TTI-101 for Breast Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Washington University School of Medicine Siteman Cancer Center, Saint Louis, MO
Breast Cancer+1 More
TTI-101 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

The primary objectives of the Phase 1b part of this study are to evaluate the safety and tolerability of TTI-101 when added to palbociclib and aromatase inhibitor (AI) administered orally to participants with estrogen receptor-positive (ER+) human epithelial receptor 2-negative (HER2-) palbociclib-resistant breast cancer, and to determine the recommended Phase 2 dose (RP2D) for TTI-101 when added to palbociclib and AI. The primary objective of the Phase 2 part of this study is to evaluate tumor response by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 criteria in participants who receive TTI-101 added to palbociclib and AI.

Eligible Conditions

  • Breast Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Breast Cancer

Study Objectives

4 Primary · 13 Secondary · Reporting Duration: Up to approximately 18 months

Month 18
Phase 1b and Phase 2: Pharmacodynamics of TTI-101 as Measured By Change from Baseline in Percentage of Phosphorylated Signal Transducer and Activator of Transcription 1 (pY-STAT1) Positive Cells in Tumor Biopsy Samples
Phase 1b and Phase 2: Pharmacodynamics of TTI-101 as Measured By Change from Baseline in Percentage of Phosphorylated Signal Transducer and Activator of Transcription 3 (pY-STAT3) Positive Cells in Tumor Biopsy Samples
Phase 1b and Phase 2: Pharmacodynamics of TTI-101 as Measured By Change from Baseline in Percentage of Phosphorylated Signal Transducer and Activator of Transcription 5 (pY-STAT5) Positive Cells in Tumor Biopsy Samples
Day 28
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: Maximum Observed Plasma Concentration (Cmax) of TTI-101
Phase 1b and Phase 2: Time of Maximum Observed Plasma Concentration (Tmax) of TTI-101
Day 28
Phase 1b: Number of Participants Who Experience a Dose Limiting Toxicity (DLT)
Month 18
Phase 1b and Phase 2: Best Overall Response (BOR)
Phase 1b and Phase 2: Duration of Response (DoR) to Treatment
Phase 1b and Phase 2: Overall Response Rate (ORR)
Phase 1b and Phase 2: Progression-free Survival (PFS)
Phase 1b and Phase 2: Time to Tumor Progression (TTP)
Phase 1b: Clinical Benefit Rate (CBR)
Phase 1b: Number of Participants Who Experience a Serious Adverse Event (SAE)
Phase 1b: Number of Participants Who Experience an Adverse Event (AE)
Phase 2: Clinical Benefit Rate (CBR)
Month 6
Phase 1b and Phase 2: Progression-free Survival (PFS) at 6 Months

Trial Safety

Safety Progress

1 of 3

Other trials for Breast Cancer

Trial Design

2 Treatment Groups

Phase 2: Dose Expansion
1 of 2
Phase 1b: Dose Escalation
1 of 2
Experimental Treatment

53 Total Participants · 2 Treatment Groups

Primary Treatment: TTI-101 · No Placebo Group · Phase 1 & 2

Phase 2: Dose ExpansionExperimental Group · 3 Interventions: TTI-101, Aromatase inhibitor (AI), Palbociclib · Intervention Types: Drug, Drug, Drug
Phase 1b: Dose EscalationExperimental Group · 3 Interventions: TTI-101, Aromatase inhibitor (AI), Palbociclib · Intervention Types: Drug, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Palbociclib
2017
Completed Phase 3
~4210

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to approximately 18 months
Closest Location: Washington University School of Medicine Siteman Cancer Center · Saint Louis, MO
Photo of Saint Louis 1Photo of Saint Louis 2Photo of Saint Louis 3
2018First Recorded Clinical Trial
5 TrialsResearching Breast Cancer
7 CompletedClinical Trials

Who is running the clinical trial?

Tvardi Therapeutics, IncorporatedLead Sponsor
2 Previous Clinical Trials
214 Total Patients Enrolled
1 Trials studying Breast Cancer
60 Patients Enrolled for Breast Cancer

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have metastatic or locally advanced breast cancer that is not amenable to curative treatment by surgery or radiotherapy.
You are a man or premenopausal woman who is on gonadal suppression therapy with a gonadotropin analog and has estrogen levels in the postmenopausal range by institutional criteria at baseline.
The participant must have had one prior line of systemic treatment (palbociclib and AI) in the locally advanced or metastatic setting prior to enrollment.
You have an ECOG performance status of 0 or 1.
You are willing to provide a representative fresh tumor tissue specimen prior to enrollment
The presence of measurable disease as per RECIST Version 1.1 is required

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.