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A Multi-center, Open-label, Dose Escalation and Expansion Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-tumor Activity of CTS2190 in Patients With Solid Tumors
Led by CytosinLab Therapeutics Co., Ltd. · Updated on 2024-08-23
224
Participants Needed
2
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating CTS2190, an oral PRMT1 inhibitor, in patients with advanced or metastatic solid tumors in this open-label Phase 1/2 clinical trial. The study includes a dose escalation phase for patients with various solid tumors who have not responded to or cannot tolerate standard treatments, followed by a dose expansion phase focusing on specific tumor types such as pancreatic cancer, non-small cell lung cancer, and triple-negative breast cancer. The trial aims to assess the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of CTS2190 in up to 224 participants. The study consists of two parts: Part 1 is a dose escalation with 4-6 dose groups, and Part 2 is a dose expansion with 4 arms. Participants receive oral CTS2190 capsules and may continue treatment as long as they tolerate the drug and do not experience disease progression. The treatment cycles are 21 days long, and doses are adjusted during the escalation phase to find the maximum tolerated dose and the recommended phase 2 dose. Participants will be involved from 28 days before the first dose until withdrawal, treatment end, loss to follow-up, death, 48 weeks of continuous treatment, or study end. During the trial, researchers monitor tumor response every 6 weeks using objective response rates and assess safety through adverse event tracking. Pharmacokinetic and pharmacodynamic evaluations occur at specified time points to understand how the drug is processed and affects the body. Regular laboratory tests, ECGs, and physical exams are conducted to ensure participant safety throughout the study.
CONDITIONS
Brief 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 of informed consent
- Confirmed locally advanced or metastatic solid tumors not treatable surgically
- Failed, cannot tolerate, refuse, or have no effective standard treatment available
- At least one measurable tumor lesion according to RECIST V1.1 criteria
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Life expectancy of at least 12 weeks
- Good organ function including liver, kidney, hematology, cardiac, and coagulation parameters
- Female patients of non-childbearing age or with negative pregnancy test and effective contraception; males must use effective contraception
- Ability and willingness to complete scheduled visits, treatment, and study procedures
You will not qualify if you...
- Pregnant or lactating female patients
- Patients with difficulty swallowing (dysphagia)
- Patients unable to tolerate venipuncture or with significant history of fainting
- Uncontrolled tumor-related pain
- Allergic or intolerant to investigational drug ingredients
- Recent radiotherapy within 4 weeks or anti-tumor treatments within 5 half-lives before first dose
- Primary CNS tumor or active CNS metastasis unless stable and treated
- Uncontrolled pleural, pericardial, or peritoneal effusion requiring frequent drainage
- Untreated or symptomatic spinal cord compression
- More than two malignant tumors within 5 years except certain early-stage cancers
- Active or untreated pulmonary tuberculosis
- Interstitial lung disease or significant radiation pneumonia
- Severe infection requiring hospitalization within 4 weeks or active infection requiring antibiotics within 2 weeks
- Serious cardiovascular or cerebrovascular diseases or uncontrolled hypertension
- Active hepatitis B or C infection, liver cirrhosis, or active syphilis
- Active or history of autoimmune diseases except stable thyroid disorder
- History of immunodeficiency including HIV or recent transplantation
- Recent significant bleeding or thrombosis events or current anticoagulant treatment
- Participation in other clinical investigational drugs within 4 weeks
- Use of live or attenuated vaccines within 4 weeks or planned during study
- Use of potent CYP3A4 inhibitors or inducers within 2 weeks before first dose or until 7 days after last dose
- Major surgery within 4 weeks before first dose or planned during study
- Unresolved adverse reactions from previous anti-tumor treatments above specified severity
- Other serious systemic diseases or conditions interfering with study participation or results, including mental illness, substance abuse, or poor compliance
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 48 weeks or until disease progression, withdrawal, loss to follow-up, or death
Participants receive oral CTS2190 capsules in dose escalation or dose expansion groups. Treatment continues until disease progression, withdrawal, or up to 48 weeks.
Visits every 6 weeks for assessments; pharmacokinetic and pharmacodynamic sampling on specified days within treatment cycles
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
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Research Team
X
Xing S N, Master
S
Song Z B, Docotor
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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