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Advance Solid TumorsPhase 1NCT07612488

A Study of CS231295 in Patients With Advanced Solid Tumors

A Phase 1 study testing a small molecular multi-target kinase inhibitor in people with Advance Solid Tumors and Advanced Malignant Solid Tumors, run by ThalassaX Therapeutics United States Ltd at 4 sites in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

This is a Phase I, single-arm, open-label, dose-escalation, multicenter clinical study of CS231295 in patients with advanced solid malignant tumors. Eligible patients must be 18 years or older and have histologically or cytologically confirmed unresectable advanced, recurrent, or metastatic solid tumors, who have… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
a small molecular multi-target kinase inhibitor
Could I receive a placebo?
No, everyone receives an active treatment
How many people
42 participants
Where
4 sitesUnited States
Study dates
Jun 2026to Dec 2028
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

  • Patients are eligible to be included in the study only if all of the following criteria apply:
  • Subject provides voluntary informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol prior to performing any protocol-related procedures, including screening evaluations.
  • Male or female ≥18 years at the time of Screening.
  • Histologically or cytologically confirmed unresectable advanced, recurrent or metastatic solid tumors (including but not limited to small cell lung cancer (SCLC), brain gliomas, non-small cell lung cancer (NSCLC), pancreatic cancer, urothelial carcinoma, endometrial cancer, cervical cancer, ovarian cancer, breast cancer and liver cancer, etc.), who have failed or are intolerant to previous standard treatment (assessed by the investigator according to the diagnosis and treatment guidelines of the relevant disease) and currently have no standard treatment.
  • Treatment failure must be documented by clear imaging or cell histopathology (such as cytology reports of new ascites or pleural effusion) to prove disease progression.
  • Intolerance is defined as the termination of treatment due to adverse events that occur during treatment.
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  • Recurrence is based on imaging or cell histopathology results.
  • At least one measurable target lesion (glioma, according to RANO 2.0; other solid tumors according to RECIST v1.1).
  • Note: The target lesion can be located in an area that has previously undergone radiotherapy. However, imaging examinations are required to confirm disease progression at the site after radiotherapy.
  • Glioma: KPS score ≥ 60 points; other solid tumors: ECOG performance status score of 0 or 1 points.
  • Life expectancy of ≥ 12 weeks.
  • Major organ functions meet the following criteria:
  • (No blood components, hematopoietic growth factors, albumin, or other drugs deemed corrective treatment by the investigators should be used within 14 days prior to the screening, except for iron supplements.)
  • Hematology:
  • Absolute neutrophil count (ANC) ≥ 1.5 × 10^9/L,
  • platelets ≥ 100 × 10^9/L,
  • hemoglobin ≥ 100 g/L
  • Biochemistry:
  • Total serum bilirubin ≤ 1.5 x ULN (< 3.0 x ULN for patients with Gilbert's syndrome).
  • In patients without hepatic metastasis: ALT and AST ≤1.5 × ULN.
  • In patients with hepatic metastases, ALT and AST ≤3 × ULN.
  • Measured or calculated creatinine clearance > 60 mL/min (according to the Cockcroft-Gault equation, using actual body weight)
  • Coagulation Function: International Normalized Ratio (INR) < 1.5 × ULN; Prothrombin time (PT) and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN (for subjects receiving prophylactic anticoagulation therapy, the investigator should judge that both INR and APTT are within the safe and effective therapeutic range).
  • Urine protein < 2+ by urinalysis. If patients have urine protein ≥2+ by urinalysis, a 24-hour urine protein quantification test should be performed. The patient cannot be enrolled if the quantified urine protein is ≥1 g/24 h. The patient can still be enrolled if the quantified urine protein is <1 g/24 h.
  • Women of childbearing potential (WOCBP) must be willing and able to take highly effective contraceptive measures during the entire study treatment period and for 12 weeks after the last dose of the study drug (see Appendix 13.3 for details). Women of childbearing potential include premenopausal and not sterilized (by hysterectomy, bilateral ligation of fallopian tubes, or bilateral oophorectomy) females who have passed menarche.
  • Male patients must be willing and able to use male condoms and their female partners who are WOCBP during the entire study treatment and for the 12 weeks after the last dose of the study drug (see Appendix 13.3 for details).

