Phase 1b/2 Study of TTI-101 in Combination for Patients With Metastatic Hormone Receptor-Positive and HER2-Negative Breast Cancer

Part of paid clinical trials in Fort Lauderdale, Florida.

Sponsor
Tvardi Therapeutics, Incorporated
Study ID
NCT05384119
Phase
PHASE1
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • TTI-101 — DRUG
    Oral tablet
  • Palbociclib — DRUG
    Oral capsule
  • Aromatase inhibitor (AI) — DRUG
    Oral tablet
  • fulvestrant — DRUG
    Oral tablet
  • ribociclib — DRUG
    Oral tablet

Study Details

The primary objective of Phase 1b will be to evaluate the safety and tolerability of TTI-101 when added to palbociclib and AI or fulvestrant administered orally to participants with hormone receptor-positive (HR+) human epidermal 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 or fulvestrant. The primary objective of Phase 2 will be to evaluate anti-tumor activity in participants who receive TTI-101 added to palbociclib or ribociclib and AI or fulvestrant.

Key Dates

Start date
Jan 9, 2023
Status verified
Feb 2025
Primary completion
Apr 25, 2024
Completion
Apr 25, 2024

Study Design

Enrollment
6 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase 1b: Dose Escalation
    Participants will receive up to 3 dose levels of TTI-101 added to palbociclib and AI or fulvestrant to determine the RP2D.
  • Experimental: Phase 2: Dose Expansion
    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.

Primary Outcome Measure

Phase 1b: Number of Participants Who Experience a Dose Limiting Toxicity (DLT) [ Time Frame: Day 1 to Day 28 ]

Locations (6)

FacilityCityStateZIPSite coordinators
Holy Cross Health Fort Lauderdale - Holy Cross HospitalFort LauderdaleFlorida33308-
Washington University School of Medicine Siteman Cancer CenterSt LouisMissouri63110-
Vanderbilt - Ingram Cancer CenterNashvilleTennessee37232-
Harold C. Simmons Comprehensive Cancer CenterDallasTexas75390-
Texas Oncology - Dallas Fort Worth (DFW) - Baylor Charles A. Sammons Cancer CenterDallasTexas75246-
University of Texas MD Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Fort Lauderdale, FL

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Holy Cross Health Fort Lauderdale - Holy Cross Hospital· Fort Lauderdale, FLWashington University School of Medicine Siteman Cancer Center· St Louis, MOVanderbilt - Ingram Cancer Center· Nashville, TNHarold C. Simmons Comprehensive Cancer Center· Dallas, TXTexas Oncology - Dallas Fort Worth (DFW) - Baylor Charles A. Sammons Cancer Center· Dallas, TXUniversity of Texas MD Anderson Cancer Center· Houston, TX

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