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Oral TACH101 for Cancer

Phase 1

Recruiting

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up cycle 1 day 1 up to cycle 1 day 28 (cycle length = 28 days)

Awards & highlights

Study Summary

This trialassesses the safety, effectiveness and side effects of a new oral cancer drug, TACH101, for people with advanced or metastatic solid tumors.

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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ cycle 1 day 1 up to cycle 1 day 28 (cycle length = 28 days)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~cycle 1 day 1 up to cycle 1 day 28 (cycle length = 28 days)

This trial's timeline: 3 weeks for screening, Varies for treatment, and cycle 1 day 1 up to cycle 1 day 28 (cycle length = 28 days) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Phase 1a Dose Escalation: MTD of TACH101

Phase 1a Dose Escalation: RP2D of TACH101

Phase 1b Dose Expansion: ORR

Secondary outcome measures

Phase 1a Dose Escalation: Apparent Clearance After Extravascular Administration (CL/F) of TACH101

Phase 1a Dose Escalation: Apparent Terminal Elimination Half-life (t1/2) of TACH101

Phase 1a Dose Escalation: Apparent Volume of Distribution During the Terminal Phase After Extravascular Administration (Vz/F) of TACH101

+15 more

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 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Tachyon Therapeutics, Inc.Lead Sponsor

Media Library

TACH101 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05076552 — Phase 1

Solid Tumors Research Study Groups: Phase 1a: Dose Escalation, Phase 1b: Dose Expansion

Solid Tumors Clinical Trial 2023: TACH101 Highlights & Side Effects. Trial Name: NCT05076552 — Phase 1

TACH101 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05076552 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA granted sanction to Phase 1a: Dose Escalation?

"Our experts at Power rated the safety rating of Phase 1a: Dose Escalation as a 1 due to its status as a Phase 1 trial, indicating that there is only sparse evidence confirming efficacy and limited data backing its safety."

Answered by AI

How many participants are included in this experiment?

"Affirmative. According to clinicaltrials.gov, this trial is in the process of selecting participants. It was posted on January 19th 2023 and most recently edited on January 25th 2023, with a need for 70 volunteers from one medical site."

Answered by AI

Are there any open opportunities for participants to join this clinical investigation?

"Affirmative. The clinicaltrials.gov database reveals that this research is currently in need of volunteers. It was initially posted on January 19th 2023 and recently revised on the 25th of the same month. 70 individuals have to be recruited from just one trial site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Assess the Safety, Pharmacokinetics, and Antitumor Activity of Oral TACH101 in Participants With Advanced or Metastatic Cancer

2023. "A Study to Assess the Safety, Pharmacokinetics, and Antitumor Activity of Oral TACH101 in Participants With Advanced or Metastatic Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05076552.