Who cannot join

  • Patients are excluded from the study if any of the following criteria apply:
  • Received any form of intracranial radiotherapy within a specified time frame before the first dose of medication: 3 months for glioma and 2 weeks for other solid tumors.
  • Any prior anti-tumor treatment such as radiotherapy (exclusion criterion #1 if intracranial radiotherapy), chemotherapy, immunotherapy, targeted therapy, cell therapy, endocrine anti-tumor therapy, tumor embolization, clinical trial drugs or devices that have not been approved for marketing, etc., within 28 days before the first medication.
  • Patients have previously received treatment with Aurora kinase inhibitors.
  • Has used a strong inducer or inhibitor of cytochrome P450 3A enzyme (CYP3A) within 14 days before the first dose of the study drug or is still within 7 half-lives of the drug (whichever is longer).
  • Glioma: Use of > 5 mg/d dexamethasone or equivalent doses of other glucocorticoids for systemic treatment related to glioma within 1 week before the first dose.
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  • Major surgical procedures (craniotomy, thoracotomy, or laparotomy) or severe unhealed wounds, ulcers, or fractures performed within 4 weeks before the first dose of study medication.
  • Any unresolved toxicity from previous anticancer therapy, defined as toxicities not yet resolved to NCI CTCAE Grade ≤1, except for alopecia or laboratory values deemed by the investigator to be of no clinical significance.
  • History of another primary malignancy except for
  • Malignancy treated with curative intent and with no known active disease ≥ 5 years before the first dose of the study drug and of low potential risk for recurrence
  • Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease
  • Adequately treated carcinoma in situ without evidence of disease
  • Advanced solid tumors other than glioma: Patients with active or untreated brain metastases, leptomeningeal metastases, spinal cord compression, or leptomeningeal carcinomatosis at the screening are excluded. Participants with previous brain metastases may participate only if they satisfy all of the following:
  • Has completed treatment (e.g., whole brain radiation treatment [WBRT], stereotactic radiosurgery, or equivalent)
  • Have stable disease for more than 4 weeks at the screening tumor assessment as confirmed by MRI or CT brain (defined as 2 brain images, both of which are obtained after treatment to the brain metastases. These imaging scans should both be obtained at least four weeks apart and show no evidence of intracranial progression).
  • Have been either off corticosteroids or on a stable or decreasing dose of 10 mg daily prednisone (or equivalent) for at least 2 weeks before the first dose of study medications.
  • Have been off anticonvulsants for at least 2 weeks before the first dose of study medications.
  • Combined with meningeal metastasis, except for glioma.
  • Has severe brain herniation or a risk of brain herniation.
  • Glioma: had a chip implant placed during glioma surgery.
  • Pleural effusion, ascites, or pericardial effusion that have been drained within 1 month before the first dose of the study drug, or significant clinical symptoms (such as chest tightness, shortness of breath, dyspnea, etc.).
  • Uncontrolled or significant cardiovascular diseases, including:
  • New York Heart Association (NYHA) grade II or higher congestive cardiac failure, unstable angina pectoris, and/or myocardial infarction within the 6 months prior to the first dose of the investigational drug, clinically significant arrhythmia unable to be controlled with medical treatment or left ventricular ejection fraction (LVEF) < 50% at screening.
  • Primary cardiomyopathies (e.g., dilated cardiomyopathy, hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, restrictive cardiomyopathy, indeterminate cardiomyopathy).
  • Clinically significant history of prolonged QTc interval, or QTcF interval ≥470 ms, regardless of sex, during screening. If the report does not include a QTcF result, it must be calculated using the Fridericia correction formula (Fridericia QTc = QT/RR^0.33).
  • Coronary heart disease with symptoms requiring medication.
  • Major cerebrovascular accidents (including cerebral hemorrhage, transient ischemic attack, etc.) within 6 months before the first medication.
  • Patient has hypertension at screening (defined as systolic blood pressure (SBP) ≥140 mmHg, diastolic blood pressure (DBP) ≥90 mmHg). [Patients with a known history of hypertension may be included if their blood pressure is well controlled on a single anti-hypertensive medication (SBP <140 mmHg and DBP <90 mmHg at screening). Additionally, these patients must not have experienced any changes in their blood pressure medication for at least three months prior to screening due to poor blood pressure control.]
  • Other cardiovascular diseases that the investigator judge to be unsuitable for inclusion in the study
  • Poorly controlled diabetes (fasting blood glucose > 10 mmol/L).
  • Clinically significant gastrointestinal abnormalities that may affect the study drug's intake, transport, or absorption (e.g., inability to swallow, chronic diarrhea, intestinal obstruction, or having undergone a total gastrectomy), as determined by the investigator.
  • Clinically significant hemoptysis or tumor bleeding occurred within 14 days before the first medication, or history of active bleeding within 2 months prior to enrollment, or are currently taking anticoagulant drugs, such as warfarin, Phenprocoumon (prophylactic use of low-dose aspirin, low molecular weight heparin is permitted), or have a definite predisposition to bleeding as determined by the investigator (e.g., esophageal varix associated with bleeding risk, local active ulcer lesions, positive occult fecal blood that cannot rule out gastrointestinal bleeding, and imaging evidence indicating tumor invasion or infiltration of large blood vessels).
  • History of severe thromboembolic events (such as arterial thrombotic events, pulmonary embolism, or deep vein thrombosis) occurred within 6 months prior to the initiation of the first medication. Thrombosis of implanted venous infusion ports or catheters, superficial venous thrombosis, or thromboembolism that is assessed by the investigator to be stable and does not require emergency medical intervention during the expected trial period is not considered "serious" thromboembolism.
  • Ongoing or active infections that require intravenous systemic treatment during the screening period. Severe infection within 28 days before the first medication (including but not limited to hospitalization due to infection, bacteremia, or severe pneumonia complications). Prophylactic antibiotic treatment (such as to prevent urinary tract infection or acute exacerbation of chronic obstructive pulmonary disease) can be included.
  • Active tuberculosis infection (clinical evaluation that may include clinical history, physical examination, radiographic findings, or tuberculosis testing in accordance with local practice), currently receiving anti-tuberculosis treatment or having received anti-tuberculosis treatment within 1 year prior to the first use of the medication.
  • Active hepatitis during the screening period: Hepatitis B surface antigen (HBsAg) positive with positive virus replication or hepatitis B core antibody (HBcAb) positive with positive virus replication. Hepatitis C antibody (HCV-Ab) positive with positive virus replication.
  • HIV test positive or active syphilis infection (syphilis specific antibody and non-specific antibody positive) during screening.
  • Known allergy or hypersensitivity to any of the study drugs or the study drug excipients.
  • History of allogenic organ transplantation or allogeneic hematopoietic stem cell transplantation.
  • History of drug or alcohol abuse disorders that may affect study participation and clinical outcomes according to the investigator's judgment.
  • Mental or cognitive disorders that could limit their understanding, execution, and compliance with the informed consent form and the study.
  • Pregnant or lactating women. Female participants of childbearing potential or male participants with partners of childbearing potential who are unwilling or unable to use effective contraception from 7 days before the first dose of medication until 3 months after the end of treatment. Female participants of childbearing potential with a positive pregnancy test result within 7 days before the first dose of medication.
  • The investigator determined that the patient was unsuitable for participation in the study and was unlikely to comply with the study's procedures, restrictions, and requirements.

