Radiopharmaceuticals for Cancer Diagnosis and Therapy: New Targets, New Therapies-Alpha-Emitters, Novel Targets.
Neil K Taunk, Freddy E Escorcia, Jason S Lewis...
https://pubmed.ncbi.nlm.nih.gov/38753757Actively Recruiting
Phase 1
Age: 18Years - 100Years
All Genders
ID05870579
A Phase Ib Study to Find the Recommended Dose of [177Lu]Lu-NeoB with Ribociclib and Fulvestrant in Adults With ER+, HER2-, GRPR+ Advanced Breast Cancer Who Relapsed or Progressed After Endocrine Therapy
Led by Novartis Pharmaceuticals · Updated on 2026-06-08
48
Participants Needed
25
Research Sites
274 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the combination of [177Lu]Lu-NeoB with ribociclib and fulvestrant in adults with advanced breast cancer that is estrogen receptor positive, HER2 negative, and gastrin releasing peptide receptor positive. This trial focuses on participants who have experienced early relapse after endocrine therapy or whose disease has progressed on endocrine therapy combined with a CDK4/6 inhibitor. The goal is to find the recommended dose of [177Lu]Lu-NeoB when used with these other treatments. The trial consists of a dose escalation phase testing four planned doses of [177Lu]Lu-NeoB (100, 150, 200, and 250 millicurie) in small groups, followed by a backfill phase to gather additional safety and preliminary effectiveness data at an established dose. Participants receive [177Lu]Lu-NeoB once every 28-day cycle for six cycles, along with daily ribociclib for the first 21 days of each cycle and fulvestrant on specific days starting from cycle 1 day 1. Pre- and perimenopausal women and men also get goserelin each cycle. Imaging with [68Ga]Ga-NeoB is done during screening, possibly at cycle 2 day 15, and after treatment to assess disease. Participants attend clinic visits every 28 days for treatment, safety checks, and dosimetry assessments, with additional visits early in cycles 1, 2, 3, and 5. Tumor evaluations occur every 8 weeks up to 18 months, then every 12 weeks until 36 months, and further as needed. Safety follow-up lasts 8 weeks after treatment ends, followed by long-term monitoring every 12 to 24 weeks until 5 years from enrollment or until withdrawal, death, or loss to follow-up. Researchers measure dose-limiting toxicities, adverse events, dose changes, drug levels in blood, tumor responses, and survival outcomes.
CONDITIONS
Brief Title
[177Lu]Lu-NeoB in Combination With Ribociclib and Fulvestrant in Participants With ER+, HER2- and GRPR+ Advanced Breast Cancer
Who Can Participate
Age: 18Years - 100Years
All Genders
Eligibility Criteria
You may qualify if you...
- Adult female or male aged 18 years or older at consent
- Confirmed diagnosis of estrogen receptor positive breast cancer with ER >10%
- HER2 negative breast cancer confirmed by specific lab tests
- Advanced breast cancer that is recurrent or metastatic
- Relapsed within 12 months after (neo)adjuvant endocrine therapy without advanced treatment, OR relapsed after 12 months and progressed after one endocrine therapy line (except fulvestrant), OR advanced at diagnosis with progression after one endocrine therapy line (except fulvestrant)
- At least one measurable lesion showing uptake on PET/CT or PET/MRI
- Adequate bone marrow and organ function
- ECG with QTcF < 450 msec and heart rate 50-90 bpm
- ECOG performance status 0 or 1
You will not qualify if you...
