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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 30 months after the date of first dose.
Awards & highlights
Study Summary
This trial tests a new drug to see if it's safe and effective, with different doses to determine the right one.
Who is the study for?
Adults with advanced solid tumors and specific genetic changes (ALK, ROS1, NTRK1-3) who've tried standard treatments without success or can't tolerate them. They must be able to swallow tablets, have a life expectancy of at least 3 months, use effective contraception if of childbearing potential, and not have symptomatic brain metastases or certain lung diseases.Check my eligibility
What is being tested?
The trial is testing the safety and ideal dosage of TY-2136b in two stages: dose escalation to find the safe maximum dose and dose expansion to study its effects more broadly. Participants will take TY-2136b to see how it affects their tumors.See study design
What are the potential side effects?
Specific side effects for TY-2136b are not listed but generally may include typical reactions like nausea, fatigue, risk of infection due to immune system impact, allergic reactions or organ-specific inflammation similar to other cancer drugs.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 30 months after the date of first dose.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 30 months after the date of first dose.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
(Escalation stage) Adverse events (AEs)
(Escalation stage) Dose Limiting Toxicities (DLTs)
(Escalation stage) Recommended Phase 2 Dose (RP2D)
+1 moreSecondary outcome measures
(Escalation and Expansion stage) Area under the plasma concentration time curve(AUC0-inf)
(Escalation and Expansion stage) Area under the plasma concentration time curve(AUC0-t)
(Escalation and Expansion stage) Duration of Response (DOR)
+7 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Expansion stageExperimental Treatment1 Intervention
Expansion stage: 4 distinct expansion cohorts
Group II: Escalation stageExperimental Treatment1 Intervention
Escalation stage: Multiple doses of TY-2136b for oral administration to find the maximum tolerated dose
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Who is running the clinical trial?
TYK Medicines, IncLead Sponsor
11 Previous Clinical Trials
1,959 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had serious heart problems in the last 6 months.I am 18 years old or older.I haven't had major surgery in the last 4 weeks or radiation therapy in the last 2 weeks.I have a digestive system condition that affects food absorption.I have used acid reflux medication recently.I have had chemotherapy or immunotherapy for cancer before.I am willing and able to sign a consent form approved by an ethics committee.I have a history of severe lung scarring or lung disease.I agree to use two effective birth control methods if I can have children.I have not taken strong drugs that affect liver enzymes or certain drug transporters recently.I am fully active or can carry out light work.I have tried standard cancer treatments without success or couldn't tolerate them.I have brain metastases but no symptoms.I do not have active infections like HIV, hepatitis B, or hepatitis C.I can swallow pills whole without chewing or opening them.My cancer is advanced or has spread, and tests show specific genetic changes.I do not have moderate or severe numbness, tingling, or pain in my hands or feet.I have recovered from the side effects of my previous cancer treatments.I have risk factors for abnormal heart rhythms.I have brain metastases or cancer in the lining of my brain and spinal cord that cause symptoms.I have been treated for another cancer within the last 2 years.My cancer is advanced or has spread, and tests show specific genetic changes.I am on long-term medication to suppress my immune system.
Research Study Groups:
This trial has the following groups:- Group 1: Escalation stage
- Group 2: Expansion stage
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What precautions should be taken to ensure safety during the Escalation stage?
"The safety of the Escalation stage has been rated a 1 as it is currently in Phase 1, meaning there are only limited data available on both efficacy and security."
Answered by AI
What are the fundamental aims of this experiment?
"Within four weeks of the initial dose, this trial will assess a Recommended Phase 2 Dose (RP2D). Secondary measurements include Area under Plasma Concentration Time Curve (AUC0-t), Maximum Plasma Concentration (Cmax), and Minimum Plasma Concentration (Cmin)."
Answered by AI
Does this experiment currently have open enrollment?
"Data posted to clinicaltrials.gov reveals that this trial, which was first published on March 1st 2023, is not currently recruiting new participants despite having last been updated two days prior. Despite the setback, there are still 2440 other trials actively seeking patients."
Answered by AI
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