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Not yet recruiting Phase 1 Interventional

A Study of CS231295 in Patients With Advanced Solid Tumors

ClinicalTrials.gov ID: NCT07612488

Public ClinicalTrials.gov record NCT07612488. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Nov 4, 2026, 7:42 AM EST

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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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT07612488
Recruitment status
Not yet recruiting
Study type
Interventional
Phase
Phase 1
Enrollment
42 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jun 2026 (Estimated)
Primary completion
Dec 2027 (Estimated)
Completion
Dec 2028 (Estimated)
Last update posted
May 28, 2026

2026 – 2028

United States locations

U.S. sites
4
U.S. states
4
U.S. cities
4
Facility City State ZIP Site status
Sarah Cannon Research Institute at HealthONE Denver Colorado 80218 —
Florida Cancer Specialists Sarasota Florida 34232 —
Dana Farber Cancer Institute Boston Massachusetts 02215 —
SCRI Oncology Partners Nashville Tennessee 37203 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT07612488, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted May 28, 2026 · Synced Nov 4, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT07612488 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →