Study of CS231295 for Advanced Solid Tumors
This study is testing a new drug called CS231295 in people with advanced solid tumors that have not responded to standard treatments. CS231295 is a small molecule that works by blocking certain proteins (Aurora B kinase and VEGFR/PDGFR kinases) that can help cancer grow. The main goals of this study are to find out how safe CS231295 is, what side effects it might cause, and to determine the highest dose that can be given safely. To join, you must be at least 18 years old, have advanced solid tumors that are not treatable with other options, and meet certain health and performance criteria. The study is currently recruiting about 42 participants.
- Study design
- This is a Phase I, single-arm, open-label study, meaning all participants will receive CS231295, and both you and the study team will know which treatment you are getting. It is a dose-escalation study, starting with 20 mg, and aims to enroll about 42 participants.
- What's involved
- You will first have a 6-day period where you receive a single dose of CS231295. After that, you will receive CS231295 daily in 28-day cycles, continuing until your disease progresses, you experience unacceptable side effects, or you choose to stop.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your safety will be monitored from your first dose until 28 days after your last treatment. The maximum tolerated dose will be assessed over a period of up to 2 years.
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NCT07612488
A Study of CS231295 in Patients With Advanced Solid Tumors
Not Yet Recruiting
PHASE1Ages 18+InterventionalTreatmentThalassaX Therapeutics United States Ltd
~42 participants
Updated 2026-05-28 on ClinicalTrials.gov
What's tested:a small molecular multi-target kinase inhibitor
At a glance
Recruiting sites
0 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence and severity of adverse events (AEs)
Measured over From first dose administration to 28 days after the end of treatment.
+10 more outcomes measured
Conditions
Where it's being run
4 sites across 4 statesColorado1
Florida1
Massachusetts1
Tennessee1
Who to contact
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Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
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.
Recurrence is based on imaging or cell histopathology results. 4. At least one measurable target lesion (glioma, according to RANO 2.0; other solid tumors according to RECIST v1.1).
Absolute neutrophil count (ANC) ≥ 1.5 × 10\^9/L,
platelets ≥ 100 × 10\^9/L,
hemoglobin ≥ 100 g/L 2. 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) 3. 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). 4. 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. 8. 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. 9. 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).
What this trial measures
- Incidence and severity of adverse events (AEs)From first dose administration to 28 days after the end of treatment.
Incidence and severity of adverse events (AEs) according to CTCAE V5.0.
- Dose Limiting Toxicity (DLT)34 days. From the first dose of 6-day single dose period to the last dose of the 28-day consecutive multiple dose period.
Incidence and characteristics of DLTs
- Maximum Tolerated Dose (MTD)Dose escalation period. 2 years.
- Pharmacokinetic parameters: Time to Maximum Concentration (Tmax)During treatment, up to 11 cycles. 28 days in one cycle.
- Pharmacokinetic parameters: Maximum Concentration (Cmax)During treatment, up to 11 cycles. 28 days in one cycle.
- Pharmacokinetic parameters: Area Under the Concentration-time Curve (AUC)During treatment, up to 11 cycles. 28 days in one cycle.
- Pharmacokinetic parameters: Trough Concentration (Ctrough)During treatment, up to 11 cycles. 28 days in one cycle.
- Pharmacokinetic parameters: Accumulation Ratio (Rac)During treatment, up to 11 cycles. 28 days in one cycle.
- Pharmacokinetic parameters: Elimination Half-life (t1/2)During treatment, up to 11 cycles. 28 days in one cycle.
- Pharmacokinetic parameters: Clearance over Fractional Bioavailability (CL/F)During treatment, up to 11 cycles. 28 days in one cycle.
- Pharmacokinetic parameters: Volume of Distribution at Steady State over Fractional Bioavailability (Vz/F)During treatment, up to 11 cycles. 28 days in one cycle.