Testing CTS3497 for patients with specific cancer types

A Multi-center, Open-label, Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumor Activity of CTS3497 in Patients With MTAP Deficient Advanced Solid Tumors and Lymphomas

This study is testing a new drug called CTS3497 to see if it can help patients with certain hard-to-treat cancers that have not responded to other treatments.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 224 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: CytosinLab Therapeutics Co., Ltd. (Industry-sponsored)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT06971523 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults with confirmed MTAP-deficient solid tumors or lymphomas that are advanced and have not responded to standard treatments.

Not a fit: Patients with tumors that are not MTAP-deficient or those who are currently pregnant or lactating may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with MTAP-deficient malignancies.

How similar studies have performed: While this approach is novel in targeting MTAP-deficient tumors, similar studies targeting specific genetic deficiencies have shown promise in other contexts.

Eligibility criteria

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 this trial is running

Beijing, Beijing Municipality

• Beijing Cancer Hospital — Beijing, Beijing Municipality, China (Recruiting)

Study contacts

• Study coordinator: Shuning Xing, MS

Conditions Solid Tumor; Lymphoma; PRMT5