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Phase I/II Study of [177Lu]Lu-NeoB with Capecitabine for Metastatic Breast Cancer

This study is for people with metastatic breast cancer that is ER-positive, HER2-negative, and GRPR-positive, and has progressed after previous endocrine therapy with a CDK4/6 inhibitor. It's testing a new treatment called [177Lu]Lu-NeoB, which is a radioligand therapy drug, in combination with capecitabine, a chemotherapy drug. Researchers want to find the best dose of [177Lu]Lu-NeoB when given with capecitabine, and then see how well this combination works against the cancer. To join, you must be between 18 and 100 years old, and have ER+ breast cancer. The study will enroll about 20 participants.

Study design
This is a Phase I/II interventional study, meaning it tests a new treatment in people. It aims to enroll 20 participants to find the right dose and then evaluate how well the treatment works.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
You would be monitored for side effects from the start of treatment until 56 days after your last dose, and for dose modifications up to approximately 31 months. Overall follow-up for side effects could last up to about 33 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06247995

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.

Active, Not Recruiting
PHASE1Ages 18+InterventionalTreatment
Novartis Pharmaceuticals
~20 participants
Updated 2026-08-20 on ClinicalTrials.gov
What's tested:[68Ga]Ga-NeoB[177Lu]Lu-NeoBCapecitabine

At a glance

Recruiting sites
0 of 23 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Phase I: Incidence and severity of dose limiting toxicities (DLTs)
Measured over 42 days after the first administration of [177Lu]Lu-NeoB
+8 more outcomes measured

Conditions

Breast Cancer

Explore related trials

Breast CarcinomaGRPR Gene

Where it's being run

23 sites across 17 states
France3
California2
Germany2
South Korea2
Spain2
Minnesota1
Texas1
Wisconsin1

Study leadership

  • Novartis Pharmaceuticals · STUDY_DIRECTOR · Novartis Pharmaceuticals

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

in case of confirmed presence of deleterious or suspected deleterious germline BRCA1 or BRCA2 mutation, the participant may also have received a PARP inhibitor-based therapy.
In case of HER2-low breast cancer (IHC 1+ or IHC 2+ with ISH negative as per ASCO-CAP guidelines Wolff et al 2023), the participant may also have received trastuzumab deruxtecan \[Enhertu®\]).
If there is liver disease involvement (in the absence of lung involvement), in ≥ 50% of all CT measurable liver lesions (RECIST 1.1)
If there is lung disease involvement (in the absence of liver involvement), in ≥ 50% of all CT measurable lung lesions (RECIST 1.1)
Participants with both liver and lung disease involvement must show \[68Ga\]Ga-NeoB uptake above the liver in ≥ 50% of all CT measurable lesions either in liver or lung (RECIST 1.1) and in at least one measurable lesion in the remaining organ (lung or liver) 9a. Participants with central nervous system (CNS) involvement are eligible provided that they meet ALL the following criteria:
At least 2 weeks from prior therapy completion (including radiation and/or surgery) to initiation of the study treatment
Clinically stable CNS tumor at the time of screening
Participant is not receiving steroids and/or anti-epileptic medications for brain metastases at the time of initiation of the radioligand study treatment 10. Participant has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Absolute neutrophil count ≥ 1.5 × 109/L
Platelets ≥ 100 × 109/L
Hemoglobin ≥ 9.0 g/dL
International Normalized Ratio (INR) ≤1.5
Estimated glomerular filtration rate (eGFR) ≥ 60 ml/min/1.73m2 using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation
Total bilirubin (TBIL) \< 1.5 × ULN (any elevated bilirubin should be asymptomatic at enrollment) except for participants with Gilbert's syndrome who may only be included if the total bilirubin is ≤ 3.0 × ULN or direct bilirubin ≤ 1.5 × ULN
In absence of liver metastases, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \< 2.5 × ULN. If the participant has liver metastases, the participant will be eligible for the study if ALT and AST \< 5 X ULN.
Serum lipase ≤ 1.5 × ULN Note: no platelet transfusion, packed red blood cell transfusion, or G-CSF will be allowed during the screening phase after ICF signature
Participant must have the following laboratory values within normal limits or corrected to within normal limits with supplements before the first dose of study medication:
Potassium
Magnesium
Total Calcium (corrected for serum albumin) 12. Participant must be able to swallow capecitabine tablets. 13. Participant must be able to communicate with the investigator and comply with the requirements of the study procedures.
Prior surgical bilateral oophorectomy (with or without hysterectomy)
Age ≥ 60 years
Age \< 60 years and ≥ 12 months of natural (spontaneous) amenorrhea in the absence of chemotherapy, tamoxifen, toremifene, or ovarian suppression with serum Follicle-Stimulating Hormone (FSH) and estradiol in the postmenopausal range per local normal range.
Aged \< 60 years: chemotherapy-induced amenorrhea for ≥ 12 months with serial measurements of FSH and estradiol in post-menopausal ranges (NCCN V4 2023).
Aged \< 60 years: on tamoxifen with serial measurements of FSH and estradiol in post-menopausal ranges Note: Ovarian radiation or treatment with a gonadotropin releasing hormone agonist (GnRHas e.g. goserelin acetate) is not permitted for induction of ovarian suppression in the Phase I part.
Patient had last menstrual period within the last 12 months OR
If on tamoxifen or toremifene within the past 14 days, FSH and estradiol in pre-menopausal ranges on serial measurements OR
In case of therapy induced amenorrhea, FSH and estradiol in pre-menopausal ranges on serial measurements Note: Peri-menopausal status is defined as neither pre-menopausal nor post-menopausal (see definition above)
Male participants, regardless of their need of GnRHas while on study treatment.

