Status:
RECRUITING
A Phase I/II Clinical Study of CTS3497 in Patients With MTAP Deficient Malignacies
Lead Sponsor:
CytosinLab Therapeutics Co., Ltd.
Conditions:
Solid Tumor
Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
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 w...
Detailed Description
The primary objective of Phase I of this study is to evaluate the safety, tolerability, PK, PD and efficacy to determine the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) of CTS3497 ...
Eligibility Criteria
Inclusion
- ≥ 18 years of age at the signing of ICF.
- Patients with histologically or cytologically confirmed locally advanced or metastatic solid tumors who cannot be treated surgically and have failed standard of care (SoC). Or patients with refractory/relapsed lymphomas.
- MTAP deficiency is confirmed by IHC or NGS.
- At least one evaluable tumor lesion at screening for patients in escalation part, and at least one measurable tumor lesion for patients in expansion part.
- ECOG performance status of 0 to 1.
- Adequate hematopoietic function, cardiac function, liver function, renal function, and coagulation function per local laboratory.
Exclusion
- Female patients in pregnancy or lactation.
- Patients with dysphagia; or a condition that seriously affects gastrointestinal absorption.
- Allergic or intolerant to the active ingredients or excipients of the investigational product.
- Anti-tumor therapy within 28 days of study day 1.
- Prior treatment with an methionine adenosyltransferase 2α (MAT2A) inhibitor or a protein arginine methyltransferase 5 (PRMT5) inhibitor.
- Central nervous system (CNS) metastasis at screening.
- Live vaccine therapy within 4 weeks before study drug administration.
- Use of therapeutic anti-coagulation for treatment of active thromboembolic events.
- Use of prescription medications that are known strong inducers or inhibitors of cytochrome P450 3A4 (CYP3A4) within 14 days or 5 half-lives (whichever is longer) before study day 1.
- Unresolved toxicity from prior anti-cancer therapy.
- Active infection of HIV, HBV or HCV.
- 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.
Key Trial Info
Start Date :
December 25 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2029
Estimated Enrollment :
224 Patients enrolled
Trial Details
Trial ID
NCT06971523
Start Date
December 25 2024
End Date
June 30 2029
Last Update
May 14 2025
Active Locations (1)
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1
Beijing Cancer Hospital
Beijing, Beijing Municipality, China, 100142