A Study of CS231295 in Patients With Advanced Solid Tumors

Part of paid clinical trials in Denver, Colorado.

Sponsor
ThalassaX Therapeutics United States Ltd
Study ID
NCT07612488
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

  • Advance Solid Tumors
  • Advanced Malignant Solid Tumors

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Jun 30, 2026
Status verified
May 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2028

Study Design

Enrollment
42 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: CS231295
    Dose escalation

Primary Outcome Measure

Incidence and severity of adverse events (AEs) [ Time Frame: From first dose administration to 28 days after the end of treatment. ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Sarah Cannon Research Institute at HealthONEDenverColorado80218
Gerald Falchook, MD (PRINCIPAL_INVESTIGATOR)
Florida Cancer SpecialistsSarasotaFlorida34232
Judy Wang, MD (PRINCIPAL_INVESTIGATOR)
Dana Farber Cancer InstituteBostonMassachusetts02215
Alissa Cooper, MD (PRINCIPAL_INVESTIGATOR)
SCRI Oncology PartnersNashvilleTennessee37203
Meredith McKean, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Denver, CO

By research site
Sarah Cannon Research Institute at HealthONE· Denver, COFlorida Cancer Specialists· Sarasota, FLDana Farber Cancer Institute· Boston, MASCRI Oncology Partners· Nashville, TN

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