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Recruiting NCT06971523

A Phase I/II Clinical Study of CTS3497 in Patients With MTAP Deficient Malignacies

Phase I / Phase II Interventional Solid Tumor Lymphoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: CTS3497.
Who it may be relevant to
Registry conditions: Solid Tumor, Lymphoma. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

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 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 and safety of CTS3497 in patients with metastatic or locally advanced MTAP-deficient solid tumors and lymphomas.

Interventions

  • Drug CTS3497
    CTS3497: Orally via capsules

Primary outcome measures

  • Phase I: Number of Patients Who Experience a Dose-Limiting Toxicity (DLT) [Time frame: Up to 21 days after the first administration.]
  • Phase I: Number of Patients Who Experience a Treatment-emergent Adverse Event (TEAE) [Time frame: Baseline through 28 days after the end of treatment, estimated up to 52 weeks.]
  • Phase II: Objective Response Rate (ORR) [Time frame: up to 48 weeks.]
Secondary outcome measures (9)
  • Cmax of CTS3497 [Time frame: Cycle 1 (each cycle is 21 days) Day 1, Cycle 1 Day 8, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 3 Day 1, Cycle 5 Day 1]
  • Tmax of CTS3497 [Time frame: Cycle 1 (each cycle is 21 days) Day 1, Cycle 1 Day 8, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 3 Day 1, Cycle 5 Day 1]
  • AUC of CTS3497 [Time frame: Cycle 1 (each cycle is 21 days) Day 1, Cycle 1 Day 8, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 3 Day 1, Cycle 5 Day 1]
  • Disease control rate (DCR) [Time frame: up to 48 weeks.]
  • Duration of Response (DoR) [Time frame: Estimated up to 48 weeks.]
  • Progression-Free Survival (PFS) [Time frame: Estimated up to 48 weeks.]
  • Overall Survival (OS) [Time frame: Up to approximately 3 years.]
  • Pharmacodynamic (PD) characteristics of CTS3497: symmetric dimethylarginine (SDMA) [Time frame: Cycle 1 (each cycle is 21 days) Day 1, Cycle 1 Day 8, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 3 Day 1, Cycle 5 Day 1 and Cycle 7 Day 1]
  • Pharmacodynamic (PD) characteristics and efficacy analysis. [Time frame: Estimated up to 48 weeks.]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Beijing Cancer Hospital — Beijing

Identifiers

NCT: NCT06971523 · CTS3497-CI01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