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a small molecular multi-target kinase inhibitor

Phase 1

Advance Solid Tumors | Small molecule | Oncology |United Therapeutics Corporation|Last Updated: May 28, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment42
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07612488A Study of CS231295 in Patients With Advanced Solid TumorsPHASE1 NOT YET_RECRUITING 42 — — Jun 1, 2026Dec 1, 2028May 28, 20264 United States
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Study Endpoints
Primary Endpoints
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.
Secondary Endpoints
Objective Response Rate (ORR)
During study, expected average one year.
Disease control rate (DCR)
During study, expected average one year.
Duration of Response (DOR)
During study, expected average one year.
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
CS231295EXPERIMENTALDose escalation
Interventions
NameTypeDescription
a small molecular multi-target kinase inhibitorDRUGCS231295 is a small-molecule, multi-target protein kinase inhibitor that exhibits balanced activity against both Aurora B kinase and VEGFR/PDGFR kinases.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites4

Inclusion Criteria: Patients are eligible to be included in the study only if all of the following criteria apply: 1. 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 t...

Countries:United States
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