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STAT3 Inhibitor

Oral STAT3 Inhibitor for Cancer

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

Must not have

Extensive prior radiotherapy on more than 30% of bone marrow reserves, or prior bone marrow/stem cell transplantation within 5 years from enrollment; Ongoing toxicity (except alopecia) due to a prior therapy, unless returned to baseline or Grade 1 or less

Major surgical intervention or participation in a therapeutic clinical trial within 28 days from Day 1 of the first dose of TTI-101

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 18 months

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I haven't had extensive radiation on over 30% of my bone marrow or a bone marrow transplant in the last 5 years, and any side effects from past treatments are mild or gone.

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I haven't had major surgery or joined a clinical trial in the last 28 days.

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My heart is healthy and I haven't had serious heart issues in the last year.

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My blood pressure is not higher than 160/100 mm Hg.

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I haven't taken any experimental drugs within the last 28 days.

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I have been treated with a STAT inhibitor for my current cancer.

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I haven't had cancer treatments like chemotherapy or immunotherapy in the last 28 days.

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I am HIV positive.

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I am legally unable to make my own decisions.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Maximum Tolerated Dose of TTI-101

Pharmacokinetics - AUC(0-t)

Pharmacokinetics - Cmax

+1 more

Secondary study objectives

Best Overall Response

Complete Response (CR) - Non-target Lesions

Complete Response (CR) - Target Lesions

+6 more

Other study objectives

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.

Awards & Highlights

No Placebo-Only Group

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

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

TTI-101

2023

Completed Phase 2

~10

0 / 15Eligibility criteria met