Exclusion

Documented myocardial infarction (MI), angina pectoris, cardiomyopathy, symptomatic pericarditis, or coronary artery bypass graft (CABG) within 6 months prior to study entry
Clinically significant cardiac arrhythmias (e.g., ventricular tachycardia), complete left bundle branch block, high-grade atrioventricular (AV) block (e.g., bifascicular block, Mobitz type II and third-degree AV block)
Long QT syndrome or family history of idiopathic sudden death or congenital long QT syndrome, or any of the following:
Risk factors for TdP including uncorrected hypocalcemia, hypokalemia or hypomagnesemia, history of cardiac failure, or history of clinically significant/symptomatic bradycardia
Inability to determine the Fridericia QT correction formula (QTcF) interval
Resting QTcF ≥450 msec (male) or ≥460 msec (female) at screening as per standard 12-lead ECG values defined as the mean of the triplicate ECGs and assessed locally
Left Ventricular Ejection Fraction (LVEF) \< 50% as determined by echocardiogram (ECHO) or MUGA.
Uncontrolled hypertension defined by a Systolic Blood Pressure (SBP) ≥ 160 mmHg and/or Diastolic Blood Pressure (DBP) ≥ 100 mm Hg, with or without anti-hypertensive medication.
remain abstinent (refrain from sexual intercourse) or
use a condom, while taking study treatment and for at least 4 months after the last administration of \[177Lu\]Lu-NeoB, or 3 months after the last dose of capecitabine (or as per locally prescribing information) whichever is longer, in addition to the highly effective method used by the partner who is a female of child-bearing potential.
Pregnant or breast-feeding women
Women of childbearing potential, defined as all women physiologically capable of becoming pregnant, are not allowed to participate in this study UNLESS they are using highly effective methods of contraception throughout the study and for up to 7 months after the last administration of \[177Lu\]Lu-NeoB or 6 months after the last dose of capecitabine (or as per locally prescribing information) whichever is longer. Highly effective contraception methods include:
Total abstinence (when this is in line with the preferred and usual lifestyle of the subject). Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.
Bilateral oophorectomy with or without hysterectomy, total hysterectomy, or bilateral salpingectomy at least six weeks before taking study treatment. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment are they not considered to be of childbearing potential.
Bilateral tubal occlusion, Bilateral tubal ligation (at least six weeks before taking study treatment)..
Sterilization (vasectomy) of male partner(s) of the female participant at least 6 months prior to screening provided partner(s) has(have) received medical assessment of the surgical success.
Placement of an intrauterine device (IUD) and concurrent use of barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository.

What this trial measures

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

    A DLT is defined as an adverse event or abnormal laboratory value assessed as unrelated to disease, disease progression, inter-current illness/injury, or concomitant medications that occurs within the DLT period from C1D1 of treatment with \[177Lu\]Lu-NeoB and capecitabine. The National Cancer Institute (NCI) CTCAE version 5.0 will be used for all grading.

  • Phase I: Incidence and severity of adverse events and serious adverse events for 177-Lu-NeoB in combination with capecitabineFrom start of study treatment until 56 days after the last dose of study treatment, assessed up to approximately 33 months

    The distribution of adverse events for 177-Lu-NeoB in combination with capecitabine will be done via the analysis of frequencies for Adverse Event (AEs) and Serious Adverse Event (SAEs) through the monitoring of relevant clinical and laboratory safety parameters.

  • Phase I: Dose modifications for [177Lu]Lu-NeoB in combination with capecitabineFrom start of study treatment until the last dose of study treatment, assessed up to approximately 31 months

    Dose modifications (dose interruptions, dose discontinuations and reductions) for \[177Lu\]Lu-NeoB in combination with capecitabine will be assessed and summarized using descriptive statistics.

  • Phase II: Objective Response Rate (ORR)From date of randomization until date of progression, death or further antineoplastic therapy, whichever comes first, assessed up to approximately 88 months

    Objective Response Rate (ORR) with confirmed response is defined as the proportion of participants with Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR), as per local review and according to RECIST 1.1.

  • Phase II: Clinical Benefit Rate (CBR)From date of randomization until date of progression, death or further antineoplastic therapy, whichever comes first, assessed up to approximately 88 months

    Clinical Benefit Rate (CBR) with confirmed response is defined as the proportion of participants with Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR), or maintaining an overall response of Stable Disease (SD) for at least 24 weeks. CR, PR, and SD are defined as per local review according to RECIST 1.1.

  • Phase II: Time to Response (TTR)From date of randomization until first documented evidence of CR or PR (the response prior to confirmation), assessed up to approximately 88 months

    Time to response is the time from the date of randomization to the first documented response (Complete Response (CR) or Partial Response (PR), which must be confirmed subsequently) as per local review and according to RECIST 1.1.

  • Phase II: Duration of Response (DoR)From first documented evidence of CR or PR (the response prior to confirmation) until time of documented disease progression or death due to any cause, whichever comes first, assessed up to approximately 88 months

    Duration of Overall Response (DoR) applies only to participants whose best overall response is confirmed CR or confirmed PR according to RECIST 1.1. The start date is the date of first documented confirmed response (CR or PR) and the end date is the date defined as first documented progression or death due to underlying cancer.

  • Phase II: Progression Free Survival (PFS)From the date of first dose to the date of confirmed progression or death due to any cause, whichever comes first, assessed up to approximately 88 months

    Progression Free Survival (PFS) is defined as the time from the date of first dose of \[177Lu\]Lu-NeoB to the date of confirmed progression or death due to any cause. PFS will be assessed via local review according to RECIST 1.1.

  • Phase II: Overall Survival (OS)From the date of first dose until date of death from any cause, assessed up to approximately 88 months

    Overall Survival (OS) is defined as the time from date of first dose of \[177Lu\]Lu-NeoB to date of death due to any cause.