CS231295 for Cancer

Not yet recruiting at 3 trial locations
JT
ZL
Overseen ByZhijian Li, MD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the safety and optimal dosing of a new treatment, CS231295 (experimental treatment), for advanced solid tumors that cannot be surgically removed. It targets individuals who have tried standard treatments without success and have no other options available. Participants must have a confirmed solid tumor diagnosis, such as lung cancer or brain gliomas, and at least one measurable tumor. The study seeks to determine if CS231295 could be a potential treatment for these challenging cancer cases.

As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify if you must stop taking your current medications. However, you cannot have taken certain treatments like chemotherapy, immunotherapy, or strong CYP3A enzyme inducers or inhibitors within a specific period before starting the trial. It's best to discuss your current medications with the trial team.

Is there any evidence suggesting that CS231295 is likely to be safe for humans?

Research has shown that CS231295 is safe in early testing. Preclinical studies found that the drug was well-tolerated, with no severe side effects reported. The drug also demonstrates effective absorption, distribution, and elimination in the body.

CS231295 has shown the ability to cross the blood-brain barrier, a protective shield around the brain, which could aid in treating brain tumors. Currently in a Phase 1 trial, the drug is still undergoing safety testing in humans, but early research results are promising.12345

Why do researchers think this study treatment might be promising?

CS231295 is unique because it offers a novel approach to treating cancer by using a dose escalation method to determine the most effective and safe dosage for patients. Unlike standard chemotherapy, which targets rapidly dividing cells indiscriminately, CS231295 is designed to focus more specifically on cancer cells, potentially reducing side effects. Researchers are excited about this treatment because it could provide a more targeted and personalized therapy option, improving patient outcomes and quality of life.

What evidence suggests that CS231295 might be an effective treatment for cancer?

Research has shown that CS231295, the treatment under study in this trial, is a promising option for advanced solid tumors. It targets specific weaknesses in cancer cells, particularly in tumors with certain genetic issues. Studies demonstrated that CS231295 effectively stops tumor growth in lab experiments. It also shows potential for treating brain tumors because it can reach the brain and act on cancer cells there. Although more research is needed in humans, these findings strongly suggest its potential effectiveness.12678

Are You a Good Fit for This Trial?

This trial is for adults with advanced solid tumors that can't be removed by surgery, have come back or spread, and who have tried all standard treatments without success. Participants must be in reasonably good physical condition and have at least one tumor that can be measured.

Inclusion Criteria

At least one measurable target lesion according to RANO 2.0 for glioma or RECIST v1.1 for other solid tumors
Life expectancy of at least 12 weeks
Subject provides voluntary informed consent including compliance with protocol and informed consent form prior to any protocol-related procedures
See 10 more

Exclusion Criteria

History of drug or alcohol abuse affecting study participation
Investigator judgment of unsuitability for participation or unlikely compliance with study procedures
I have not had major surgery or serious unhealed wounds in the past 4 weeks.
See 25 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Single-dose Treatment

Participants receive a single dose of oral CS231295 on Day 1, with no additional doses through Day 6

6 days
1 visit (in-person)

Multiple-dose Treatment

Participants undergo a continuous multiple-dose treatment period with a treatment cycle of 28 days

28 days per cycle
4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • CS231295

Trial Overview

The study tests a new drug called CS231295, which targets multiple cancer-related proteins. All participants receive the drug at increasing doses to find the safest amount. There is no placebo group.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: CS231295Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

ThalassaX Therapeutics United States Ltd

Lead Sponsor

Citations

A Study of CS231295 in Patients With Advanced Solid ...

This is a Phase I, single-arm, open-label, dose-escalation, multicenter clinical study of CS231295 in patients with advanced solid malignant ...

Safety, Pharmacokinetics and Preliminary Efficacy of ...

The primary objectives of this study are to evaluate the safety, tolerability and pharmacokinetic (PK) characteristics of CS231295 in patients ...

Abstract 3061: CS231295, a novel AURKB-biased multi ...

CS231295, a novel AURKB-biased multi-kinase inhibitor, demonstrates synthetic lethality in RB1-deficient tumors and potent intracranial efficacy ...

CS-231295 - Drug Targets, Indications, Patents

This drug candidate exhibits significant synthetic lethal effects on tumors carrying particular genetic defects, providing a new treatment ...

Chipscreen Biosciences' Brain-Penetrant Aurora B ...

Despite continuous advancements in clinical treatments and efficacy, most cancers remain incurable. Drug resistance, recurrence, and metastasis ...

CS231295

Furthermore, CS231295 demonstrates good blood-brain barrier permeability, showing clear therapeutic advantages for both primary and metastatic brain tumors, and ...

Chipscreen Biosciences' Innovative Anti-Tumor Drug ...

In preclinical studies, CS231295 has shown significant pharmacodynamic activity, favorable pharmacokinetic properties, and a good safety profile ...

CS231295, a novel AURKB-biased multi-kinase inhibitor ...

CS231295, a novel AURKB-biased multi-kinase inhibitor, demonstrates synthetic lethality in RB1-deficient tumors and potent intracranial efficacy ...