Actively Recruiting
A Multi-center, Open-label, Phase I/II Study to Evaluate Safety, Pharmacokinetics and Anti-tumor Activity of CTS3497 in Patients With MTAP Deficient Advanced Solid Tumors and Lymphomas
Led by CytosinLab Therapeutics Co., Ltd. · Updated on 2025-05-14
224
Participants Needed
1
Research Sites
25 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying CTS3497 in patients with metastatic or locally advanced solid tumors and lymphomas that lack the enzyme methylthioadenosine phosphorylase (MTAP). This study has two phases: Phase I focuses on evaluating safety, tolerability, pharmacokinetics, pharmacodynamics, and determining the maximum tolerated dose or recommended dose for Phase II. Phase II aims to assess the effectiveness and safety of CTS3497 in this patient group. Participants will receive CTS3497 orally in capsule form. Phase I includes a dose escalation with 7 pre-set dose groups followed by a dose expansion with 2 to 3 dose groups. Phase II involves administering the recommended Phase II dose to patients with MTAP homozygous deletion across different cancer types, including esophageal squamous cell carcinoma, pancreatic adenocarcinoma, biliary tract cancer, non-small cell lung carcinoma, malignant pleural mesothelioma, urothelial cancer, high-grade gliomas, other solid tumors, and lymphomas. During the study, patients will be closely monitored for dose-limiting toxicities and treatment-emergent side effects for up to 52 weeks. Researchers will assess tumor response, disease control, duration of response, progression-free and overall survival, along with pharmacokinetic and pharmacodynamic characteristics of CTS3497 at specific times during treatment cycles. The total observation period may last up to approximately 3 years, ensuring thorough safety and efficacy evaluations.
CONDITIONS
Brief Title
A Phase I/II Clinical Study of CTS3497 in Patients With MTAP Deficient Malignacies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years of age or older at the time of consent.
- Histologically or cytologically confirmed locally advanced or metastatic solid tumors not treatable by surgery and failed standard care, or refractory/relapsed lymphomas.
- Confirmed MTAP deficiency by immunohistochemistry or next-generation sequencing.
- At least one evaluable tumor lesion for dose escalation part; at least one measurable tumor lesion for expansion part.
- ECOG performance status of 0 to 1.
- Adequate bone marrow, heart, liver, kidney, and coagulation function per local laboratory tests.
You will not qualify if you...
- Female patients who are pregnant or breastfeeding.
- Patients with difficulty swallowing or serious gastrointestinal absorption issues.
- Allergies or intolerance to CTS3497 or its components.
- Use of anti-tumor therapy within 28 days before study start.
- Previous treatment with MAT2A or PRMT5 inhibitors.
- Presence of central nervous system metastases at screening.
- Live vaccine within 4 weeks before starting the study drug.
- Use of therapeutic anticoagulation for active blood clots.
- Use of strong CYP3A4 inducers or inhibitors within 14 days or 5 half-lives before study start.
- Unresolved side effects from prior cancer treatments.
- Active infections with HIV, hepatitis B, or hepatitis C.
- Other serious systemic diseases or conditions deemed unsuitable for trial participation by the investigator.
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 - Repeated 21-day cycles up to approximately 48 weeks
Participants receive the study drug CTS3497 orally in cycles to evaluate safety, pharmacokinetics, and anti-tumor activity.
Visits aligned with treatment cycles including assessments on multiple days per cycle
Duration - Up to approximately 3 years
Participants are monitored for safety and overall survival after completing treatment.
Periodic visits for safety and survival assessments
Trial Site Locations
Total: 1 location
1
Beijing Cancer Hospital
Beijing, Beijing Municipality, China, 100142
Actively Recruiting
Research Team
S
Shuning Xing, MS
J
Jifang Gong, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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