[177Lu]-NeoB in Patients With Advanced Solid Tumors and With [68Ga]-neoB Lesion Uptake

Completed · Phase 1/Phase 2

Conditions studied: Neoplasms

In brief

First in Human (FIH) study to characterize the safety, tolerability, pharmacokinetics (PK), distribution, radiation dosimetry, and anti-tumor activity of \[177Lu\]-NeoB in patients with advanced solid tumors known to overexpress GRPR and with \[68Ga\]-NeoB lesion uptake.

Key facts

Study ID

NCT03872778

Run by

Advanced Accelerator Applications

People needed

35

Starts

2019-07-24

Expected to finish

2025-11-27

Last updated by the study team

2026-07-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Signed informed consent prior to participation
• Adult patients with advanced solid tumors known to overexpress GRPR
• [68Ga]-NeoB tumor lesion uptake on PET/CT or PET/MRI scan at screening visit (>50% of lesions detected with conventional imaging are identified as well by [68Ga]-NeoB uptake)
• At least one measurable lesion per RECIST 1.1/RANO with a [68Ga]-NeoB uptake
• Patients for whom no standard therapy is available, tolerated or appropriate
• Presence of at least one tumor lesion confirmed with functional or structural imaging (PET, SPECT, CT, MRI, bone scan) within 2 months prior to study entry
• Patient Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
• Life expectancy more than 6 months.

You may not qualify if…

• Creatinine clearance (calculated using Cockcroft-Gault formula, or measured) < 60 mL/min or serum creatinine > 1.5 x ULN.
• Platelet count of < 75 x 10e9/L
• Absolute neutrophil count (ANC) < 1.0 x 10e9/L
• Hemoglobin < 9 g/dL
• alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 3 x upper limit of normal (ULN) if no demonstrable liver metastases of > 5 x ULN in the presence of liver metastases
• Total bilirubin > 1.5 ULN, except for patients with documented Gilbert's syndrome who are eligible if total bilirubin ≤ x ULN
• Serum amylase and/or lipase > 1.5 ULN
• Known or expected hypersensitivity to [177Lu]-NeoB, [68Ga]-NeoB or any of their excipients
• Impaired cardiac function or clinically significant cardiac disease, including any of the following:
• Clinically significant and/or uncontrolled heart disease such as congestive heart failure requiring treatment (New York Heart Association (NHYA) grade ≥2), uncontrolled arterial hypertension or clinically significant arrhythmia
• LVEF < 50% as determined by echocardiogram (ECHO)
• QTcF > 470 msec for females and QTcF >450 msec for males on screening electrocardiogram (ECG) or congenital long QT syndrome
• Acute myocardial infarction or unstable angina pectoris < 3 months prior to study entry
• Patients with diabetes mellitus requiring insulin treatment and/or with clinical signs or with fasting plasma glucose > 160 mg/dL (8.9 mmol/L)
• Patients with history of or ongoing acute or chronic pancreatitis
• Prior administration of a radiopharmaceutical with therapeutic intent within a period corresponding to 10 half-lives of the radionuclide used in such radiopharmaceutical
• Prior External Beam Radiation Therapy (EBRT) to more than 25% of the bone marrow
• Patients with a bone scan showing an excessive skeletal radiopharmaceutical uptake with absent or faint activity in soft tissues and the genitourinary tract due to diffuse bone/bone marrow metastases in bone scan also called a "superscan"
• Prior treatment with Radium=223
• Patients who have changed the dose of systemic steroid therapy within less than 2 weeks prior to study entry or patients for whom steroid dose increase is anticipated during the study.
• Patients who have received prior systemic anti-cancer treatment within the following time frames:
• Cyclical chemotherapy within a period that is shorter than the cycle length used for that treatment (e.g. 6 weeks for nitrosourea, mitomycin-C) prior to starting study treatment
• Biologic therapy (e.g. antibodies), continuous or intermittent small molecule therapeutics, or any other investigational agents within a period which is ≤ 5T1/2 or ≤ 4 weeks (whichever is longer) prior to study entry
• History of somatic or psychiatric disease/condition that may interfere with the objectives and assessments of the study.
• Malignant disease, other than that being treated in this study. Exceptions to this exclusion include the following: malignancies that were treated curatively and have not recurred within 2 years prior to study treatment; completely resected basal cell and squamous cell skin cancers; any malignancy considered to be indolent and that has never required therapy; and completely resected carcinoma in situ of any type

Where it is running

• City of Hope — Duarte, California, United States
• Stanford University — Stanford, California, United States
• John Hopkins University — Baltimore, Maryland, United States
• Oregon Health & Science University — Portland, Oregon, United States
• Pittsburgh University — Pittsburgh, Pennsylvania, United States
• MD Anderson Cancer Center — Houston, Texas, United States
• Medical University of Innsbruck — Innsbruck, Austria
• CHU de Grenoble — La Tronche, France
• Erasmus MC — Rotterdam, Netherlands
• Vall d'Hebron Institute of Oncology — Barcelona, Spain
• Addenbroke's hospital — Cambridge, United Kingdom

Full record on ClinicalTrials.gov

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