Study of TYK-01054 Capsules in Patients With Advanced Solid Tumors
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorTYK Medicines, Inc
About this trial
This study is to evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of the TEAD inhibitor TYK-01054 capsules in patients with locally advanced or metastatic advanced solid tumors
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male or female subjects ≥18 years old
Histologically or cytologically confirmed incurable, locally advanced or metastatic advanced solid tumors. All participants are required to provide results of Hippo signaling pathway gene testing; however, this requirement is not a mandatory inclusion criterion for Dose Escalation (Part A) and EHE patients.
Advanced solid tumors must have progressed after receiving at least one standard first-line anti-tumor therapy, OR demonstrate intolerance to standard therapy, OR Lack of standard treatment.
Patients should have at least 1 measurable lesion as per RECIST v1.1 or mRECIST v1.1.
Disqualifiers
Presence of pleural effusion, pericardial effusion, or ascites that, in the investigator's judgment, cannot be stably controlled by repeated drainage or other methods.
Clinically significant renal disease.
Clinically significant cardiovascular disease, including but not limited to myocardial infarction, unstable angina, congestive heart failure (NYHA Class ≥ II), or uncontrolled arrhythmias.
Patients with uncontrolled infectious diseases, such as immunodeficiency disorders (e.g., HIV) or active hepatitis B or C infection; chronic hepatitis B or C carriers without symptoms are excluded from this criterion.
Trial design
Design model
Single group
Treatments tested in this trial
TYK-01054
DrugTKY-01054 will be administered orally at a starting dose of 25 mg in 21-day cycles. If well tolerated, dose expansion will proceed in the recommended dose for expansion (RDE) and RDE-1 until the recommended Phase II dose (RP2D) is determined.
Treatment groups
219 Participants
are divided into 1 treatment groupGroup A: TKY-01054Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Dose Limiting Toxicity
Numbers of participants experiencing AEs which are defined as DLTs classfied by CTCAE v6.0
Time frame
Up to approximately 28 days2
Maximum tolerated dose（MTD）
The maximum dose when DLT% ≤ 33% during the DLT observation period
Time frame
Through the Dose Escalation phase, approximately 12 months3
Number of participants who experience one or more adverse events (AEs)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Time frame
From Baseline up to 28 days after the end of the treatment4
Recommended Dose for Expansion(RDE)
Recommended Dose for Expansion
Time frame
Through the Dose Escalation Phase, approximately 24 monthsSecondary outcomes
1
Evaluate the pharmacokinetics of TYK-01054
Based on the plasma concentration ofTYK-01054
Time frame
Through the Dose Escalation stage and Dose Optimization stage, approximately 24 month2
Evaluate the effectiveness of TYK-01054
Efficacy evaluation will be determined by RECIST v1.1 or modified RECIST v1.1
Time frame
Approximately 36 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: