A Phase 1 Study of 68Ga-R11228 and 177Lu-R11228 in Breast Cancer

Part of paid clinical trials in Indianapolis, Indiana.

Sponsor
Radionetics Oncology
Study ID
NCT07121244
Phase
PHASE1
Status
Recruiting
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Conditions

  • Locoregionally Recurrent Hormone-receptor Positive Breast Cancer
  • Metastatic Hormone Receptor Positive Breast Cancer

Eligibility Criteria

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

Interventions

  • 68Ga-R11228 — DRUG
    68Ga-R11228 is a gallium-labeled small molecule radioligand that is designed to localize tumor lesions
  • 177Lu-R11228 — DRUG
    177Lu-R11228 is a lutetium-labeled small molecule radioligand designed to treat tumor lesions

Study Details

A phase 1 study of 68Ga-R11228 and 177Lu-R11228 in breast cancer.

Key Dates

Start date
Oct 1, 2025
Status verified
Apr 2026
Primary completion
Jun 1, 2028
Completion
Jun 1, 2033

Study Design

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

Arms

  • Experimental: Part A: 68Ga-R11228 Dose Optimization Portion
    68Ga-R11228 injection at pre-defined dose levels.
  • Experimental: Part B: 68Ga-R11228 Imaging and 177Lu-R11228 Dose Ranging Portion
    68Ga-R11228 injection at pre-defined dose. 177Lu-R11228 injection at pre-defined doses.

Primary Outcome Measure

Incidence of adverse events [68Ga-R11228] [ Time Frame: Day 1 to Day 7 ]

Central Contacts

Locations (6)

FacilityCityStateZIPSite coordinators
Indiana University Melvin and Bren Simon Cancer CenterIndianapolisIndiana46202
Xin Bryan
[email protected]
317 274 5495
United TheranosticsGlen BurnieMaryland21061
Amanda Huggins
[email protected]
667-HOPENOW
United Theranostics PrincetonPrincetonNew Jersey08540
Amanda Huggins
[email protected]
667-HOPENOW
University Hospital Seidman Cancer CenterClevelandOhio44106
Alberto Montero
[email protected]
(216) 844-3951
MD Anderson Cancer CenterHoustonTexas77030
Nathan Comeaux
[email protected]
University of Utah - Huntsman Cancer InstituteSalt Lake CityUtah84112
Blake Nordblad
[email protected]

Find similar trials in Indianapolis, IN

By research site
Indiana University Melvin and Bren Simon Cancer Center· Indianapolis, INUnited Theranostics· Glen Burnie, MDUnited Theranostics Princeton· Princeton, NJUniversity Hospital Seidman Cancer Center· Cleveland, OHMD Anderson Cancer Center· Houston, TXUniversity of Utah - Huntsman Cancer Institute· Salt Lake City, UT

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