at Steady State over Fractional Bioavailability (Vz/F)
Measured: during treatment, up to 11 cycles, 28 days in one cycle
Secondary outcomes (7)
Objective Response Rate (ORR)
Measured: during study, expected average one year
Disease control rate (DCR)
Measured: during study, expected average one year
Duration of Response (DOR)
Measured: during study, expected average one year
Time to Progression (TTP)
Measured: during study, expected average one year
Time to Response (TTR)
Measured: during study, expected average one year
progression-free survival (PFS)
Measured: during study, expected average one year
Overall Survival (OS)
Measured: during study, expected average one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2025
- Study start21 May 2025
- Primary completionApr 2029 (estimated)
- Study completionApr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeoplasmsStudies 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
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chipscreen Biosciences, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Wenbin Li, M.D., Principal investigator, Beijing Tiantan HospitalYing Cheng, M.D., Principal investigator, Jilin Provincial Tumor Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06902350
- Sponsor's protocol ID
- CS231295-101
- Status last verified
- May 2025
- First submitted
- 17 Mar 2025
- Last updated
- 25 May 2025
- 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 25 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of CS231295 in Subjects With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT06902350
- Acronym / sponsor ID
- CS231295-101
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Chipscreen Biosciences, Ltd.Industry (pharma, biotech, devices)
- Study start
- 21 May 2025 (actual)
- Primary completion
- Apr 2029 (estimated)
- Study completion
- Apr 2029 (estimated)
- First posted
- 30 Mar 2025 (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.
This trial is a single-arm, open-label, first-in-human study of CS231295, comprising two phases: dose escalation (including single-dose and multiple-dose) and cohort expansion. The Dose-Limiting Toxicity (DLT) observation period includes 6 days for single-dose and the first cycle (28 days) for multiple-dose. The overall study consists of screening period, treatment period, and follow-up period.
The primary objectives of this study are to evaluate the safety, tolerability and pharmacokinetic (PK) characteristics of CS231295 in patients with advanced solid tumors, and to recommended Phase 2 dose(s) (RP2D) of CS231295 in appropriate tumor(s).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CS231295 | Experimental | Drug: CS231295two phases: dose escalation and cohort expansion. The dose escalation part is further divided into single-dose and multiple-dose administration. In the cohort expansion part, only multiple doses. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Understand and sign the informed consent form voluntarily.
- ≥18 years old when signing the informed consent, regardless of sex.
- Have histologically or cytologically confirmed unresectable advanced, recurrent, or metastatic solid tumors (including but not limited to small cell lung cancer, glioblastoma, urothelial carcinoma, endometrial cancer, cervical cancer, ovarian cancer, breast cancer, and liver cancer) for which standard therapy has failed or was intolerable, and currently no standard treatment is available.
- For glioblastoma: at least one measurable intracranial tumor lesion according to the RANO 2.0 criteria. For other solid tumors: at least one measurable lesion according to RECIST v1.1 criteria. Note: Target lesions can be located in previously irradiated areas, but must be confirmed by imaging to show disease progression after radiation.
- For glioblastoma: KPS score ≥60. For other solid tumors: ECOG performance status of 0 or 1.
Key exclusion criteria (38 listed)
- Received any form of intracranial radiotherapy within 3 months prior to the first dose.
- Received any anti-tumor treatment (including but not limited to chemotherapy, targeted therapy, immunotherapy, cellular therapy, radiation therapy [see exclusion criterion #1 for head], endocrine anti-tumor therapy, tumor embolization) or unapproved investigational drugs or devices within 28 days prior to the first dose. Also, received Traditional Chinese Medicine (TCM) approved by the National Medical Products Administration (NMPA) for treating malignant tumors within 14 days prior to the first dose.
- Previously received Aurora kinase inhibitors.
- Used strong inducers or inhibitors of cytochrome P450 3A (CYP3A) enzymes within 14 days prior to the first dose or are still within 7 half-lives of such drugs (whichever is longer).
- For glioblastoma only: >5 mg/day dexamethasone or equivalent doses of other glucocorticoids for systemic treatment related to glioblastoma within 1 week prior to the first dose.
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 |
|---|---|---|
| CS231295oral tablet. Only one dose on C0D1 in single-dose period. Once daily from C1D1 until disease progression, death, intolerable toxicity, loss to follow-up, withdrawal of informed consent, or the end of the trial, whichever occurs first, in multiple-dose period in both escalation and cohort expansion phases. | Drug | CS231295 |
Primary outcome
incidence of dose-limiting toxicity (DLT)
Time frame: 34 days after, that is 6 days after single-dose and 28 days after first administration in multiple-dose
maximum tolerated dose (MTD)
Time frame: dose escalation part, about 2 years
incidence of adverse events (AEs)
Time frame: from first administration to 28 days after last administration or next anti-tumor therapy, whichever occurs first
Number of participants with AE(s)
Pharmacokinetic parameters: Time to Maximum Concentration (Tmax)
Time frame: during treatment, up to 11 cycles, 28 days in one cycle
Pharmacokinetic parameters: Maximum Concentration (Cmax)
Time frame: during treatment, up to 11 cycles, 28 days in one cycle
Pharmacokinetic parameters: Area Under the Concentration-time Curve(AUC)
Time frame: during treatment, up to 11 cycles, 28 days in one cycle
Pharmacokinetic parameters: Trough Concentration (Ctrough)
Time frame: during treatment, up to 11 cycles, 28 days in one cycle
Pharmacokinetic parameters: Accumulation Ratio (Rac)
Time frame: during treatment, up to 11 cycles, 28 days in one cycle
Pharmacokinetic parameters: Elimination Half-life (t1/2)
Time frame: during treatment, up to 11 cycles, 28 days in one cycle
Pharmacokinetic parameters: Clearance over Fractional Bioavailability (CL/F)
Time frame: during treatment, up to 11 cycles, 28 days in one cycle
Pharmacokinetic parameters: Volume of Distribution at Steady State over Fractional Bioavailability (Vz/F)
Time frame: during treatment, up to 11 cycles, 28 days in one cycle
7 secondary outcomes
Objective Response Rate (ORR)
Time frame: during study, expected average one year
Disease control rate (DCR)
Time frame: during study, expected average one year
Duration of Response (DOR)
Time frame: during study, expected average one year
Time to Progression (TTP)
Time frame: during study, expected average one year
Time to Response (TTR)
Time frame: during study, expected average one year
progression-free survival (PFS)
Time frame: during study, expected average one year
Overall Survival (OS)
Time frame: during study, expected average one year
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 25 May 2025.
- 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.
Wenbin Li, M.D. principal investigator
Beijing Tiantan Hospital
Ying Cheng, M.D. principal investigator
Jilin Provincial Tumor Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CS231295 in people with Neoplasms and Glioblastoma, Adult, run by Chipscreen Biosciences, Ltd. at 2 sites 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 15 inclusion and 38 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 25 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Xinhang Wang (+86 0755-36993500 ext. 3550, xinhwang@chipscreen.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of dose-limiting toxicity (DLT) (time frame: 34 days after, that is 6 days after single-dose and 28 days after first administration in multiple-dose). The study lists 11 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 25 May 2025.