[177Lu]Lu-NeoB in Combination With Ribociclib and Fulvestrant in Participants With ER+, HER2- and GRPR+ Advanced Breast Cancer

Part of paid clinical trials in Los Angeles, California.

Sponsor
Novartis Pharmaceuticals
Study ID
NCT05870579
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • [68Ga]Ga-NeoB — DRUG
    \[68Ga\]Ga-NeoB serves as a radioactive imaging compound to be used for PET imaging for localization of GRPR positive lesions, at screening, potentially at Cycle 2 Day 15 visit, and between 4 and 8 weeks after the last administered dose of \[177Lu\]Lu-NeoB. \[68Ga\]Ga-NeoB will be administered as a single intravenous (i.v.) dose.
  • [177Lu]Lu-NeoB — DRUG
    Study participants will receive \[177Lu\]Lu-NeoB once every cycle
  • Ribociclib — DRUG
    600 mg once daily (OD) days 1 to 21 every 28 days
  • Fulvestrant — DRUG
    500 mg at Cycle 1 Day 1, Cycle 1 Day 15, Cycle 2 Day 1 and every 28 days thereafter
  • Goserelin — OTHER
    For pre/peri-menopausal women and men only.

Study Details

The purpose of this trial is to estimate the recommended dose (RD) of \[177Lu\]Lu-NeoB in combination with ribociclib and fulvestrant in participants with estrogen receptor (ER) positive (ER+), human epidermal growth factor receptor-2 (HER2) negative (HER2-) and gastrin releasing peptide receptor (GRPR) positive (GRPR+) advanced breast cancer experiencing early relapse from (neo)adjuvant endocrine therapy or who have progressed on endocrine therapy in combination with a CDK4/6 inhibitor for advanced disease.

Key Dates

Start date
Nov 13, 2023
Status verified
Jun 2026
Primary completion
Dec 30, 2026
Completion
Apr 5, 2032

Study Design

Enrollment
48 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1
    Participants will receive \[177Lu\]Lu- NeoB in combination with ribociclib and fulvestrant, in the dose escalation and the backfill parts of the study. Goserelin administration is only applicable for pre/peri-menopausal women and men.

Primary Outcome Measure

Incidence and nature of DLTs during the DLT observation period [ Time Frame: 28 days after the first administration of [177Lu]Lu-NeoB ]

Central Contacts

Locations (6)

FacilityCityStateZIPSite coordinators
UCLA Jonsson Comp Cancer CenterLos AngelesCalifornia90095-
Hoag Memorial Hospital PresbyterianNewport BeachCalifornia92663
Beth Thomsen
[email protected]
Gary Ulaner (PRINCIPAL_INVESTIGATOR)
University of Kansas Medical CenterWestwoodKansas66205
Jordan Rarden
[email protected]
913-588-6030
Yiduo Hu (PRINCIPAL_INVESTIGATOR)
University of PennsylvaniaPhiladelphiaPennsylvania19104-
MD Anderson Cancer CenterHoustonTexas77030-
Utah Intermountain Medical CenterMurrayUtah84107-

Find similar trials in Los Angeles, CA

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
UCLA Jonsson Comp Cancer Center· Los Angeles, CAHoag Memorial Hospital Presbyterian· Newport Beach, CAUniversity of Kansas Medical Center· Westwood, KSUniversity of Pennsylvania· Philadelphia, PAMD Anderson Cancer Center· Houston, TXUtah Intermountain Medical Center· Murray, UT

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