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
This trial does not accept healthy volunteersQualifiers
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
Design model
Sequential
Treatments tested in this trial
TY-2699a
DrugTY-2699a PO, BID Escalation stage: increased dose cohorts from low dose to MTD Expansion stage: The dose for the Expansion stage will be determined based on results
Treatment groups
156 Participants
are divided into 1 treatment groupGroup A: TY-2699aExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Escalation stage) Dose Limiting Toxicities (DLTs)
Numbers of participants experiencing AEs which are defined as DLTs classfied by CTCAE v5.0.
Time frame
Within 28 days of the first dose2
(Escalation stage) Recommended Phase 2 Dose (RP2D)
The RP2D is defined as the dose level chosen for the dose expansion arms, based on safety, tolerability, efficacy, pharmacokinetics (PK), and pharmacodynamic (PD) data collected during the dose escalation portion of the study.
Time frame
Within 28 days of the last patient dosed in escalation stage3
(Escalation stage) 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
(Expansion stage) Overall Response Rate (ORR)
ORR is defined as the percentage of subjects who have a partial response (PR) or complete response (CR) to the treatment response assessment in accordance to Response Evaluation Criteria in Solid Tumors (RECIST 1.1).
Time frame
From the date of first dose until the date of first documented progression or stable disease or the date of death from any cause, whichever came first, assessed up to 30 months.Secondary outcomes
1
(Escalation and Expansion stage) Area under the plasma concentration time curve(AUC0-inf)
AUC0-inf defined as the area under the plasma concentration-time curve from time 0 extrapolated to Infinite time.
Time frame
Cycle 1 Day 1 (at pre-dose) and Cycle 1 Day 28 (at pre-dose, 0.5, 1, 2, 4, 8, 12 hours post-dose)(Each Cycle=28 days)2
(Escalation and Expansion stage) Area under the plasma concentration time curve(AUC0-t)
AUC0-t defined as area under the plasma concentration-time curve from time 0 to time t.
Time frame
Cycle 1 Day 1 (at pre-dose) and Cycle 1 Day 28 (at pre-dose, 0.5, 1, 2, 4, 8, 12 hours post-dose)(Each Cycle=28 days)3
(Escalation and Expansion stage) 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
Cycle 1 Day 1 (at pre-dose) and Cycle 1 Day 28 (at pre-dose, 0.5, 1, 2, 4, 8, 12 hours post-dose)(Each Cycle=28 days)4
(Escalation and Expansion stage) Minimum plasma concentration (Cmin)
Cmin is the minimum plasma concentration that the drug achieves in blood after the drug has been administered.
Time frame
Cycle 1 Day 1 (at pre-dose) and Cycle 1 Day 28 (at pre-dose, 0.5, 1, 2, 4, 8, 12 hours post-dose)(Each Cycle=28 days)Sponsors and contacts
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Source ClinicalTrials.gov