- More than one prior advanced/metastatic treatment or prior fulvestrant treatment
- Previous ribociclib dose reduction due to safety reasons
- Relapse or progression within 6 months of CDK4/6 inhibitor therapy
- Symptomatic visceral disease or disease making ribociclib plus endocrine therapy unsuitable
- CNS involvement unless stable and meeting specific criteria
- Current use of warfarin or Coumadin anticoagulants
- Diagnosis of inflammatory breast cancer
- Child Pugh score B or C
- History or current significant cardiac disease or ECG abnormalities
- Known allergy to study drugs or excipients
- Recent radiopharmaceutical treatment or radiation therapy not resolved
- Recent systemic corticosteroid use without full recovery
- Recent acute pancreatitis
- Use of medications or substances that interfere with study drugs or imaging
- Use of NEP inhibitors preventing dosimetry imaging assessments
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial. During screening, participants will receive an imaging agent ([68Ga]Ga-NeoB) to help localize lesions.
1 visit (in-person)
Treatment
Duration - 6 cycles of 28 days each
Participants receive study treatment consisting of [177Lu]Lu-NeoB on day 1 of each 28-day cycle for up to 6 cycles, along with daily ribociclib (days 1 to 21) and fulvestrant at specified days. Additional imaging with [68Ga]Ga-NeoB may occur during treatment. Safety and tumor assessments are performed regularly.
Visits approximately every 28 days on day 1 of each cycle, plus additional visits on C1D2, C1D3, C1D8, C1D15, C2D15, C3D3, and C5D3; tumor assessments every 8 weeks until month 18, then every 12 weeks until month 36
Follow-up
Duration - Up to 5 years from enrollment
After treatment ends, participants are followed for safety for 8 weeks, then followed every 12 weeks until month 36 and every 24 weeks thereafter until month 60 or until death, lost to follow-up, or withdrawal of consent.
Follow-up visits every 12 weeks until month 36, then every 24 weeks until month 60
Trial Site Locations
Total: 25 locations
1
UCLA Jonsson Comp Cancer Center
Los Angeles, California, United States, 90095
Active, Not Recruiting
2
Hoag Memorial Hospital Presbyterian
Newport Beach, California, United States, 92663
Actively Recruiting
3
University of Kansas Medical Center
Westwood, Kansas, United States, 66205
Actively Recruiting
4
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Active, Not Recruiting
5
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Active, Not Recruiting
6
Utah Intermountain Medical Center
Murray, Utah, United States, 84107
Active, Not Recruiting
7
Novartis Investigative Site
Guangzhou, China, 510060
Withdrawn
8
Novartis Investigative Site
Shanghai, China, 200032
Active, Not Recruiting
9
Novartis Investigative Site
Tianjin, China, 300300
Withdrawn
10
Novartis Investigative Site
Saint-Cloud, Hauts De Seine, France, 92210
Active, Not Recruiting
11
Novartis Investigative Site
Bordeaux, France, 33076
Completed
12
Novartis Investigative Site
Clermont-Ferrand, France, 63011
Active, Not Recruiting
13
Novartis Investigative Site
Saint-Herblain, France, 44805
Active, Not Recruiting
14
Novartis Investigative Site
Strasbourg, France, F 67085
Active, Not Recruiting
15
Novartis Investigative Site
Cologne, North Rhine-Westphalia, Germany, 50937
Active, Not Recruiting
16
Novartis Investigative Site
Erlangen, Germany, 91054
Withdrawn
17
Novartis Investigative Site
Essen, Germany, 45147
Active, Not Recruiting
18
Novartis Investigative Site
München, Germany, 80377
Active, Not Recruiting
19
Novartis Investigative Site
Gliwice, Poland, 44 101
Actively Recruiting
20
Novartis Investigative Site
Porto, Portugal, 4200-072
Active, Not Recruiting
21
Novartis Investigative Site
L'Hospitalet de Llobregat, Barcelona, Spain, 08907
Active, Not Recruiting
22
Novartis Investigative Site
Barcelona, Spain, 08035
Withdrawn
23
Novartis Investigative Site
Barcelona, Spain, 08036
Active, Not Recruiting
24
Novartis Investigative Site
Madrid, Spain, 28034
Active, Not Recruiting
25
Novartis Investigative Site
Madrid, Spain, 28040
Active, Not Recruiting
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Research Team
N
Novartis Pharmaceuticals
N
Novartis Pharmaceuticals
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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