VS-6766+Abema+Fulv in Met HR+/HER- BC

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Adrienne G. Waks
Study ID
NCT05608252
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Breast Cancer
  • Hormone Receptor Positive HER-2 Negative Breast Cancer
  • Hormone Receptor-positive Breast Cancer

Eligibility Criteria

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

Interventions

  • VS-6766 — DRUG
    Taken Orally
  • Abemaciclib — DRUG
    Taken Orally
  • Fulvestrant — DRUG
    Administered by intramuscular injection

Study Details

This research is being done to evaluate the safety and effectiveness of a drug currently known as VS-6766 in combination with the drugs abemaciclib and fulvestrant in HR+/HER2-negative breast cancer. The names of the study drugs involved in this study are: * VS-6766 * Abemaciclib * Fulvestrant

Key Dates

First listed
Nov 8, 2022
Start date
Feb 23, 2023
Status verified
Apr 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2028

Study Design

Enrollment
63 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase 1 Dose Escalation
    During 28 day/4 week study cycle, participants will receive: * VS-6766 2x weekly for 3 out of the 4 week cycle * Abemaciclib 2x daily * Fulvestrant on day 1 of each study cycle (and day 15 of cycle 1 only)
  • Experimental: Phase 2 Dose Expansion
    Participants will receive VS-6766 with abemaciclib and fulvestrant at the recommended phase II doses determined in the phase I portion of the study.

Primary Outcome Measure

Phase 1 Maximum tolerated dose (MTD) [ Time Frame: 4 Weeks up to 2 years ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Brigham and Women's HospitalBostonMassachusetts02115
Adrienne G Waks, MD
[email protected]
617-632-3800
Adrienne G Waks, MD (PRINCIPAL_INVESTIGATOR)
Dana Farber Cancer InstititeBostonMassachusetts02115
Adrienne G Waks, MD
[email protected]
617-632-3800
Adrienne G Waks, MD (PRINCIPAL_INVESTIGATOR)
Massachusetts General Hospital Cancer CenterBostonMassachusetts02114-

Find similar trials in Boston, MA

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Brigham and Women's Hospital· Boston, MADana Farber Cancer Institite· Boston, MAMassachusetts General Hospital Cancer Center· Boston, MA

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