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Hormone Therapy

TTI-101 Combination Therapy for Breast Cancer

Phase 1 & 2

Waitlist Available

Research Sponsored by Tvardi Therapeutics, Incorporated

Eligibility Criteria Checklist

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

Must have

Metastatic or locally advanced breast cancer not amenable to curative treatment by surgery or radiotherapy

Currently receiving palbociclib and AI or fulvestrant for Phase 1b, or currently receiving palbociclib or ribociclib and AI or fulvistrant therapy in the metastatic setting with evidence of progressive disease for Phase 2

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 18 months

Awards & highlights

Study Summary

This trial is testing a new drug, TTI-101, to see if it is safe and effective when added to palbociclib and aromatase inhibitor to treat breast cancer that is resistant to palbociclib. The trial will also determine the recommended dose of TTI-101 for the next phase of the trial.

Who is the study for?

This trial is for adults with hormone receptor-positive, HER2-negative breast cancer that's resistant to palbociclib. They must have been on palbociclib or ribociclib and AI or fulvestrant for at least 6 months, have an ECOG status of 0 or 1, and can't have had more than two systemic treatments before. Men and premenopausal women need gonadal suppression therapy.Check my eligibility

What is being tested?

The study tests the safety and effectiveness of TTI-101 combined with existing drugs (palbociclib/ribociclib and AI/fulvestrant) in patients whose breast cancer has resisted treatment. Phase 1 determines the safe dose; Phase 2 checks how well it works against tumors.See study design

What are the potential side effects?

Possible side effects include those common to cancer therapies such as fatigue, nausea, blood count changes, hormonal imbalances due to AI use, potential liver issues from TTI-101, and reactions related to immune system modulation.

Eligibility Criteria

Inclusion Criteria

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

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My breast cancer cannot be cured with surgery or radiation.

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I am currently on palbociclib and AI or fulvestrant for Phase 1b, or on palbociclib or ribociclib and AI or fulvestrant with my cancer getting worse.

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I am fully active or restricted in physically strenuous activity but can do light work.

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I am on hormone therapy to lower my sex hormone levels to postmenopausal levels.

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I am 18 years old or older.

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My breast cancer is HR-positive and HER2-negative.

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My medication doses for my cancer treatment have not changed recently.

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I can provide a fresh tumor sample for the study, unless my cancer is only in the bones.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 18 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 18 months

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

Phase 1b: Number of Participants Who Experience a Dose Limiting Toxicity (DLT)

Phase 1b: Number of Participants Who Experience a Serious Adverse Event (SAE)

Phase 1b: Number of Participants Who Experience an Adverse Event (AE)

+1 more

Secondary outcome measures

Phase 1b and Phase 2: Area Under the Plasma Concentration-time Curve from Time 0 to Time t (AUC[0-t]) of TTI-101

Phase 1b and Phase 2: Best Overall Response (BOR)

Phase 1b and Phase 2: Clinical Benefit Rate (CBR)

+10 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Phase 2: Dose ExpansionExperimental Treatment5 Interventions

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 added to palbociclib or ribociclib and AI or fulvestrant.

Group II: Phase 1b: Dose EscalationExperimental Treatment4 Interventions

Participants will receive up to 3 dose levels of TTI-101 added to palbociclib and AI or fulvestrant to determine the RP2D.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Palbociclib

2017

Completed Phase 3

~3760

fulvestrant

2012

Completed Phase 3

~2000

ribociclib

2016

Completed Phase 3

~560

0 / 8Eligibility criteria met

Find a Location

Who is running the clinical trial?

Tvardi Therapeutics, IncorporatedLead Sponsor

4 Previous Clinical Trials

349 Total Patients Enrolled

1 Trials studying Breast Cancer

60 Patients Enrolled for Breast Cancer

Media Library

Breast Cancer Clinical Trial 2023: Aromatase inhibitor (AI) Highlights & Side Effects. Trial Name: NCT05384119 — Phase 1 & 2

Frequently Asked Questions

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

What is the cap on enrollment in this trial?

"This medical trial requires a cohort of 53 volunteers that meet the predetermined eligibility requirements. Accepted participants can be located in various locations, like MD Anderson Cancer Center (Houston) and Gabrail Research Centre (Canton)."

Answered by AI