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 not accepting patients for this trial.

Lead Sponsor:

Advanced Accelerator Applications

Stanford Investigator(s):

Intervention(s):

  • Drug: [177Lu]-NeoB
  • Drug: [68Ga]-NeoB

Phase:

Phase 1/Phase 2

Eligibility


Inclusion Criteria:

   - 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.

Exclusion Criteria:

   - 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

   - 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

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Andrea Otte
650-736-4183
Recruiting