Actively Recruiting
A Phase Ia/Ib, Multicenter, Open-label Study of TYK-00540 Administered Orally in Adults With Locally Advanced or Metastatic Solid Tumors
Led by TYK Medicines, Inc · Updated on 2024-02-07
156
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying TYK-00540 in adult patients with locally advanced or metastatic solid tumors to assess its safety and tolerability. The trial aims to identify dose-limiting toxicities and determine the maximum tolerated dose. Additionally, the study investigates how the drug and its metabolites behave in the body after single and multiple oral doses, while also assessing early signs of effectiveness. The study has two main parts: a dose-escalation stage and a dose-expansion stage. During the escalation phase, participants receive multiple oral doses of TYK-00540 tablets twice daily every 28 days to find the maximum tolerated dose. In the expansion phase, an optimal dose identified from the first stage is given twice daily in 28-day cycles to further evaluate safety and effects. Participants will undergo regular assessments including monitoring for dose-limiting toxicities within the first 31 days, tracking adverse events throughout treatment and for 28 days after, and measuring tumor response over at least 24 weeks. Blood samples will be collected at various times to study drug levels in the body. Safety will be closely monitored, and the study is expected to continue until December 2026.
CONDITIONS
Brief Title
A Study of TYK-00540 in Adult Patients With Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Histologically or cytologically confirmed locally advanced or metastatic solid tumors without standard of care or who have failed or are intolerant to standard of care
- For expansion phase cohorts: specific tumor types including platinum-resistant high-grade serous ovarian cancer, triple-negative breast cancer with prior treatments, or ER+/HER2- breast cancer after CDK4/6 inhibitor therapy
- Measurable or evaluable lesions at baseline
- ECOG performance status of 0 to 1 with no recent deterioration
- Life expectancy of at least 3 months
- Adequate organ function including liver, kidney, heart, blood counts, and coagulation
- Ability and willingness to provide written informed consent
- Agreement to use effective birth control during treatment and for 6 months after last dose
You will not qualify if you...
- Allergy to TYK-00540 tablets or fulvestrant (if applicable)
- Recent systemic anti-tumor treatments or major surgery within specified time frames
- Use of proton pump inhibitors within 7 days prior to dosing or need to continue them during study
- Use of medications that prolong QTc interval or risk arrhythmia
- Participation in other clinical trials within 28 days prior to dosing
- Prior allogeneic bone marrow transplantation
- Other active malignancies or recent history of certain cancers
- Unresolved toxicities from prior therapies above grade 1 except specific exceptions
- Primary CNS tumors or active CNS metastases unless stable and asymptomatic
- Symptoms of spinal cord compression
- Uncontrolled effusions in chest, abdomen, pelvis, or pericardium
- Significant ECG abnormalities affecting safety
- Recent serious cardiac or thromboembolic events
- Any unstable or serious systemic diseases including uncontrolled hypertension or diabetes
- Active infections including HIV, hepatitis B or C with specific criteria
- History or risk of interstitial lung disease or pneumonitis
- Significant gastrointestinal disorders affecting drug absorption
- Clinically significant hypercoagulability
- Pregnant or breastfeeding women
- Any condition that may affect safety or study compliance as judged by investigator
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
screening and enrollment visit
Duration - Repeated 28-day cycles until disease progression or discontinuation
Participants receive multiple doses of TYK-00540 tablets orally twice daily in 28-day cycles to evaluate dose limiting toxicities and determine the maximum tolerated dose.
Visits occur regularly for dosing and safety assessments during each 28-day cycle
Duration - Up to 28 days after treatment ends
Participants are monitored for adverse events and treatment effects up to 28 days after the end of treatment.
Approximately 1 follow-up visit
Trial Site Locations
Total: 1 location
1
Anhui Provincial Hospital
Hefei, China
Actively Recruiting
Research Team
J
Jian Zhang, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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