Trial locations and contacts

4 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Jason Tsai, MD contact

6505762793

jason_tsai@thalassaxus.com

Zhijian Li, MD contact

6092355494

zhijian_li@thalassaxus.com

United States4 sites

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215

    Alissa Cooper, MD

  • Sarah Cannon Research Institute at HealthONE

    Denver, Colorado, 80218

    Gerald Falchook, MD

  • SCRI Oncology Partners

    Nashville, Tennessee, 37203

    Meredith McKean, MD

  • Florida Cancer Specialists

    Sarasota, Florida, 34232

    Judy Wang, MD

Other trials in United States

About this study

Official title: A Phase 1, Single-Arm, Open-Label, Dose-Escalation, Multicenter Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of CS231295 in Patients With Advanced Solid Malignant Tumors

This is a Phase I, single-arm, open-label, dose-escalation, multicenter clinical study of CS231295 in patients with advanced solid malignant tumors.

Eligible patients must be 18 years or older and have histologically or cytologically confirmed unresectable advanced, recurrent, or metastatic solid tumors, who have failed or are intolerant to previous standard treatments and currently have no other standard treatment options available. Patients should have at least one measurable target lesion (glioma, according to RANO 2.0; other solid tumors according to RECIST v1.1) and a Karnofsky Performance Status (KPS) score ≥ 60 (glioma) or an ECOG Performance Status score of 0 or 1 (other solid tumors).

After screening, eligible patients will be enrolled sequentially in the dose-escalating cohorts.

