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
This trial accepts healthy volunteersQualifiers
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
Design model
Sequential
Treatments tested in this trial
TYK-00540
DrugTYK-00540 PO, BID
Treatment groups
156 Participants
are divided into 1 treatment groupGroup A: TYK-00540Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Dose Limiting Toxicity (DLT)
Numbers of participants experiencing AEs which are defined as DLTs classfied by CTCAE
Time frame
Within 31 days of the first dose2
Recommended dose for combination-agent escalation and single-agent expansion (RDE)
To determine the recommended dose for combination-agent escalation and single-agent expansion agent expansion.
Time frame
1 year3
Adverse events (AEs)
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0.
Time frame
From Baseline up to 28 days after the end of the treatment4
Objective response rate (ORR)
ORR is defined as the proportion of patients with a best overall response of complete response (CR) or partial response (PR) assessment in accordance to Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
Time frame
At least 24 weeksSecondary outcomes
1
The time to the peak concentration (Tmax)
Tmax is defined as the time of maximum concentration of the drug in blood observed after a drug dose administration.
Time frame
0 hours (h) (within 30 min before dosing), 0.25 h, 0.5 h , 1 h , 2 h , 3 h, 4 h, 8 h , 12 h, 24 h after dosing2
Maximum plasma concentration (Cmax)
Cmax is the maximum (or peak) plasma concentration that the drug achieves in blood after the drug has been administered.
Time frame
0 hours (h) (within 30 min before dosing), 0.25 h, 0.5 h , 1 h , 2 h , 3 h, 4 h, 8 h , 12 h, 24 h after dosing3
Minimum plasma concentration (Cmin)
Cmin is the minimum plasma concentration that the drug achieves in blood after the drug has been administered.
Time frame
0 hours (h) (within 30 min before dosing), 0.25 h, 0.5 h , 1 h , 2 h , 3 h, 4 h, 8 h , 12 h, 24 h after dosing4
Area under the plasma concentration time
AUC0-inf defined as the area under the plasma concentration-time curve from time 0 extrapolated to Infinite time.
Time frame
0 hours (h) (within 30 min before dosing), 0.25 h, 0.5 h , 1 h , 2 h , 3 h, 4 h, 8 h , 12 h, 24 h after dosingSponsors and contacts
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Source ClinicalTrials.gov