BridgeMD
New treatment option for Solid Tumors
Official title CTS2190 Phase I /II Clinical Study in Patients
ClinicalTrials.gov ID: NCT06224387
What this study is testing
What is CTS2190 capsules?
CTS2190 capsules is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for solid tumors.
Also referred to as CTS2190.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- people who meet all of the following criteria can be included in this study:
- Male or female ≥ 18 years of age at signing of ICF.
- Part 1: histologically or cytologically confirmed locally advanced or metastatic solid tumors at screening who cannot be treated surgically and have...
- At least one measurable tumor lesion at screening [according to RECIST V1.1 criteria (see appendix 1)].
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1 (Appendix 2) at screening.
You likely can't join if
- people should not participate in this clinical study if any of the following conditions is met:
- Female patients in pregnancy or lactation.
- Patients with dysphagia.
- Patients who cannot tolerate venipuncture or have a history of syncope judged by the investigator to be clinically significant.
- Uncontrolled tumor-related pain.
- Allergic or intolerant to the active ingredients or excipients of the investigational drug judged by the investigator.
See the full eligibility criteria
Who can join
- people who meet all of the following criteria can be included in this study:
- Male or female ≥ 18 years of age at signing of ICF.
- Part 1: histologically or cytologically confirmed locally advanced or metastatic solid tumors at screening who cannot be treated surgically and have failed standard treatment (PD during treatment or after the last...
- At least one measurable tumor lesion at screening [according to RECIST V1.1 criteria (see appendix 1)].
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1 (Appendix 2) at screening.
- With a life expectancy ≥ 12 weeks at screening.
- With good organ function at screening, including:
- Liver function: total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN) (if the following conditions occur, isolated bilirubin \>1.5 × ULN is acceptable if: bilirubin is fractionated and direct bilirubin \<35%, or...
- Renal function: blood creatinine ≤ 1.5 × ULN and creatinine clearance ≥ 50 mL/min [calculate the creatinine clearance using Cockcroft-Gault formula (appendix 3)];
- Hematology: platelet ≥ the lower limit of the laboratory normal range, and absolute neutrophil count (ANC) ≥ 1.5 × 109/L, and hemoglobin ≥ 100 g/dL;
- Cardiac function: QT interval corrected by Fridericia method (QTcF) ≤ 450 ms (male) or ≤ 470 ms (female) (see the appendix 3 for calculation formula).
- Coagulation function: International normalized ratio (INR) ≤ 1.5 × ULN, or activated partial thromboplastin time (APTT) ≤ 1.5 × ULN.
- Female patients of non-childbearing age or female patients of childbearing age who have negative pregnancy test results and promise to take sufficient and effective contraceptive measures or adhere to abstinence from...
- Patients who understand and voluntarily signs the ICF, are willing to and able to complete the scheduled visits, treatment plan, laboratory tests and other study procedures.
What rules you out
- people should not participate in this clinical study if any of the following conditions is met:
- Female patients in pregnancy or lactation.
- Patients with dysphagia.
- Patients who cannot tolerate venipuncture or have a history of syncope judged by the investigator to be clinically significant.
- Uncontrolled tumor-related pain.
- Allergic or intolerant to the active ingredients or excipients of the investigational drug judged by the investigator.
- Treatment with radiotherapy for the target lesion within 4 weeks before the first administration of the investigational drug, or accepted any anti-tumor drugs/ treatments (including but not limited to chemotherapy...
- Primary central nervous system (CNS) tumor or CNS metastasis at screening. The following patients can be considered for enrollment: after treatment and being stable for ≥ 3 months, patients who have completed the...
- Patients judged by the investigator to have uncontrolled pleural effusion, pericardial effusion, or peritoneal effusion (requiring repeated drainage, multiple times a month or more frequently) at screening. Allow...
- Patients with untreated or clinically symptomatic spinal cord compression that has not been controlled (except for patients who have received treatment and have stable symptoms, whose imaging examination shows that they...
- Patients with ≥ 2 malignant tumors within 5 years before the first administration. Except for cured early-stage malignancies (carcinoma in situ or stage I tumor), such as adequately treated cervical carcinoma in situ...
- Patients who are found to have active pulmonary tuberculosis infection within 1 year before enrollment through medical history, or those with a history of active pulmonary tuberculosis infection more than one year ago...
- Interstitial lung disease or interstitial pneumonia, including clinically significant radiation pneumonia (i.e., affecting activities of daily living or requiring intervention).
- Severe infection within 4 weeks before the first administration, including but not limited to bacteremia and severe pneumonia, etc. requiring hospitalization; CTCAE ≥ grade 2 active infection requiring systemic...
- History of serious cardiovascular and cerebrovascular diseases, including but not limited to serious cardiac rhythm or conduction abnormalities, such as ventricular arrhythmia requiring clinical intervention, degree...
- Positive hepatitis B virus surface antigen (HBsAg) and the number of copies of hepatitis B virus (HBV) deoxyribonucleic acid (DNA) ≥ 500 IU/mL (or 2500 copies, or the lower limit of the positive detection value of the...
- Patients who have active diseases or a history of autoimmune diseases that may relapse (such as systemic lupus erythematosus, rheumatoid arthritis, vasculitis, etc.) at screening, except patients suffering clinically...
- History of immunodeficiency, including HIV positive, or those suffering from other acquired or congenital immunodeficiency diseases, or with a history of allograft. Autotransplantation should be completed at least 3...
- Those who had clinically significant hemorrhage symptoms within 3 months before the first administration. Patients who significantly coughed up blood within 4 weeks before the first administration of the investigational...
- Patients who have received other unlisted clinical investigational drugs or treatments within 4 weeks (or 5 drug half-lives, whichever is longer) before the first administration.
- Patients who have used live vaccine or attenuated vaccine within 4 weeks before the first administration, or plan to use live vaccine or attenuated vaccine during the study period.
- Patients who have used potent cytochrome enzyme (CYP)3A4 inhibitors or inducers within 2 weeks before the first administration, or need to use potent CYP3A4 inhibitors or inducers until 7 days after the last dose (see...
- Major surgery (except for surgery for diagnostic purposes) within 4 weeks before the first administration, or expected to undergo major surgery (except for surgery for diagnostic purposes) during the study period, or...
- Adverse reactions from previous anti-tumor treatment have not recovered to ≤ CTCAE V5.0 grade 1 (except for alopecia and grade 2 neurotoxicity caused by chemotherapy drugs, grade 2 hypothyroidism caused by anti-tumor...
- Patients who are judged by the investigator to have a history of other serious systemic diseases, or not suitable for participating in the trial for any other reason (the patient has mental illness, alcohol abuse, drug...
The study team makes the final eligibility decision.
Where it's taking place
- Luoyang, Henan, China
- Hangzhou, Zhejiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Luoyang, Henan, China; Hangzhou, Zhejiang, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.