A Study of TY-2699a in Patients With Locally Advanced or Metastatic Solid Tumors
ConditionSolid Tumor, Adult
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorTYK Medicines, Inc
About this trial
This is a phase I, multicenter, open-label study. The study will investigate the safety, tolerability, PK, and preliminary efficacy of TY-2699a on locally advanced or metastatic solid tumors.
Eligibility criteria
Qualifiers
Be able to provide written informed consent approved by institutional review board (IRB) or independent ethics committee (IEC).
Age ≥18 years.
No blood transfusion, blood products, or hematopoietic factors such as G-CSF, erythropoietin or albumin within 14 days prior to first dose.
Cockcroft-Gault Equation. 10. For female patients of childbearing potential, the serum or urine pregnancy test within 7 days prior to the start of TY-2699a treatment should be negative.
Disqualifiers
Concurrent participation in another interventional clinical trial, unless the patient at long-term follow-up period.
Received undergone major surgery (except minor surgery such as appendicitis, tumor biopsy, etc.) within 4 weeks prior to the first dose.
Received bone marrow (equal to area of pelvis) or extensive radiation therapy within 28 days prior to the first dose; received local radiation therapy (e.g., thoracic spine and rib radiation therapy) within 7 days prior to the first dose of the study drug.
Received CYP3A and CYP2C8 strong inducers/strong inhibitors or p-gp glycoprotein inhibitors within 14 days prior to the first dose (see Appendices 15.3 Examples of CYP450-related Drugs/food).
Trial design
Treatments tested in this trial
- TY-2699a
Treatment groups
156 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov