RecruitingPhase 1Phase 2NCT06224387

CTS2190 Phase I /II Clinical Study in Patients

A Multi-center, Open-label, Dose Escalation/Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumor Activity of CTS2190 in Patients With Solid Tumors


Sponsor

CytosinLab Therapeutics Co., Ltd.

Enrollment

224 participants

Start Date

Jun 26, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

This is a first in human study in patients with advanced or metastatic solid tumors. The first part of the study is an open-label, dose escalation and the second part is an open label dose expansion in specific tumor types. The study drug, CTS2190, is a PRMT1 inhibitor administered orally. The study is planned to treat up to 224 participants.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This early-phase study is testing the safety and dosing of an experimental drug called CTS2190 in people with advanced solid tumors — including pancreatic cancer, non-small cell lung cancer, stomach cancer, and colorectal cancer — that have not responded to standard treatments. **You may be eligible if...** - You are 18 years old or older - You have advanced or metastatic solid tumors that have failed standard treatment options - Your tumor is measurable on imaging - Your overall health status is acceptable (ECOG 1 or below) - Your heart, liver, kidney, and blood function are adequate - Your expected survival is at least 12 weeks **You may NOT be eligible if...** - You are pregnant or breastfeeding - You have active brain metastases causing symptoms (stable treated brain metastases may be acceptable) - You have had a major cardiovascular event (heart attack, stroke) in the past 6 months - You have active hepatitis B, C, or HIV - You have a serious autoimmune disease - You have had recent major surgery (within 4 weeks) - You have uncontrolled infection, bleeding, or blood clotting disorders Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCTS2190 capsules

4-6 dose groups are pre-specified in Dose Escalation,and 4 arms in Dose Expansion.


Locations(2)

The First Affiliated Hospital of Henan University of Science and Technology

Luoyang, Henan, China

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

View Full Details on ClinicalTrials.gov

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NCT06224387


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