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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

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Market & Valuation

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Trial Design

UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment42

FDA Designations

No designations recorded

Clinical trial landscape

a small molecular multi-target kinase inhibitor · 1 trial · 2 indications

Phase 1 1
NCT07612488A Study of CS231295 in Patients With Advanced Solid TumorsAdvance Solid Tumors
NOT YET_RECRUITING42 Analytics
PHASE1NOT YET_RECRUITING
A Study of CS231295 in Patients With Advanced Solid Tumors
Advance Solid Tumors
NCT0761248842
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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 to 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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Frequently asked questions about a small molecular multi-target kinase inhibitor

What is CS231295 used for?

CS231295 is an investigational small molecule multi-target kinase inhibitor being studied for the treatment of advanced solid tumors, including advanced malignant solid tumors. It is currently in Phase 1 clinical development and has not been approved by the FDA.

What does CS231295 target?

CS231295 is a small molecule multi-target kinase inhibitor, meaning it targets multiple kinases involved in tumor growth and progression. The specific kinases it inhibits have not been disclosed, but its multi-target mechanism is intended to disrupt cancer cell signaling pathways.

Who is developing CS231295?

CS231295 is being developed by United Therapeutics Corporation, a biopharmaceutical company listed on the NASDAQ under the ticker symbol UTHR. The company is conducting a Phase 1 clinical trial to evaluate the drug in patients with advanced solid tumors.

What phase is CS231295 in?

CS231295 is in Phase 1 clinical development. It is an investigational drug and has not yet been approved by the FDA. The ongoing Phase 1 trial is designed to assess its safety, tolerability, and preliminary efficacy in patients with advanced solid tumors.

What clinical trials is CS231295 in?

CS231295 is being evaluated in a single Phase 1 clinical trial with the identifier NCT07612488, titled 'A Study of CS231295 in Patients With Advanced Solid Tumors.' The trial is not yet recruiting and plans to enroll 42 participants in the United States.

Is CS231295 the same as any other drug?

CS231295 is a unique investigational compound and no alternative names have been reported. It is distinct from other kinase inhibitors and is being developed specifically for advanced solid tumors by United Therapeutics Corporation.