Testing CTS3497 for patients with specific cancer types

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the safety, tolerability, and efficacy of CTS3497 in patients with metastatic or locally advanced solid tumors and lymphomas that are deficient in methylthioadenosine phosphorylase (MTAP). The study is divided into two phases: Phase I focuses on determining the maximum tolerated dose (MTD) and assessing safety, while Phase II aims to evaluate the drug's efficacy. Patients must have tumors that cannot be surgically removed and have failed standard treatments. The trial is conducted at Beijing Cancer Hospital.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* ≥ 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 Criteria:

* 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.

Where it's running

• Beijing Cancer Hospital
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Study coordinator: Shuning Xing, MS
• Email: shuning.xing@cytosinlab.com
• Phone: 0086-21-58920766

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.