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Ribociclib / [177Lu]Lu-NeoB / [68Ga]Ga-NeoB · Phase 1 Trial
ClinicalTrials.gov · August 20, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a Phase 1 dose-escalation registry record for [177Lu]Lu-NeoB combined with ribociclib and fulvestrant in GRPR+ ER+/HER2− advanced breast cancer. The study is active but not recruiting, with enrollment complete (28 participants). No efficacy or safety results are posted in this registry record; the primary objectives are dose-limiting toxicity assessment over 28 days and adverse event monitoring.
Phase 1, Interventional, Single Group, Open label, Treatment purpose. Breast Cancer; age from 18 Years; to 100 Years. Intervention: Arm 1. n = 28. 13 sites across 7 countries.
This is a Phase 1 dose-escalation registry record for [177Lu]Lu-NeoB combined with ribociclib and fulvestrant in GRPR+ ER+/HER2− advanced breast cancer. The study is active but not recruiting, with enrollment complete (28 participants). No efficacy or safety results are posted in this registry record; the primary objectives are dose-limiting toxicity assessment over 28 days and adverse event monitoring.
Phase 1 design focuses on safety and dose escalation, not clinical efficacy.
Clinicians should recognize this as an ongoing Phase 1 study establishing the recommended dose of [177Lu]Lu-NeoB in combination therapy for a GRPR-positive breast cancer population. Results are not yet available in the registry and efficacy data are not expected from a Phase 1 record.
Phase 1 dose-escalation study with safety endpoints only; no efficacy results reported in registry record. Designed to establish recommended dose of [177Lu]Lu-NeoB in combination therapy.
As stated by the source record.
Quoted from the source exactly as published.
Clinicians should recognize this as an ongoing Phase 1 study establishing the recommended dose of [177Lu]Lu-NeoB in combination therapy for a GRPR-positive breast cancer population. Results are not yet available in the registry and efficacy data are not expected from a Phase 1 record.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT05870579). This is a study registration, not published results. Lead sponsor: Novartis Pharmaceuticals. Recruitment status: ACTIVE_NOT_RECRUITING. Phase: PHASE1. Study type: INTERVENTIONAL. Enrollment: 28 participants (ACTUAL). Conditions: Breast Cancer. Interventions: DRUG: [68Ga]Ga-NeoB; DRUG: [177Lu]Lu-NeoB; DRUG: Ribociclib; DRUG: Fulvestrant; OTHER: Goserelin. Primary outcome measures: Incidence and nature of DLTs during the DLT observation period , 28 days after the first administration of [177Lu]Lu-NeoB; Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) , From date of enrollment till 8 weeks after end of Treatment, assessed up to approximately 60 months; Incidence of dose interruptions, discontinuation and dose reductions , From date of enrollment till 8 weeks after end of Treatment, assessed up to approximately 60 months. Brief 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.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.