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

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.

Description

Eligibility

Age range

18–100 years

Sex

All

Healthy volunteers

No

Interventions

• Drug
  [68Ga]Ga-NeoB

  \[68Ga\]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.

• Drug
  [177Lu]Lu-NeoB

  Study participants will receive \[177Lu\]Lu-NeoB once every cycle

• Drug
  Ribociclib

  600 mg once daily (OD) days 1 to 21 every 28 days

• Drug
  Fulvestrant

  500 mg at Cycle 1 Day 1, Cycle 1 Day 15, Cycle 2 Day 1 and every 28 days thereafter

• Other
  Goserelin

  For pre/peri-menopausal women and men only.

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