A Phase I/II Clinical Study of CTS3497 in Patients With MTAP Deficient Malignacies
NCT ID: NCT06971523
Last Updated: 2025-05-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
224 participants
INTERVENTIONAL
2024-12-25
2029-06-30
Brief Summary
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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.
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Detailed Description
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The primary objective of Phase II of this study is to evaluate the efficacy and safety of CTS3497 in patients with metastatic or locally advanced MTAP-deficient solid tumors and lymphomas.
Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Phase I: CTS3497 Monotherapy Dose Escalation/Dose Expansion
7 dose groups are pre-specified in Dose Escalation,and 2-3 dose groups in Dose Expansion.
CTS3497
CTS3497: Orally via capsules
Phase II: CTS3497 Monotherapy Expansion
CTS3497 RP2D administered to patients with MTAP homozygous deletion including the following cohorts: esophageal squamous cell carcinoma \[ESCC\], pancreatic adenocarcinoma \[PAAD\], biliary tract cancer \[BTC\], non-small cell lung carcinoma\[NSCLC\], malignant pleural mesothelioma \[MPM\], Urothelial cancer, high-grade gliomas, other solid tumors, and lymphomas.
CTS3497
CTS3497: Orally via capsules
Interventions
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CTS3497
CTS3497: Orally via capsules
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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.
18 Years
ALL
No
Sponsors
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CytosinLab Therapeutics Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Haiping Wu, PhD
Role: STUDY_CHAIR
CytosinLab Therapeutics Co., Ltd.
Locations
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Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CTS3497-CI01
Identifier Type: -
Identifier Source: org_study_id
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