Actively Recruiting
A Phase I/II Clinical Study of CTS3497 in Patients With MTAP Deficient Malignacies
Led by CytosinLab Therapeutics Co., Ltd. · Updated on 2025-05-14
224
Participants Needed
1
Research Sites
235 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The primary objective of Phase I of this study is to evaluate the safety and tolerability, and to determine the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) of CTS3497 in patients with metastatic or locally advanced methylthioadenosine phosphorylase (MTAP)-deficient solid tumors and lymphomas. The primary objective of Phase II of this study is to evaluate the efficacy of CTS3497 in patients with metastatic or locally advanced MTAP-deficient solid tumors and lymphomas.
CONDITIONS
Official 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 signing informed consent
- Histologically or cytologically confirmed locally advanced or metastatic solid tumors not treatable by surgery and failed standard of care, or refractory/relapsed lymphomas
- Confirmed MTAP deficiency by immunohistochemistry or next-generation sequencing
- At least one evaluable tumor lesion for dose escalation or one measurable tumor lesion for dose expansion
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate blood, heart, liver, kidney, and coagulation functions based on local laboratory tests
You will not qualify if you...
- Female patients who are pregnant or breastfeeding
- Patients with swallowing difficulties or conditions seriously affecting gastrointestinal absorption
- Allergy or intolerance to CTS3497 ingredients or excipients
- Anti-tumor therapy received within 28 days before study start
- Prior treatment with MAT2A or PRMT5 inhibitors
- Presence of central nervous system metastasis at screening
- Live vaccine therapy within 4 weeks before starting study drug
- Use of therapeutic anticoagulation for active thromboembolic events
- Use of strong CYP3A4 inducers or inhibitors within 14 days or 5 half-lives before study start
- Unresolved toxicity from previous anti-cancer therapy
- Active infections of HIV, hepatitis B, or hepatitis C
- Other serious systemic diseases or conditions making participation unsuitable as judged by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Beijing Cancer Hospital
Beijing, Beijing Municipality, China, 100142
Actively Recruiting
Research Team
S
Shuning Xing, MS
CONTACT
J
Jifang Gong, MD
CONTACT
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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