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TTI-101 Combination Therapy for Liver Cancer

Phase 1 & 2

Recruiting

Research Sponsored by Tvardi Therapeutics, Incorporated

Eligibility Criteria Checklist

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

Must have

Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

For Cohort B: Demonstrated objective progression following at least 2 cycles of first-line anti-PD-1 or anti-PD-L1 therapy.

Must not have

Extensive prior radiotherapy or bone marrow/stem cell transplantation within 5 years.

History of leptomeningeal disease.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 20 months

Awards & highlights

No Placebo-Only Group

All Individual Drugs Already Approved

Summary

This trial evaluates the safety, tolerability and efficacy of TTI-101 when given alone or in combination with other drugs to treat HCC.

Who is the study for?

This trial is for adults with advanced, inoperable liver cancer who can swallow pills and provide informed consent. Participants must have measurable disease, good performance status, and adequate organ function. Cohort C requires no prior systemic treatment for liver cancer and agreement to use contraception. Exclusions include pregnancy, breastfeeding, recent COVID-19 recovery issues, uncontrolled medical conditions, certain past treatments including STAT inhibitors or immunotherapies (unless due to disease progression), and specific health histories.

What is being tested?

The study tests TTI-101 alone (Cohort A) or combined with pembrolizumab (Cohort B) or atezolizumab plus bevacizumab (Cohort C). It aims to find the safest dose that's also effective against unresectable hepatocellular carcinoma by observing safety/tolerability and preliminary efficacy. The trial will also assess how the body processes these drugs.

What are the potential side effects?

Potential side effects may include typical reactions from oral medications like digestive discomfort as well as those associated with immune therapies such as fatigue, skin reactions, inflammation of organs or infusion-related responses. Specific risks related to each drug combination will be monitored closely.

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 restricted in physically strenuous activity but can do light work.

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My cancer progressed after 2 cycles of initial anti-PD-1 or anti-PD-L1 treatment.

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My liver cancer is advanced, can't be removed by surgery, and was confirmed by tests.

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My cancer has worsened despite up to 3 different treatments.

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I am 18 years old or older.

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I have liver cancer that cannot be removed by surgery and haven't received any systemic treatment for it.

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I am not pregnant and agree to use effective birth control.

Exclusion Criteria

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

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I have not had extensive radiotherapy or a bone marrow transplant in the last 5 years.

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I have had cancer spread to the lining of my brain and spinal cord.

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I stopped my previous anti-PD-1 or anti-PD-L1 treatment for reasons not related to my disease getting worse.

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I understand and can follow the study's instructions and requirements.

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My liver cancer is a specific type or a mix of HCC and cholangiocarcinoma.

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I use certain herbal treatments.

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I have serious heart, lung, or stomach/intestine conditions.

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I have not had live vaccines or immune diseases relevant to the study's conditions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 20 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 20 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 20 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

Incidence of Adverse Events (AE)

Phase 2: Overall Response Rate (ORR) to TTI-101

Secondary study objectives

Phase 1b: Overall Response Rate (ORR) to TTI-101

Awards & Highlights

No Placebo-Only Group

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

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

3Treatment groups

Experimental Treatment

Group I: Cohort C: TTI-101 in Combination with Atezolizumab and BevacizumabExperimental Treatment3 Interventions

Cohort C Phase 1b: Participants will receive various dose levels of TTI-101 in combination with atezolizumab and bevacizumab to determine the RP2D. Cohort C Phase 2: Enrollment in Phase 2 may commence with approval from the safety review committee. Participants will be enrolled and treated at the RP2D of TTI-101 in combination with atezolizumab and bevacizumab.

Group II: Cohort B: TTI-101 in Combination with PembrolizumabExperimental Treatment2 Interventions

Cohort B Phase 1b: Participants will receive various dose levels of TTI-101 in combination with pembrolizumab to determine the RP2D. Cohort B Phase 2: Enrollment in Phase 2 may commence with approval from the safety review committee. Participants will be enrolled and treated at the RP2D of TTI-101 in combination with pembrolizumab.

Group III: Cohort A: TTI-101 as a Single AgentExperimental Treatment1 Intervention

Cohort A Phase 1b: Participants will receive various dose levels of TTI-101 as a single agent to determine the RP2D. Cohort A Phase 2: Enrollment in Phase 2 may commence with approval from the safety review committee. Participants will be enrolled and treated at the RP2D of TTI-101 as a single agent.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

FDA approved

Atezolizumab

FDA approved

TTI-101

2023

Completed Phase 2

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