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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
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 belowSelect...
I am fully active or restricted in physically strenuous activity but can do light work.
Select...
My cancer progressed after 2 cycles of initial anti-PD-1 or anti-PD-L1 treatment.
Select...
My liver cancer is advanced, can't be removed by surgery, and was confirmed by tests.
Select...
My cancer has worsened despite up to 3 different treatments.
Select...
I am 18 years old or older.
Select...
I have liver cancer that cannot be removed by surgery and haven't received any systemic treatment for it.
Select...
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:Select...
I have not had extensive radiotherapy or a bone marrow transplant in the last 5 years.
Select...
I have had cancer spread to the lining of my brain and spinal cord.
Select...
I stopped my previous anti-PD-1 or anti-PD-L1 treatment for reasons not related to my disease getting worse.
Select...
I understand and can follow the study's instructions and requirements.
Select...
My liver cancer is a specific type or a mix of HCC and cholangiocarcinoma.
Select...
I use certain herbal treatments.
Select...
I have serious heart, lung, or stomach/intestine conditions.
Select...
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
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
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
~10
Bevacizumab
FDA approved
Find a Location
Who is running the clinical trial?
Tvardi Therapeutics, IncorporatedLead Sponsor
4 Previous Clinical Trials
176 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I agree to use birth control.I have a history of certain medical conditions or infections.I am fully active or restricted in physically strenuous activity but can do light work.I have not had extensive radiotherapy or a bone marrow transplant in the last 5 years.My cancer progressed after 2 cycles of initial anti-PD-1 or anti-PD-L1 treatment.I have had cancer spread to the lining of my brain and spinal cord.I have been treated with a STAT inhibitor or specific therapies recently.I stopped my previous anti-PD-1 or anti-PD-L1 treatment for reasons not related to my disease getting worse.I can swallow pills.I understand and can follow the study's instructions and requirements.My liver cancer is a specific type or a mix of HCC and cholangiocarcinoma.I am 18 years old or older.I still have symptoms from COVID-19.I am experiencing side effects from previous treatments.I use certain herbal treatments.I meet the specific health and treatment history requirements for Cohort C.I have serious heart, lung, or stomach/intestine conditions.I have not had live vaccines or immune diseases relevant to the study's conditions.I am willing to give a fresh tumor sample before joining the study.I have liver cancer that cannot be removed by surgery and haven't received any systemic treatment for it.I am not pregnant and agree to use effective birth control.My blood and organ tests meet the required health standards.My liver cancer is advanced, can't be removed by surgery, and was confirmed by tests.My cancer has worsened despite up to 3 different treatments.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort A: TTI-101 as a Single Agent
- Group 2: Cohort B: TTI-101 in Combination with Pembrolizumab
- Group 3: Cohort C: TTI-101 in Combination with Atezolizumab and Bevacizumab
Awards:
This trial has 2 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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