Actively Recruiting
CTS2190 Phase I /II Clinical Study in Patients
Led by CytosinLab Therapeutics Co., Ltd. · Updated on 2024-08-23
224
Participants Needed
2
Research Sites
122 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
CTS2190 Phase I /II Clinical Study in Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 years or older at signing informed consent.
- For Part 1: histologically or cytologically confirmed locally advanced or metastatic solid tumors that cannot be treated surgically and have failed, cannot tolerate, or refuse standard treatment.
- For Part 2: histologically or cytologically confirmed advanced solid tumors (including pancreatic cancer, non-small cell lung cancer, gastric cancer, colorectal cancer) that cannot be treated surgically and have failed, cannot tolerate, or refuse standard treatment.
- At least one measurable tumor lesion according to RECIST V1.1 criteria.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at screening.
- Life expectancy of at least 12 weeks.
- Good organ function, including liver, renal, hematologic, cardiac, and coagulation function within specified limits.
- Female patients of non-childbearing age or childbearing age with negative pregnancy tests and agreement to use effective contraception or abstinence during and 90 days after treatment; male patients agreeing to use contraception or abstinence during and 90 days after treatment.
- Ability and willingness to understand and voluntarily sign informed consent and complete scheduled visits, treatment, laboratory tests, and study procedures.
You will not qualify if you...
- Female patients who are pregnant or breastfeeding.
- Patients with difficulty swallowing (dysphagia).
- Patients unable to tolerate venipuncture or with a clinically significant history of syncope.
- Uncontrolled tumor-related pain.
- Allergy or intolerance to investigational drug components.
- Radiotherapy to target lesion within 4 weeks before treatment or recent anti-tumor therapies within specified washout periods.
- Primary central nervous system tumor or CNS metastasis unless stable after treatment for at least 3 months.
- Uncontrolled pleural, pericardial, or peritoneal effusion requiring frequent drainage.
- Untreated or unstable spinal cord compression.
- History of two or more malignant tumors within 5 years except certain early-stage cancers.
- Active or inadequately treated pulmonary tuberculosis.
- Interstitial lung disease or clinically significant radiation pneumonia.
- Recent severe infections requiring hospitalization or systemic antibiotics.
- Serious cardiovascular or cerebrovascular diseases within 6 months or uncontrolled hypertension.
- Positive hepatitis B or C virus tests with active infection or history of liver cirrhosis.
- Active or relapsing autoimmune diseases except stable autoimmune thyroid disorder.
- Immunodeficiency including HIV positive status.
- Recent clinically significant bleeding or thrombotic events.
- Use of other investigational drugs, live vaccines, or potent CYP3A4 modulators within specified time frames.
- Recent major surgery or planned surgery during the study.
- Unresolved adverse reactions from previous anti-tumor treatments above specified severity.
- Other serious systemic diseases or conditions affecting compliance or study interpretation as judged by the investigator.
AI-Screening
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Trial Site Locations
Total: 2 locations
1
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan, China, 471000
Actively Recruiting
2
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China, 310022
Actively Recruiting
Research Team
X
Xing S N, Master
CONTACT
S
Song Z B, Docotor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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