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New treatment option for Locally Advanced or Metastatic Solid Tumors
Official title A Study of TYK-00540 in Adult Patients With Solid Tumors
ClinicalTrials.gov ID: NCT06246071
What this study is testing
What is TYK-00540?
TYK-00540 is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for locally advanced or metastatic solid tumors.
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 this study is to evaluate the safety and tolerability of TYK-00540, with dose-escalation stage and dose-expansion stage.
- Phase 1: an early, usually small safety study
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. Healthy volunteers may be eligible.
You may be able to join if
- Age ≥18 years.
- In the Single-agent escalation phase, people should fulfill the following criterion at Screening: Histologically or cytologically confirmed locally...
- Any prior treatment can be considered as one of the SOC regimens if executed on patients with the receptor status of triple-negative no matter the...
- For patients whose treatment have been changed due to intolerability to toxicity, the intolerable regimens can be included as one of the prior...
- For neoadjuvant and/or adjuvant chemotherapy, if relapse or disease progression to locally advanced or metastatic disease occurs during treatment or...
You likely can't join if
- Known allergy to any excipients of TYK-00540 tablets (for combination-agent escalation phase and combination expansion phase, known contraindications...
- people with prior therapy of: Systemic anti-tumor treatment such as standard chemotherapy, macromolecular targeted drugs and immunological drug...
- people with other malignancies or a history of other malignant tumors, except for cured basal cell carcinoma of the skin or squamous cell carcinoma...
- Any unresolved toxicities from prior therapy greater than NCI CTCAE Grade 1 at the time of starting study treatment with the exception of Grade 2...
- Patients with primary central nervous system (CNS) tumors or CNS metastases that have failed local therapy. Patients who are asymptomatic or...
- The subject has symptoms of spinal cord compression due to the tumor.
See the full eligibility criteria
Who can join
- Age ≥18 years.
- In the Single-agent escalation phase, people should fulfill the following criterion at Screening: Histologically or cytologically confirmed locally advanced/metastatic solid tumors that do not have, failed or...
- Any prior treatment can be considered as one of the SOC regimens if executed on patients with the receptor status of triple-negative no matter the previous pathological type;
- For patients whose treatment have been changed due to intolerability to toxicity, the intolerable regimens can be included as one of the prior standards of care regimens;
- For neoadjuvant and/or adjuvant chemotherapy, if relapse or disease progression to locally advanced or metastatic disease occurs during treatment or within 12 months after discontinuation of treatment (at least 2 cycles...
- For patients with documented germline BRCA1/BRCA2 mutations, if they have been treated with an approved PARP inhibitor, then the PARP inhibitor can be considered as one of the 2 lines of prior SOC regimens required. In...
- people in the escalation phase should have measurable or evaluable lesions at baseline; Measurable lesions required in the expansion phase (RECIST 1.1).
- ECOG performance status is 0 to 1 and there is no deterioration in the 2 weeks prior to the first dose.
- Life expectancy of at least 3 months.
- Adequate organ functions, defined as: ALT or AST ≤ 2.5×the upper limit of normal (ULN) or ≤ 5 ×ULN with documented liver involvement (such as liver metastasis or a primary biliary tumor) and Total bilirubin ≤ 1.5 ×ULN...
- Willing and able to provide written informed consent approved by institutional review board (IRB) or independent ethics committee (IEC).
- Willingness of men and women of reproductive potential to observe conventional and effective birth control for the duration of treatment and 6 months following the last dose of study treatment; this may include barrier...
What rules you out
- Known allergy to any excipients of TYK-00540 tablets (for combination-agent escalation phase and combination expansion phase, known contraindications to fulvestrant should also be considered).
- people with prior therapy of: Systemic anti-tumor treatment such as standard chemotherapy, macromolecular targeted drugs and immunological drug therapy within 28 days prior to the first dose; reception of endocrine...
- people with other malignancies or a history of other malignant tumors, except for cured basal cell carcinoma of the skin or squamous cell carcinoma, carcinoma in situ of the cervix, papillary thyroid cancer, carcinoma...
- Any unresolved toxicities from prior therapy greater than NCI CTCAE Grade 1 at the time of starting study treatment with the exception of Grade 2 alopecia and prior platinum-therapy related neuropathy.
- Patients with primary central nervous system (CNS) tumors or CNS metastases that have failed local therapy. Patients who are asymptomatic or clinically stable and do not require steroids and other treatments for CNS...
- The subject has symptoms of spinal cord compression due to the tumor.
- Uncontrollable or poorly controlled effusion of chest, abdomen, pelvis, or pericardium.
- Any baseline 12-lead ECG abnormalities which may impair the safety of people (such as baseline QTc interval ≥ 470 msec, complete left bundle branch block (LBBB), acute or unspecified myocardial infarction, active...
- Have had any of the following in the past 6 months: myocardial infarction, long QT syndrome, torsades de pointes, arrhythmias (double-bundle branch block, such as right bundle branch block (RBBB) with left anterior or...
- people with any other disease or medical condition that is unstable or could affect their safety or study compliance, any serious or uncontrolled systemic disease, including uncontrolled hypertension (systolic blood...
- Known active infections, including human immunodeficiency virus (HIV), hepatitis B virus (HBV), and hepatitis C virus (HCV) infection, except for asymptomatic chronic HBV or HCV carriers. Active HBV, HCV, or HIV...
- Hepatitis B surface antigen (HBsAg) positive and HBV-DNA ≥ 2000 cps/mL or 500 IU/mL; HBsAg-negative, anti-HBc-positive patients are at high risk of HBV reactivation who require suppressive antiviral therapy prior to...
- Anti-HCV antibody positive and HCV-RNA \> upper normal limit defined by sites;
- Anti-HIV antibody positive with uncontrolled opportunistic infections; anti-HIV antibody positive with CD4+ count\< 350 cells/uL that requires HIV therapy prior to the cancer treatment; other conditions allowing...
- History of positively diagnosed interstitial lung disease or interstitial pneumonia (ILD), drug-induced ILD, or radiation pneumonitis requiring hormone therapy, or any evidence of active ILD (e.g., acute onset or...
- Clinically significant gastrointestinal abnormalities at screening that may affect the intake, transport or absorption of drugs (such as dysphagia, uncontrollable nausea and vomiting, active gastric ulcer, ulcerative...
- Clinically significant hypercoagulability.
- Pregnant and lactating women.
- people who, in the opinion of the investigator, would not be suitable for participation in this study (e.g., not in line with the treatment of the subject's best benefit, subject compliance, etc.).
The study team makes the final eligibility decision.
Where it's taking place
- Hefei, 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. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hefei, 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.