A Phase I/II, Dose Finding and Optimization Study of [177Lu]Lu-NeoB in Combination With Capecitabine in Patients With GRPR+, ER+, HER2- Metastatic Breast Cancer After Progression on Previous Endocrine Therapy in Combination With a CDK4/6 Inhibitor.

Part of paid clinical trials in Los Angeles, California.

Sponsor
Novartis Pharmaceuticals
Study ID
NCT06247995
Phase
PHASE1/PHASE2
Status
Recruiting
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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.
  • [177Lu]Lu-NeoB — DRUG
    \[177Lu\]Lu-NeoB is a radioligand therapy drug.
  • Capecitabine — DRUG
    Capecitabine is a chemotherapy drug.

Study Details

In the phase I part, to determine the recommended doses (RD) and dosing regimens of \[177Lu\]Lu-NeoB in combination with capecitabine in adult patients with gastrin releasing peptide receptor positive, estrogen receptor-positive, human epidermal growth factor receptor-2 negative metastatic breast cancer after progression on previous endocrine therapy in combination with a CDK4/6 inhibitor. In the phase II part, to evaluate the preliminary anti-tumor activity of two different doses/regimens of \[177Lu\]Lu-NeoB in combination with capecitabine (dose optimization).

Key Dates

Start date
Aug 14, 2024
Status verified
Jun 2026
Primary completion
Sep 9, 2031
Completion
Sep 9, 2031

Study Design

Enrollment
58 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose A: [177Lu]Lu-NeoB 150mCi q6w + capecitabine
    \[177Lu\]Lu-NeoB 150mCi q6w + Capecitabine 1000mg/ m2 BID Day1-14 in a 21-day schedule
  • Experimental: Dose B: [177Lu]Lu-NeoB 100mCi q3w + capecitabine
    \[177Lu\]Lu-NeoB 100mCi q3w+ Capecitabine 1000mg/m2 BID Day1-14 in a 21-day schedule
  • Experimental: Dose C: [177Lu]Lu-NeoB 200mCi q6w + capecitabine
    \[177Lu\]Lu-NeoB 200mCi q6w + Capecitabine 1000mg/m2 BID Day1-14 in a 21-day schedule
  • Experimental: Dose D: [177Lu]Lu-NeoB 100mCi q6w + capecitabine
    \[177Lu\]Lu-NeoB 100mCi q6w + Capecitabine 1000mg/m2 BID Day1-14 in a 21-day schedule

Primary Outcome Measure

Phase I: Incidence and severity of dose limiting toxicities (DLTs) [ Time Frame: 42 days after the first administration of [177Lu]Lu-NeoB ]

Central Contacts

  • Novartis Pharmaceuticals
    1-888-669-6682
    [email protected]
  • Novartis Pharmaceuticals
    +41613241111

Locations (5)

FacilityCityStateZIPSite coordinators
UCLA Medical CenterLos AngelesCalifornia90095
Monica Rocha
[email protected]
Aditya Bardia (PRINCIPAL_INVESTIGATOR)
Hoag Memorial Hospital PresbyterianNewport BeachCalifornia92663
Geo Raya
[email protected]
949-288-5701
Gary Ulaner (PRINCIPAL_INVESTIGATOR)
Mayo Clinic - RochesterRochesterMinnesota55905-
Uni Of TX MD Anderson Cancer CntrHoustonTexas77030
Alyson Clayborn
[email protected]
713-792-2921
Senthilkumar Damodaran (PRINCIPAL_INVESTIGATOR)
University Of WisconsinMadisonWisconsin53792
Hannah Piersee Tadlock
[email protected]
+1 608 262 7202
Kari Wisinski (PRINCIPAL_INVESTIGATOR)

Find similar trials in Los Angeles, CA

By condition
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By specialty
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By research site
UCLA Medical Center· Los Angeles, CAHoag Memorial Hospital Presbyterian· Newport Beach, CAMayo Clinic - Rochester· Rochester, MNUni Of TX MD Anderson Cancer Cntr· Houston, TXUniversity Of Wisconsin· Madison, WI

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