Read the detailed description

In this dose-escalation study, the "3+3" design will be employed for dose escalation decisions. 4 dose groups have been preset: 20 mg, 30 mg, 40 mg, 50 mg[LA2.1]. The starting dose is 20 mg, with each dose cohort enrolling 3-6 subjects. Each subject can participate in only one dosage group of the study. During the dose escalation, depending on the observed results of safety, pharmacokinetics (PK), and pharmacodynamics (PD), dose levels may be adjusted or removed, additional dose levels may be added and explored, including intermediate or higher dose levels or other dosing regimens. The dose escalation study includes a single-dose treatment period (C0) and a multiple-dose treatment period (C1, C2, …). During the treatment, subjects will first undergo a 6-day single-dose treatment period. Each subject will receive a single dose of oral CS231295 on Day 1 of the study, with no additional doses administered through Day 6. All subjects in each cohort (3 to 6 subjects) will initiate this single-dose period, followed by a continuous multiple-dose treatment period with a treatment cycle of 28 days and no drug-free intervals.

Patients continue the treatment cycle until disease progression per investigator assessment, unacceptable toxicity, death, withdrawal of consent, study termination, or other discontinuation criteria are met (whichever occurs first).

Being tested
a small molecular multi-target kinase inhibitor
Keywords
solid tumors, advanced malignant solid tumors, malignant tumors, advanced tumors
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • a small molecular multi-target kinase inhibitorDrug

    CS231295 is a small-molecule, multi-target protein kinase inhibitor that exhibits balanced activity against both Aurora B kinase and VEGFR/PDGFR kinases.

Study groups in NCT07612488
Study groupRoleWhat they receive
CS231295ExperimentalDose escalation
Receives: Drug: a small molecular multi-target kinase inhibitor

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence and severity of adverse events (AEs)

    Incidence and severity of adverse events (AEs) according to CTCAE V5.0.

    Measured: From first dose administration to 28 days after the end of treatment.

  2. Dose Limiting Toxicity (DLT)

    Incidence and characteristics of DLTs

    Measured: 34 days. From the first dose of 6-day single dose period to the last dose of the 28-day consecutive multiple dose period.

  3. Maximum Tolerated Dose (MTD)

    Measured: Dose escalation period. 2 years.

  4. Pharmacokinetic parameters: Time to Maximum Concentration (Tmax)

    Measured: During treatment, up to 11 cycles. 28 days in one cycle.

  5. Pharmacokinetic parameters: Maximum Concentration (Cmax)

    Measured: During treatment, up to 11 cycles. 28 days in one cycle.

  6. Pharmacokinetic parameters: Area Under the Concentration-time Curve (AUC)

    Measured: During treatment, up to 11 cycles. 28 days in one cycle.

  7. Pharmacokinetic parameters: Trough Concentration (Ctrough)

    Measured: During treatment, up to 11 cycles. 28 days in one cycle.

  8. Pharmacokinetic parameters: Accumulation Ratio (Rac)

    Measured: During treatment, up to 11 cycles. 28 days in one cycle.

  9. Pharmacokinetic parameters: Elimination Half-life (t1/2)

    Measured: During treatment, up to 11 cycles. 28 days in one cycle.

  10. Pharmacokinetic parameters: Clearance over Fractional Bioavailability (CL/F)

    Measured: During treatment, up to 11 cycles. 28 days in one cycle.

  11. 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)

  1. Objective Response Rate (ORR)

    Measured: During study, expected average one year.

  2. Disease control rate (DCR)

    Measured: During study, expected average one year.

  3. Duration of Response (DOR)

    Measured: During study, expected average one year.

  4. Time to Progression (TTP)

    Measured: During study, expected average one year.

  5. Time to Response (TTR)

    Measured: During study, expected average one year.

  6. Progression-free survival (PFS)

    Measured: During study, expected average one year.

  7. 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.

  1. First posted28 May 2026
  2. Study startJun 2026 (estimated)
  3. Primary completionDec 2027 (estimated)
  4. Study completionDec 2028 (estimated)

Resources

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
Single group
Model description
3x3 dose escalation design
Masking
None (open label)
Enrolment
42 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07612488
Sponsor's protocol ID
CS231295-US-101
Status last verified
May 2026
First submitted
20 May 2026
Last updated
28 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing a small molecular multi-target kinase inhibitor in people with Advance Solid Tumors and Advanced Malignant Solid Tumors, run by ThalassaX Therapeutics United States Ltd at 4 sites in United States.

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 26 inclusion and 43 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: opening soon, as of the sponsor's last update on 28 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. 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 Jason Tsai, MD (6505762793, jason_tsai@thalassaxus.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence and severity of adverse events (AEs) (time frame: From first dose administration to 28 days after the end of treatment.). 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?

On the ClinicalTrials.gov record for NCT07612488.

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 28 May 2026.

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