A Study of CS231295 in Patients With Advanced Solid Tumors

NCT07612488 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: CS231295-US-101
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Advance Solid Tumors; Advanced Malignant Solid Tumors

Keywords

solid tumors; advanced malignant solid tumors; malignant tumors; advanced tumors

Outcome Measures

Primary Outcomes (11)

• Incidence and severity of adverse events (AEs)

  Incidence and severity of adverse events (AEs) according to CTCAE V5.0.

  From first dose administration to 28 days after the end of treatment.

• Dose Limiting Toxicity (DLT)

  Incidence and characteristics of DLTs

  34 days. From the first dose of 6-day single dose period to the last dose of the 28-day consecutive multiple dose period.

• 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 Outcomes (7)

• 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.

• Time to Progression (TTP)

  During study, expected average one year.

• Time to Response (TTR)

  During study, expected average one year.

Study Arms (1)

CS231295

EXPERIMENTAL

Dose escalation

Drug: a small molecular multi-target kinase inhibitor

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.

CS231295

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients are eligible to be included in the study only if all of the following criteria apply:
• 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 to performing any protocol-related procedures, including screening evaluations.
• Male or female ≥18 years at the time of Screening.
• Histologically or cytologically confirmed unresectable advanced, recurrent or metastatic solid tumors (including but not limited to small cell lung cancer (SCLC), brain gliomas, non-small cell lung cancer (NSCLC), pancreatic cancer, urothelial carcinoma, endometrial cancer, cervical cancer, ovarian cancer, breast cancer and liver cancer, etc.), who have failed or are intolerant to previous standard treatment (assessed by the investigator according to the diagnosis and treatment guidelines of the relevant disease) and currently have no standard treatment.
• 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.
• At least one measurable target lesion (glioma, according to RANO 2.0; other solid tumors according to RECIST v1.1).
• Note: The target lesion can be located in an area that has previously undergone radiotherapy. However, imaging examinations are required to confirm disease progression at the site after radiotherapy.
• Glioma: KPS score ≥ 60 points; other solid tumors: ECOG performance status score of 0 or 1 points.
• Life expectancy of ≥ 12 weeks.
• Major organ functions meet the following criteria:
• (No blood components, hematopoietic growth factors, albumin, or other drugs deemed corrective treatment by the investigators should be used within 14 days prior to the screening, except for iron supplements.)
• Hematology:
• Absolute neutrophil count (ANC) ≥ 1.5 × 10\^9/L,

You may not qualify if:

• Patients are excluded from the study if any of the following criteria apply:
• Received any form of intracranial radiotherapy within a specified time frame before the first dose of medication: 3 months for glioma and 2 weeks for other solid tumors.
• Patients have previously received treatment with Aurora kinase inhibitors.
• Has used a strong inducer or inhibitor of cytochrome P450 3A enzyme (CYP3A) within 14 days before the first dose of the study drug or is still within 7 half-lives of the drug (whichever is longer).
• Glioma: Use of \> 5 mg/d dexamethasone or equivalent doses of other glucocorticoids for systemic treatment related to glioma within 1 week before the first dose.
• Major surgical procedures (craniotomy, thoracotomy, or laparotomy) or severe unhealed wounds, ulcers, or fractures performed within 4 weeks before the first dose of study medication.
• Any unresolved toxicity from previous anticancer therapy, defined as toxicities not yet resolved to NCI CTCAE Grade ≤1, except for alopecia or laboratory values deemed by the investigator to be of no clinical significance.
• History of another primary malignancy except for
• Malignancy treated with curative intent and with no known active disease ≥ 5 years before the first dose of the study drug and of low potential risk for recurrence
• Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease
• Adequately treated carcinoma in situ without evidence of disease
• Advanced solid tumors other than glioma: Patients with active or untreated brain metastases, leptomeningeal metastases, spinal cord compression, or leptomeningeal carcinomatosis at the screening are excluded. Participants with previous brain metastases may participate only if they satisfy all of the following:
• Has completed treatment (e.g., whole brain radiation treatment \[WBRT\], stereotactic radiosurgery, or equivalent)
• Have stable disease for more than 4 weeks at the screening tumor assessment as confirmed by MRI or CT brain (defined as 2 brain images, both of which are obtained after treatment to the brain metastases. These imaging scans should both be obtained at least four weeks apart and show no evidence of intracranial progression).
• Have been either off corticosteroids or on a stable or decreasing dose of 10 mg daily prednisone (or equivalent) for at least 2 weeks before the first dose of study medications.

Sponsors & Collaborators

• ThalassaX Therapeutics United States Ltd: lead

Study Sites (4)

Sarah Cannon Research Institute at HealthONE

Denver, Colorado, 80218, United States

Location

Florida Cancer Specialists

Sarasota, Florida, 34232, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

SCRI Oncology Partners

Nashville, Tennessee, 37203, United States

Location

MeSH Terms

Conditions

Neoplasms

Central Study Contacts

Jason Tsai, MD

CONTACT

6505762793; jason_tsai@thalassaxus.com

Zhijian Li, MD

CONTACT

6092355494; zhijian_li@thalassaxus.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 3x3 dose escalation design

Study Record Dates

• First Submitted: May 20, 2026
• First Posted: May 28, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: May 28, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)