Trial Search Results
[177Lu]-NeoB in Patients With Advanced Solid Tumors and With [68Ga]-NeoB Lesion Uptake
The purpose of the study is to establish whether the product NeoB, can be used, without any high risks and safety issues for the participant's health, in a theragnostic approach combining selection and therapy of the participant's advanced solid tumors characterized by an overexpression of Gastrin-Releasing Peptide Receptor (GRPR), a receptor normally present on some of your body cells.
Stanford is currently accepting patients for this trial.
Advanced Accelerator Applications
- Drug: [177Lu]-NeoB
- Drug: [68Ga]-NeoB
Phase 1/Phase 2
- 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
- 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 low-dose CT or MRI acquired
together with the [68Ga]-NeoB PET
- Patient Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
- Life expectancy more than 6 months.
- 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
- 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
- Impaired cardiac function or clinically significant cardiac disease, including any of
- 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
- 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
- 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
- Biologic therapy (e.g. antibodies), continuous or intermittent small molecule
therapeutics, or any other investigational agents within a period which is ≤ 5
T1/2 or ≤ 4 weeks (whichever is shorter) prior to starting [177Lu]-NeoB treatment
- 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
- pregnant or breast-feeding women
- women of child-bearing 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 6 months after
study drug discontinuation. Highly effective contraception methods include:
- Total abstinence
- Male or female sterilization
- Combination of any two of the following (a+b or a+c or b+c)
1. Use of oral, injected, or implanted hormonal methods of contraception. In
case of use of oral contraception, women should be stable on the same pill
for a minimum of 3 months before taking study treatment.
2. Placement of an intrauterine device (IUD) or intrauterine system (IUS).
3. Barrier methods of contraception: condom or occlusive cap (diaphragm or
cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal
suppository. Post-menopausal women are allowed to participate in this study.
Women are considered post-menopausal and not of child bearing potential if
they have had 12 months of natural (spontaneous) amenorrhea with an
appropriate clinical profile (e.g. age appropriate, history of vasomotor
symptoms) or six months of spontaneous amenorrhea with serum
Follicle-Stimulating Hormone (FSH) levels > 40 mIU/mL [for US only: and
estradiol < 20 pg/mL] or have had surgical bilateral oophorectomy (with or
without hysterectomy) or tubal ligation at least six weeks prior to
screening. In the case of oophorectomy alone, only when the reproductive
status of the woman has been confirmed by follow-up hormone level assessment
is she considered not of child bearing potential. Sexually active males must
use a condom during intercourse while taking the drug and for 6 months after
stopping treatment and should not father a child in this period. A condom is
required to be used also by vasectomized men in order to prevent delivery of
the drug via seminal fluid.
Ages Eligible for Study
18 Years - N/A
Genders Eligible for Study