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New treatment option for Solid Tumor
Official title A Phase I/II Clinical Study of CTS3497 in Patients With MTAP Deficient Malignacies
ClinicalTrials.gov ID: NCT06971523
What this study is testing
What is CTS3497?
CTS3497 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for solid tumor.
Also referred to as CTS3497 capsules.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- ≥ 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...
- 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...
- ECOG performance status of 0 to 1.
You likely can't join if
- 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.
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.