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Trial Title:
A Study of TY-1091 in Patients With Advanced Solid Tumors
NCT ID:
NCT05675605
Condition:
RET-altered Non Small Cell Lung Cancer
Medullary Thyroid Cancer
RET-altered Papillary Thyroid Cancer
Neoplasms
Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Thyroid Neoplasms
Thyroid Cancer, Papillary
Carcinoma, Neuroendocrine
Thyroid Diseases
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
TY-1091
Description:
TY-1091(10mg,100mg) , once a day, oral administration Dose level is from 20mg to 800mg
Arm group label:
Phase 1 Dose Escalation
Arm group label:
Phase 2 Dose Expansion
Summary:
This is a Phase 1/2, open-label, first-in-human (FIH) study designed to evaluate the
safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary
antineoplastic activity of TY-1091 administered orally in participants with medullary
thyroid cancer (MTC), RET-altered NSCLC and other RET-altered solid tumors.
Detailed description:
The study consists of 2 parts, a dose-escalation part (Phase 1) and an expansion part
(Phase 2). Part1 will enroll participants with advanced non-resectable NSCLC, advanced
non-resectable thyroid cancer and other advanced solid tumors that have progressed
following standard systemic therapy, have not adequately responded to standard systemic
therapy, or the participants must be intolerant to or the Investigator has determined
that treatment with standard therapy is not appropriate, or there must be no accepted
standard therapy for their disease. A multicenter, open-label design is adopted for
part2. According to the obtained data of safety, tolerability, PK characteristics, and
preliminary efficacy of TY-1091, one or two doses will be selected to conduct a dose
expansion trial, which includes 3 cohorts with 20-40 subjects in each cohort.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Diagnosis during dose escalation (Phase 1) - Pathologically documented, definitively
diagnosed non-resectable advanced solid tumor.
All participants treated at doses > 50 mg per day must have MTC, or a RET-altered
solid tumor per assessment of tumor tissue and/or blood
- In the expansion stage phase (Phase 2) , patients should fulfill the following
criteria at Screening Patients with histologically or cytologically confirmed
diagnosis of locally advanced or metastatic NSCLC, MTC, or other solid tumors.
Subject must have a documented RET gene fusion or mutation by a CLIA certified or
equivalent testing. Next-generation sequencing (NGS), quantitative polymerase chain
reaction (qPCR) test or fluorescence in situ hybridization (FISH) can be used to
determine molecular eligibility At least one measurable lesion as defined by RECIST
1.1, not previously irradiated and not chosen for biopsy during the screening
period. Patients without RECIST 1.1 measurable disease will be eligible for
enrollment in Cohort 5.
2. Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2
with no sudden deterioration 2 weeks prior to the first dose of study treatment.
3. Life expectancy of at least 3 months.
4. Adequate organ functions.
5. Ability to swallow capsules and willing and able to provide written informed consent
approved by institutional review board (IRB) or independent ethics committee (IEC).
6. Willingness of men and women of reproductive potential to observe conventional and
effective birth control for the duration of treatment and 6 months following the
last dose of study treatment; this may include barrier methods such as condom or
diaphragm with spermicidal gel.
Exclusion Criteria:
1. For NSCLC patients, a targetable mutation in EGFR or MET, targetable rearrangement
involving ALK, ROS1 or NTRK1-3.
2. History of other previous cancer (except for squamous cell or basal-cell carcinoma
of the skin, or any in situ carcinoma that has been completely resected), requiring
therapy within the previous 5 years.
3. For MTC patients, clinically significant involvement in the trachea, esophagus or
complete encasement of great vessels (e.g., aorta or pulmonary artery) that in the
opinion of the Investigator, could result in life-threatening complications due to
rapid tumor regression.
4. Symptomatic primary central nervous system (CNS) tumor or metastases; symptomatic
leptomeningeal carcinomatosis; untreated spinal cord compression.
5. Cardiovascular and cerebrovascular diseases/symptoms/indications meeting any of the
following conditions:
Mean resting corrected QT interval (electrocardiogram interval measured from the
onset of the QRS complex to the end of the T wave) for heart rate (QTcF) ≥470 msec
obtained from 3 electrocardiograms; Any clinically significant resting ECG
abnormalities in rhythm, conduction, or morphology, such as complete left bundle
branch block, second and third degree heart block, PR interval > 250 ms; Any factors
that increase the risk of QTc prolongation or arrhythmia, such as heart failure,
hypokalemia, congenital long QT syndrome, family history of long QT syndrome, or
unexplained sudden death in a first-degree relative under 40 years of age, or any
concomitant medication known to prolong QT interval; Left ventricular ejection
fraction (LVEF) < 50%; Patients with a previous history of decreased myocardial
contractility who experienced relevant symptoms within 6 months prior to study drug
administration: such as chronic congestive heart failure, pulmonary edema or
decreased cardiac ejection fraction; Patients with a history of acute or chronic
cardiovascular and cerebrovascular diseases who had relevant symptoms within 6
months prior to study drug administration: such as myocardial infarction, severe or
unstable angina, cerebral infarction, cerebral hemorrhage or transient ischemic
attack.
6. Patients who have received treatment within 14 days prior to the first dose or need
to continue treatment with strong CYP3A4 inducers/strong inhibitors,
CYP3A4/CYP2C9/CYP2C19 sensitive substrate with a narrow treatment window or strong
p-glycoprotein inhibitors.
7. Systemic anti-tumor treatment such as standard chemotherapy, biological therapy and
immunological drug therapy within 28 days prior to the first dose; targeted therapy
within 14 days or 5 half-lives of the first dose (calculated as a long time);
anti-tumor traditional Chinese traditional medicine treatment within 7 days prior to
the first dose.
Gender:
All
Minimum age:
18 Years
Maximum age:
100 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Jinlin Province Cancer Hosipital
Address:
City:
Chang chun
Zip:
130000
Country:
China
Status:
Recruiting
Contact:
Last name:
Ying Cheng, Bachelor
Phone:
15044044052
Email:
1165095416@qq.com
Start date:
April 24, 2023
Completion date:
December 1, 2025
Lead sponsor:
Agency:
TYK Medicines, Inc
Agency class:
Industry
Source:
TYK Medicines, Inc
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05675605