What side effects are associated with this type of intervention?

Common treatments for solid tumors, such as chemotherapy, targeted therapy, and immunotherapy, often have a range of side effects. Chemotherapy can cause myelosuppression, leading to anemia, neutropenia, and thrombocytopenia, as well as gastrointestinal issues like nausea, vomiting, and diarrhea. Targeted therapies, which inhibit specific molecules involved in tumor growth, may result in skin rashes, hypertension, and liver toxicity. Immunotherapies, which enhance the body's immune response against cancer cells, can lead to immune-related adverse events such as colitis, pneumonitis, and endocrinopathies. These side effects reflect the broad impact of these treatments on both cancerous and healthy cells.

What prior FDA approvals exist?

Several FDA-approved drugs have demonstrated antitumor activity in the treatment of solid tumors. These include immune checkpoint inhibitors like pembrolizumab and nivolumab, which target PD-1/PD-L1 pathways to enhance the immune system's ability to fight cancer. Additionally, targeted therapies such as olaparib, a PARP inhibitor, have been approved for specific genetic mutations in ovarian and breast cancers. Chemotherapeutic agents like temozolomide have also been used, particularly in glioblastoma, despite associated risks of secondary malignancies and liver toxicity. These treatments share a focus on safety, tolerability, and efficacy in managing advanced or metastatic solid tumors, similar to the objectives of the TACH101 study.

What other types of research exist?

Promising novel alternatives to TACH101 for solid tumor patients include: 1) TAT-T9sP, which inhibits proliferation and migration and promotes apoptosis in glioma cells by regulating the MKK6/p38 signaling pathway. 2) NSC48300, a reversible, noncompetitive inhibitor of Taspase1, which has shown effective tumor growth inhibition in breast and brain cancer models. 3) PRI-2191, a vitamin D analog that may counteract the renewal of cancer cells following conventional treatment. 4) Cabozantinib (XL184), an oral tyrosine kinase inhibitor, which has shown activity in medullary thyroid cancer and other solid tumors.

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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

No Placebo-Only Group

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 below

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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:

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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)

This trial's timeline: 3 weeks for screening, Varies for treatment, and lead-in day 1 to end of treatment (up to approximately 204 days) for reporting.

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 11Eligibility criteria met

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.