A Phase Ib Dose Finding Study Assessing Safety and Activity of [177Lu]Lu-NeoB in Combination With Ribociclib and Fulvestrant in Participants With Estrogen Receptor Positive, Human Epidermal Growth Factor Receptor-2 Negative and Gastrin Releasing Peptide Receptor Positive 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

Status: Recruiting
Location: See all (25) locations...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 100
Healthy Volunteers: f
View:

• Adult female or male \>= 18 years of age at the time of informed consent

• Histologically and/or cytologically confirmed diagnosis of estrogen-receptor positive with ER \>10% (regardless of progesterone receptor (PgR) expression) breast cancer by local laboratory testing (based on the most recently analyzed tissue sample)

• HER2 negative breast cancer defined as a negative in situ hybridization test or an immunohistochemistry (IHC) status of 0, 1+ or 2+. If IHC is 2+, a negative in situ hybridization (e.g. fluorescence in situ hybridization (FISH), chromogenic in situ hybridization (CISH), or silver in situ hybridization (SISH)) test is required by local laboratory testing (based on the most recently analyzed tissue sample)

• Participant has advanced (loco regionally recurrent not amenable to curative therapy (e.g. surgery and/or radiotherapy) or metastatic) breast cancer

• Participants may be:

⁃ relapsed with documented evidence of relapse on or within 12 months from completion of (neo)adjuvant endocrine therapy (+/- CDK4/6 inhibitor) with no treatment for advanced disease OR

⁃ relapsed with documented evidence of relapse more than 12 months from completion of (neo)adjuvant endocrine therapy and then subsequently progressed with documented evidence of progression after one line of endocrine therapy (except fulvestrant) (+/- CDK4/6 inhibitor) for advanced disease OR

⁃ advanced breast cancer at diagnosis that progressed with documented evidence of progression after one line of endocrine therapy (except fulvestrant) (+/- CDK4/6 inhibitor) Note: Participant who relapsed with documented evidence of relapse on/or within 12 months from completion of (neo)adjuvant endocrine therapy and then subsequently progressed with documented evidence of progression after one line of endocrine therapy (with either an antiestrogen or an aromatase inhibitor) for advanced disease will NOT be included in the study. At least one target lesion (i.e., a measurable lesion as per RECIST 1.1) in the baseline stand-alone CT or MRI, showing \[68Ga\]Ga-NeoB uptake on PET/CT or PET/MRI scoring 2 or higher, based on the Visual Scoring Scale.

∙ Adequate bone marrow and organ function as defined by the laboratory values.

‣ Standard 12-lead ECG values defined as the mean of the triplicate ECGs and assessed locally:

‣ QT interval corrected by Fridericia's formula (QTcF) interval at screening \< 450 msec

‣ Mean resting heart rate 50-90 bpm (determined from the ECG)

‣ Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

Locations
United States
California
UCLA Jonsson Comp Cancer Center
RECRUITING
Los Angeles
Hoag Memorial Hospital Presbyterian
RECRUITING
Newport Beach
Kansas
University of Kansas Medical Center
RECRUITING
Westwood
Pennsylvania
University of Pennsylvania
RECRUITING
Philadelphia
Texas
MD Anderson Cancer Center
RECRUITING
Houston
Utah
Utah Intermountain Medical Center
RECRUITING
Murray
Other Locations
China
Novartis Investigative Site
RECRUITING
Guangzhou
Novartis Investigative Site
RECRUITING
Shanghai
Novartis Investigative Site
RECRUITING
Tianjin
France
Novartis Investigative Site
RECRUITING
Bordeaux
Novartis Investigative Site
RECRUITING
Clermont-ferrand
Novartis Investigative Site
RECRUITING
Saint-cloud
Novartis Investigative Site
RECRUITING
Saint-herblain
Novartis Investigative Site
RECRUITING
Strasbourg
Germany
Novartis Investigative Site
RECRUITING
Cologne
Novartis Investigative Site
RECRUITING
Erlangen
Novartis Investigative Site
RECRUITING
Essen
Novartis Investigative Site
RECRUITING
München
Poland
Novartis Investigative Site
RECRUITING
Gliwice
Portugal
Novartis Investigative Site
RECRUITING
Porto
Spain
Novartis Investigative Site
RECRUITING
Barcelona
Novartis Investigative Site
RECRUITING
Barcelona
Novartis Investigative Site
RECRUITING
L'hospitalet De Llobregat
Novartis Investigative Site
RECRUITING
Madrid
Novartis Investigative Site
RECRUITING
Madrid
Contact Information
Primary
Novartis Pharmaceuticals
novartis.email@novartis.com
1-888-669-6682
Backup
Novartis Pharmaceuticals
novartis.email@novartis.com
+41613241111
Time Frame
Start Date: 2023-11-13
Estimated Completion Date: 2032-01-26
Participants
Target number of participants: 48
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Novartis Pharmaceuticals

This content was sourced from clinicaltrials.gov

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