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STAT3 Inhibitor

Oral STAT3 Inhibitor for Cancer

Q: Is geriatric participation allowed in this investigation?

The cut-off age for this clinical trial is 65 and the minimum age requirement to enroll is 18 years old.

Q: What are the major aims of this medical study?

The principal purpose of the 18-month evaluation is to ascertain the Maximum Tolerated Dose of TTI-101. Secondary objectives include measuring Partial Response (PR) - Target Lesions, that being a 30% decrease in target lesion diameters from baseline; Pharmacodynamics of TTI-101 in patients, quantified by pY-STAT3 levels prior and after medication administration; and Progressive Disease (PD) - Target Lesions which necessitates an absolute increase of 5 mm with a relative change exceeding 20%.

Q: Are there unfilled slots available in this research project?

According to clinicaltrials.gov, this particular study is not currently recruiting patients; the medical project was first posted in November 2017 and last updated October 2022. However, there are still 6533 other trials presently looking for volunteers.

Phase 1

Waitlist Available

Led By Apostolia Tsimberidou, MD, PhD

Research Sponsored by Tvardi Therapeutics, Incorporated

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥18 years

For patients with unresectable HCC: Patients with histologically confirmed diagnosis of locally advanced, inoperable, unresectable HCC who have failed first and second lines of therapy and Child-Pugh is A or beyond second line if the performance status is preserved and Child-Pugh is A

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 18 months

Awards & highlights

Study Summary

This trial will test a new compound, TTI-101, which is a direct inhibitor of the protein STAT3. This protein is involved in the development and growth of many types of cancer, but there is no current drug that targets it. TTI-101 will be given orally to patients with various types of solid tumors, to determine if it is safe and effective in reducing the growth of these tumors.

Who is the study for?

Adults (18+) with advanced cancers like stomach, liver, breast, lung cancer and more. They must have tried other treatments without success or have no other beneficial options left. Good organ function is required, especially for the liver and kidneys. Women of childbearing age need a negative pregnancy test and agree to avoid pregnancy; men also need to use contraception.Check my eligibility

What is being tested?

The trial tests TTI-101, an oral drug targeting STAT3 protein involved in cancer growth. It's for patients whose solid tumors are advanced or resistant to treatment. The goal is to see if it's safe for humans, can effectively block STAT3 in their cancer cells, and slow down tumor growth.See study design

What are the potential side effects?

Specific side effects aren't listed but based on similar drugs' profiles: potential risks may include allergic reactions related to its chemical class (hydroxyl-naphthalene sulfonamides), digestive issues due to swallowing difficulties or malabsorption conditions mentioned in exclusion criteria.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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My liver cancer cannot be removed by surgery, and I've tried at least two treatments without success.

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I am fully active or can carry out light work.

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My kidneys work well enough, with a creatinine clearance over 40 ml/min.

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My liver functions within the normal range required.

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My solid tumor is advanced, inoperable, or has not responded to treatment, and no other therapies are expected to help.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 18 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~18 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 18 months for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Maximum Tolerated Dose of TTI-101

Pharmacokinetics - AUC(0-t)

Pharmacokinetics - Cmax

+1 more

Secondary outcome measures

Best Overall Response

Complete Response (CR) - Non-target Lesions

Complete Response (CR) - Target Lesions

+6 more

Other outcome measures

Assess the bioavailability between different formulations of TTI-101

Assess the effect of food on bioavailability

Explore association between biomarkers and antitumor efficacy and survival outcome based on RECIST 1.1 for uHCC patients.

Trial Design

4Treatment groups

Experimental Treatment

Group I: Food effect studyExperimental Treatment1 Intervention

Participants will be treated with TTI-101 at the RP2D under fed and fasted conditions to assess the bioavailability of TTI-101 and to determine the best conditions for taking the study drug

Group II: Dose expansion, cross-over studyExperimental Treatment1 Intervention

Participants will be administered different formulations of TTI-101 to compare bioavailability.

Group III: Dose expansion studyExperimental Treatment1 Intervention

Enrollment in the dose expansion may commence with approval from the safety review committee. Participants will be enrolled and treated at the RP2D of TTI-101

Group IV: Dose escalation studyExperimental Treatment1 Intervention

Participants will receive up to 4 dose levels of TTI-101 to determine RP2D

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

Tvardi Therapeutics, IncorporatedLead Sponsor

4 Previous Clinical Trials

295 Total Patients Enrolled

M.D. Anderson Cancer CenterOTHER

2,967 Previous Clinical Trials

1,804,742 Total Patients Enrolled

Apostolia Tsimberidou, MD, PhDPrincipal InvestigatorThe University of Texas MD Anderson Cancer Center

3 Previous Clinical Trials

98 Total Patients Enrolled

Media Library

TTI-101 (STAT3 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03195699 — Phase 1

Stomach Cancer Research Study Groups: Food effect study, Dose expansion, cross-over study, Dose expansion study, Dose escalation study

Stomach Cancer Clinical Trial 2023: TTI-101 Highlights & Side Effects. Trial Name: NCT03195699 — Phase 1

TTI-101 (STAT3 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03195699 — 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 U.S. Food & Drug Administration given its stamp of approval to TTI-101?

"Due to the limited data supporting TTI-101's efficacy and safety, we have evaluated it with a score of 1."

Answered by AI

For which type of participant is this research endeavor best suited?

"This clinical trial seeks sixty individuals aged 18 to 65 who have been diagnosed with melanoma. In addition, participants must meet the following criteria: (1) Eastern Cooperative Oncology Group Performance status 0-1; (2) Hemoglobin ≥9.0 g/dL, neutrophil count ≥1.0 x 109/L, platelets ≥75 x 109/L; (3) Adequate renal function capability as determined by creatinine clearance >40 ml/min using the Cockroft-Gault formula; (4) Adequate liver function defined as total bilirubin <1.5"

Answered by AI

Is geriatric participation allowed in this investigation?

"The cut-off age for this clinical trial is 65 and the minimum age requirement to enroll is 18 years old."

Answered by AI

What are the major aims of this medical study?

"The principal purpose of the 18-month evaluation is to ascertain the Maximum Tolerated Dose of TTI-101. Secondary objectives include measuring Partial Response (PR) - Target Lesions, that being a 30% decrease in target lesion diameters from baseline; Pharmacodynamics of TTI-101 in patients, quantified by pY-STAT3 levels prior and after medication administration; and Progressive Disease (PD) - Target Lesions which necessitates an absolute increase of 5 mm with a relative change exceeding 20%."

Answered by AI

Are there unfilled slots available in this research project?

"According to clinicaltrials.gov, this particular study is not currently recruiting patients; the medical project was first posted in November 2017 and last updated October 2022. However, there are still 6533 other trials presently looking for volunteers."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Oral STAT3 Inhibitor, TTI-101, in Patients With Advanced Cancers

2017. "Oral STAT3 Inhibitor, TTI-101, in Patients With Advanced Cancers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03195699.

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