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New treatment option for Advanced or Metastatic Solid Tumors With Homozygous MTAP Deletion
Official title A Phase I Study of SY-9453 in Patients With Advanced Solid Tumors
ClinicalTrials.gov ID: NCT07469982
What this study is testing
What is SY-9453?
SY-9453 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for advanced or metastatic solid tumors with homozygous mtap deletion.
Also referred to as SY-9453 capsules.
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 an open-label, single-arm, multicenter, dose-escalation and dose-expansion, phase I study to the safety, tolerability, pharmacokinetics, and preliminary efficacy of SY-9453 in patients with advanced solid tumors.
- Phase 1: an early, usually small safety study
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
- Patients must meet all of the following criteria to be eligible for this study:
- people voluntarily participated in this study and signed the written informed consent (ICF);
- Age ≥ 18 years at the time of signing the Informed Consent Form (ICF);
- Histologically or cytologically confirmed locally advanced solid tumor and disease progression or intolerance after adequate standard treatment, or...
- No blood products, hematopoietic growth factors (e.g., G-CSF, thrombopoietin, erythropoietin, platelet transfusion, whole blood transfusion, red...
You likely can't join if
- 1\. Patients previously treated with a MAT2A inhibitor or PRMT5 inhibitor. 2. History of allergy to any component or excipient of SY-9453 capsules...
- Small-molecule targeted drugs within 2 weeks(or 5 half-lives, whichever is shorter).
- Hormonal anti-tumor therapy within 2 weeks or as judged by the investigator.
- Chinese herbal medicine or preparations with indications for anti-tumor therapy or tumor adjuvant therapy within 2 weeks or as judged by the...
- Radiotherapy within 4 weeks (with 2 weeks if the radiotherapy was palliative stereotactic radiotherapy that did not involve the lungs, abdomen and...
- Chemotherapy: fluorouracil, leucovorin, and/or weekly paclitaxel with 2 weeks; nitrosourea or mitomycin C with 6 weeks; other chemotherapy with 3...
See the full eligibility criteria
Who can join
- Patients must meet all of the following criteria to be eligible for this study:
- people voluntarily participated in this study and signed the written informed consent (ICF);
- Age ≥ 18 years at the time of signing the Informed Consent Form (ICF);
- Histologically or cytologically confirmed locally advanced solid tumor and disease progression or intolerance after adequate standard treatment, or lack of standard treatment options. For people participating in the...
- No blood products, hematopoietic growth factors (e.g., G-CSF, thrombopoietin, erythropoietin, platelet transfusion, whole blood transfusion, red blood cell transfusion), or other drugs that correct abnormal blood counts...
- Renal function: Creatinine clearance (Ccr) ≥ 60 mL/min (calculated using the Cockcroft and Gault formula).
- Liver function: TBIL ≤ 1.5 × upper limit of normal (ULN), and AST and ALT ≤ 2.5 × ULN; in the presence of liver metastases, AST and ALT ≤ 5.0 × ULN, and serum albumin ≥ 30 g/L.
- Coagulation function: Activated Partial Thromboplastin Time (APTT) ≤ 1.5 × ULN, and International normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 × ULN (except for patients receiving anticoagulant therapy)...
What rules you out
- 1\. Patients previously treated with a MAT2A inhibitor or PRMT5 inhibitor. 2. History of allergy to any component or excipient of SY-9453 capsules. 3. Received the following treatments prior to the first dose:
- Small-molecule targeted drugs within 2 weeks(or 5 half-lives, whichever is shorter).
- Hormonal anti-tumor therapy within 2 weeks or as judged by the investigator.
- Chinese herbal medicine or preparations with indications for anti-tumor therapy or tumor adjuvant therapy within 2 weeks or as judged by the investigator.
- Radiotherapy within 4 weeks (with 2 weeks if the radiotherapy was palliative stereotactic radiotherapy that did not involve the lungs, abdomen and pelvis)
- Chemotherapy: fluorouracil, leucovorin, and/or weekly paclitaxel with 2 weeks; nitrosourea or mitomycin C with 6 weeks; other chemotherapy with 3 weeks.
- Other investigational drugs with 4 weeks.
- Biotherapy within 4 weeks(or 5 half-lives, whichever is longer)
- Immunotherapy within 4 weeks.
- Major surgery within 4 weeks (excluding central venous catheter insertion, bone marrow biopsy and gastric tube insertion).
- Radioactive Particle Therapy within 3 months.
- Radionuclide therapy within 3 months.
- Autotransplantation (including CAR-T therapy and other similar treatments) within 3 months. 4.Adverse events from prior anti-cancer therapies have not recovered to Grade ≤1 as defined by the National Cancer Institute...
- .Left ventricular ejection fraction (LVEF) ≤ 50%.
- . Heart failure, myocardial infarction, unstable angina with 6 months, or classified as New York Heart Association (NYHA) class II, III or IV congestive heart failure.
- . High-risk uncontrolled arrhythmias within 6 months: atrial tachycardia with a resting heart rate \>100 beats/min, significant ventricular arrhythmias (such as ventricular tachycardia), or high-grade atrioventricular...
- .History of Percutaneous Transluminal Coronary Angioplasty (PTCA) or stent implantation within 6 months.
- . Aortic stenosis.
- . Fridericia-corrected QT interval (QTcF) \> 470 msec (females) or 450 msec (males) at baseline (if QTcF prolongation suspected to be drug-induced is assessed as safe and controllable by the investigator, the patient...
- .Poorly controlled hypertension (systolic blood pressure ≥180 mmHg and/or diastolic blood pressure ≥110mmHg) or diabetes (fasting blood glucose ≥ 11.1mmol/L and/or HbA1c ≥ 8%).
- .Clinically significant active infection requiring systemic antibiotic, antiviral, or antifungal therapy.
- .Serous cavity effusion, or pleural effusion, ascites, or pericardial effusion poorly controlled after intervention (poorly controlled indicates significant increase in effusion within 2 weeks after drainage, with...
- Stroke occurred within 6 months before screening. Evidence of central nervous system bleeding on baseline MRI or CT scan (subject had asymptomatic grade 1 bleeding stable for less than 3 months postoperatively).
- . Presence of drug-resistant seizures.
- .Severe lung diseases, including but not limited to pulmonary embolism, severe asthma, chronic obstructive pulmonary disease (COPD), restrictive lung disease, or active pneumonia or interstitial pneumonia that occurred...
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, 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 Shanghai, 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.