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Oral TACH101 for Cancer
Phase 1
Waitlist Available
Research Sponsored by Tachyon Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1
Participant must be 18 years of age or older
Must not have
Significant cardiovascular disease including myocardial infarction, uncontrolled angina, congestive heart failure, prolonged QT interval, significant ventricular arrhythmias, heart block, uncontrolled hypertension
Any ongoing anticancer therapy, clinically significant active infections, history of HIV, hepatitis B, or hepatitis C
Timeline
Screening 3 weeks
Treatment Varies
Follow Up lead-in day 1 to end of treatment (up to approximately 204 days)
Awards & highlights
Summary
This trial is testing a new oral medication called TACH101 in patients with advanced and metastatic solid tumors. Researchers aim to find the best dose that patients can handle and see if it can shrink or stop the tumors. They are also checking how safe the medication is for these patients.
Who is the study for?
This trial is for adults with advanced or metastatic solid tumors, including gastrointestinal cancers and MSI-H colorectal cancer that didn't respond to standard treatments. Participants must have measurable disease, be in good physical condition (ECOG score 0-1), and meet specific blood count and organ function criteria. Women of childbearing potential must test negative for pregnancy and agree to use contraception.
What is being tested?
The study tests TACH101's safety, tolerability, dosage levels, how the body processes it, and its effectiveness against tumors. It has two parts: Phase 1a finds the highest dose patients can take without serious side effects; Phase 1b determines a recommended dose for future studies based on responses from participants.
What are the potential side effects?
While specific side effects of TACH101 are not listed here, common ones in trials like this may include nausea, fatigue, diarrhea, liver enzyme changes leading to potential liver damage or inflammation issues affecting other organs.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active or can carry out light work.
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I am 18 years old or older.
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My advanced cancer can be measured by standard criteria.
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I have recovered from side effects of previous treatments, except for hair loss or appetite loss.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not have serious heart conditions like heart attacks, uncontrolled high blood pressure, or irregular heartbeats.
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I am not currently on cancer treatment and do not have HIV, hepatitis B, or C.
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I have liver or kidney disease.
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I have not had major surgery in the last 2 months.
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I have received a stem cell transplant from a donor.
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I have or might have cancer spread to my brain.
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I have not had surgery to remove my stomach or upper bowel, nor do I have a digestive condition that affects drug absorption.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ lead-in day 1 to end of treatment (up to approximately 204 days)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~lead-in day 1 to end of treatment (up to approximately 204 days)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Secondary study objectives
Phase 1a Dose Escalation: Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Phase 1b Dose Expansion: Number of Participants With TEAEs
Trial Design
2Treatment groups
Experimental Treatment
Group I: Phase 1b: Dose ExpansionExperimental Treatment1 Intervention
In Phase 1b, participants will receive TACH101 at the RP2D identified in Phase 1a. Two cohorts of participants will be enrolled:
* Participants with gastrointestinal cancers.
* Participants with high microsatellite instability (MSI-H) metastatic colorectal cancer (CRC).
Group II: Phase 1a: Dose EscalationExperimental Treatment1 Intervention
In Phase 1a, participants will receive TACH101 in a 48 hour lead in period followed by repeated dosing at different dosing regimens in each 28 day cycle.
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for solid tumors include targeted therapies, immunotherapies, and traditional chemotherapies. Targeted therapies, like TACH101, work by specifically inhibiting molecular pathways essential for tumor growth and survival, thereby minimizing damage to normal cells.
Immunotherapies enhance the body's immune system to recognize and attack cancer cells, offering a more personalized treatment approach. Traditional chemotherapies kill rapidly dividing cells but can affect both cancerous and healthy cells.
Understanding these mechanisms is crucial for solid tumor patients as it helps in selecting the most effective treatment with the least side effects, improving overall outcomes and quality of life.
Current trends and future directions in the genetic therapy of human neoplastic disease.Genetically engineered mouse models: closing the gap between preclinical data and trial outcomes.
Current trends and future directions in the genetic therapy of human neoplastic disease.Genetically engineered mouse models: closing the gap between preclinical data and trial outcomes.
Find a Location
Who is running the clinical trial?
Tachyon Therapeutics, Inc.Lead Sponsor
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have serious heart conditions like heart attacks, uncontrolled high blood pressure, or irregular heartbeats.I have advanced GI tumors or MSI-H CRC that hasn't responded well to standard treatments.I am fully active or can carry out light work.My advanced cancer hasn't responded to treatment and there's no standard cure.I am 18 years old or older.My advanced cancer can be measured by standard criteria.I am not currently on cancer treatment and do not have HIV, hepatitis B, or C.I have liver or kidney disease.I have not had major surgery in the last 2 months.I have received a stem cell transplant from a donor.I have or might have cancer spread to my brain.I have recovered from side effects of previous treatments, except for hair loss or appetite loss.I do not have another type of cancer that could affect this treatment's safety or results.I have not had surgery to remove my stomach or upper bowel, nor do I have a digestive condition that affects drug absorption.
Research Study Groups:
This trial has the following groups:- Group 1: Phase 1a: Dose Escalation
- Group 2: Phase 1b: Dose Expansion
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.
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