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-GB
• 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: 2019-01-24
• Last Update Posted: 1 February 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 71

Inclusion Criteria

1. Signed informed consent must be obtained prior to participation in the study.
2. Adult patients with advanced solid tumors known to overexpress GRPR.
3. [68Ga]-NeoB tumor lesion uptake on PET/CT or PET/MRI scan during Selection phase (= 50% of lesions detectable with dose CT or MRI acquired together with the [68Ga]-NeoB PET have to be [68Ga]-NeoB positive)
4. At least one measurable lesion per RECIST 1.1/RANO with a [68Ga]-NeoB uptake.
5. Patients for whom no standard therapy is available, tolerated or appropriate.
6. Presence of at least one detacble tumor lesion confirmed with CT or MRI acquired together with the [68Ga]-NeoB PET.
7. Patient Eastern Cooperative Oncology Group (ECOG) performance status = 2.
8. 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 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 41

Exclusion Criteria

1. Creatinine clearance (calculated using Cockcroft-Gault formula, or measured) < 60 mL/min or serum creatinine >1.5 x ULN.
2. Platelet count of < 75 x 109/L .
3. Absolute neutrophil count (ANC) < 1.0 x 109/L.
4. Hemoglobin < 9 g/dL.
5. 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.
6. Total bilirubin > 1.5 x ULN, except for patients with documented Gilbert’s syndrome who are eligible if total bilirubin = 3 x ULN.
7. Serum amylase and/or lipase > 1.5 x ULN.
8. Known or expected hypersensitivity to [177Lu]-NeoB, [68Ga]-NeoB or any of their excipients.
9. Impaired cardiac function or clinically significant cardiac disease
10. Patients with diabetes mellitus requiring insulin treatment and/or with clinical signs or with fasting plasma glucose >160 mg/dL (8.9 mmol/L).
11. Patients with history of or ongoing acute or chronic pancreatitis.
12. Prior administration of a radiopharmaceutical with therapeutic intent within a period corresponding to 10 half-lives of the radionuclide used in such radiopharmaceutical.
13. Prior External Beam Radiation Therapy (EBRT) to more than 25% of the bone marrow.
14. [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.
15. Patients who have changed the dose of systemic steroid therapy within less than 2 weeks prior to [68Ga]-NeoB (IMP2) administration or patients for whom steroid dose increase is anticipated during the study.
16. 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.
17. History of somatic or psychiatric disease/condition that may interfere with the objectives and assessments of the study.
18. 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 [177Lu]-NeoB 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.
19. Pregnant or breast-feeding women
20. 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 th

Study & Design

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