eoRay - Phase I/IIa trial of [177Lu]-NeoB in patients with advanced solid tumors and with [68Ga]-NeoB lesion uptake.

Phase 1

• Conditions: Solid tumors known to overexpress GRPR and with [68Ga]-NeoB lesion uptake; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2018-004727-37-ES
• Lead Sponsor: Advanced Accelerator Applications International SA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-07-02
• Last Update Posted: 8 October 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 86

Inclusion Criteria

1. Signed informed consent must be obtained prior to participation in the study.
2. Adult patients (age = 18 years old) with any of the following advanced or metastatic solid tumors: breast cancer, lung cancer, prostate cancer, GIST, GBM.
3. At least one measurable lesion as per RECIST 1.1, RANO (applicable for GBM only) criteria detected on the low-dose CT/MRI (for GBM MRI only) acquired together with the [68Ga]-NeoB PET. The same identified measurable lesion shows [68Ga]-NeoB uptake on PET/CT or PET/MRI. If the only matching lesion is located in the bone, the patient will still be eligible.
4. Patients for whom no standard therapy is available, tolerated or appropriate.
5. Patient Eastern Cooperative Oncology Group (ECOG) performance status = 2.
6. Life expectancy more than 6 months.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 35
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 51

Exclusion Criteria

1. Patients who have not had resolution, except where otherwise stated in the inclusion/ exclusion criteria, of all clinically significant toxic effects of prior systemic cancer therapy, surgery, or radiotherapy to Grade =1 (except for alopecia).
2. Creatinine clearance (calculated using Cockcroft-Gault formula, or measured) < 60 mL/min or serum creatinine > 1.5 x ULN
3. Platelet count of < 75 x 109/L
4. Absolute neutrophil count (ANC) < 1.0 x 109/L.
5. Hemoglobin < 9 g/dL
6. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 3 x upper limit of normal (ULN) if no demonstrable liver metastases or > 5 x ULN in the presence of liver metastases
7. Total bilirubin > 1.5 x ULN, except for patients with documented Gilbert’s syndrome who are eligible if total bilirubin = 3 x ULN
8. Serum amylase and/or lipase > 1.5 x ULN
9. Known or expected hypersensitivity to [177Lu]-NeoB, [68Ga]-NeoB or any of their excipients.
10. 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 (NYHA 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 [177Lu]-NeoB (IMP1) administration.
11. Patients with diabetes mellitus not stable under current treatment as judged by the investigator or with hyperglycemia = CTCAE Grade 2
12. Patients with history of or ongoing acute or chronic pancreatitis.
13. Concurrent bladder outflow obstruction or unmanageable urinary incontinence.
14. Administration of a radiopharmaceutical with therapeutic intent within a period corresponding to 10 half-lives of the radionuclide used prior to injection of [68Ga]-NeoB (IMP2).
15. Prior External Beam Radiation Therapy (EBRT) to more than 25% of the bone marrow.
16. [223Ra]-therapy within the context of diffuse bone or bone-marrow involvement (i.e. superscan” defined as bone scintigraphy in which there is excessive skeletal radioisotope uptake [>20 bone lesions] in relation to soft tissues along with absent or faint activity in the genitourinary tract due to diffuse bone/ bone marrow metastases).
17. Patients who have changed the dose of systemic steroid therapy within less than 2 weeks prior to [177Lu]-NeoB (IMP1) administration or patients for whom steroid dose increase is anticipated during the study.
18. 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 [177Lu]-NeoB treatment
• 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
19. History of somatic or psychiatric disease/condition that may interfere with the objectives and assessments of the study.
20. 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified