A Study of TYK-00540 in Adult Patients With Solid Tumors
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorTYK Medicines, Inc
About this trial
The primary objective of this study is to evaluate the safety and tolerability of TYK-00540, with dose-escalation stage and dose-expansion stage.
Eligibility criteria
Qualifiers
Age ≥18 years.
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 have been completed), it will be considered as one of the SOC regimens;
Disqualifiers
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).
Subjects 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 therapy, small molecule targeted drugs and oral fluorouracil within 14 days before the first dose; reception of nitrosoureas and mitomycin within 6 weeks prior to the first dose Major surgery (except minor surgeries such as appendicitis and tumor biopsy) within 4 weeks prior to the planned start of TYK-00540. Subjects who have taken proton pump inhibitors (PPIs) within 7 days prior to the first dose of TYK-00540, or require continuation of therapy during the study. Subjects who were receiving and need to continue treatment with medications known to prolong the QTc interval or potentially cause Torsade de pointe ventricular tachycardia during the treatment. Participation in other clinical trials (excluding non-interventional drug clinical trials) within 28 days prior to the first dose; Prior allogeneic bone marrow transplantation.
Subjects 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 in situ of the breast duct, or other malignant tumors that have survived for more than 5 years.
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.
Trial design
Treatments tested in this trial
- TYK-00540
Treatment groups
156 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov