RecruitingPhase 1Phase 2NCT06950086

Study of TYK-00540 Tablets in Patients With Advanced Solid Tumors

A Phase I/II Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of the CDK2/4/6 Inhibitor TYK-00540 Tablets in Patients With Advanced Solid Tumors


Sponsor

TYK Medicines, Inc

Enrollment

180 participants

Start Date

Jan 2, 2024

Study Type

INTERVENTIONAL

Summary

This study is to evaluate the safety, pharmacokinetics, and preliminary antitumor activity of TYK-00540 as monotherapy or combined with fulvestrant in advanced solid tumors.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new tablet medication called TYK-00540 in patients with advanced solid tumors (cancers that form masses in the body). The study is evaluating safety, dosing, and effectiveness across several cancer types, including ovarian cancer, breast cancer, and others. **You may be eligible if...** - You are 18 years or older - You have a confirmed advanced or metastatic solid tumor with no remaining standard treatment options, or you have refused standard treatment - For specific cohorts: certain cancer types may be required (such as platinum-resistant ovarian cancer or specific breast cancer subtypes) - You are in relatively good physical condition (ECOG score 0-1) **You may NOT be eligible if...** - You have already received certain prior treatments that overlap with this drug's mechanism - You have significant heart, liver, or kidney problems - You are pregnant or breastfeeding - You have brain metastases that are not stable Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTYK-00540

Increased dose cohorts from low to MTD (5mg Cohort 1;10 mg Cohort 2; 20 mg Cohort 3; 30 mg Cohort 4;40 mg Cohort 5) decreased dose cohorts for the combination (TYK-00540 30 mg+Fulvestrant Cohort 1;TYK-00540 20mg +Fulvestrant)


Locations(2)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

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NCT06950086