A Phase I/IIa Open-label, Multi-center Study to Evaluate the Safety, Tolerability, Whole-body Distribution, Radiation Dosimetry and Anti-tumor Activity of [177Lu]-NeoB Administered in Patients With Advanced Solid Tumors Known to Overexpress Gastrin-releasing Peptide Receptor (GRPR)

Status: Recruiting
Location: See all (10) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY

The purpose of this first-in-human (FIH) study of [177Lu]-NeoB is to characterize the safety, tolerability, pharmacokinetics (PK) as well as the distribution and 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: No
View:

• Signed informed consent must be obtained prior to participation in the study.

• Adult patients (age >= 18 years old) with any of the following advanced or metastatic solid tumors:

• For Phase I: breast cancer, lung cancer, prostate cancer, GIST, GBM

• For Phase IIa:

• Cohort A: Breast cancer with histology as follows: HR-positive with ER > 10% of nuclei stain, HER-2 negative as assessed on the primary diagnosis

• Cohort B: Prostate cancer

• Cohort C: GIST

• Cohort D: patients affected by any metastatic solid tumor type suspected to overexpress GRPR, and with moderate impaired renal function defined as creatinine clearance (calculated using the Cockcroft-Gault formula, or measured) ≥ 30mL/min and < 60mL/min

• At least one measurable lesion 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.

• Patients for whom no standard therapy is available, tolerated or appropriate in both Phase I and Phase IIa. Specifically in the Phase IIa breast cancer cohort, patients need to have completed at least two prior treatments of endocrine therapy (including CDk4/6i) and at least one prior chemotherapy (unless contraindicated) in the metastatic setting.

• Patient Eastern Cooperative Oncology Group (ECOG) performance status =< 2.

Locations
United States
California
City of Hope
Recruiting
Duarte
Stanford University
Recruiting
Stanford
Maryland
John Hopkins University
Recruiting
Baltimore
North Carolina
Duke University
Withdrawn
Durham
Oregon
Oregon Health & Science University
Recruiting
Portland
Other Locations
Austria
Medical University of Innsbruck
Recruiting
Innsbruck
Germany
University of Essen
Not yet recruiting
Essen
Netherlands
Erasmus MC
Recruiting
Rotterdam
Spain
Vall d'Hebron Institute of Oncology
Not yet recruiting
Barcelona
United Kingdom
Addenbroke's hospital
Not yet recruiting
Cambridge
Contact Information
Primary
Novartis Pharmaceuticals
Novartis.email@novartis.com
1-888-669-6682
Backup
Novartis Pharmaceuticals
Novartis.email@novartis.com
+41613241111
Time Frame
Start Date: July 24, 2019
Estimated Completion Date: December 31, 2024
Participants
Target number of participants: 86
Treatments
Experimental: Phase I Cohort I
[68 Ga]-NeoB: 50 micrograms/dose at screening~[177Lu]-NeoB: 50 mCi (1.85 GBq) cycle 1, 60% Estimated Cumulative Dose (ECD) for cycles 2-4, q6w
Experimental: Phase I Cohort II
[68 Ga]-NeoB: 50 micrograms/dose at screening~[177Lu]-NeoB: 60% ECD for 3 cycles (q6w)
Experimental: Phase I Cohort III
[68 Ga]-NeoB: 50 micrograms/dose at screening~[177Lu]-NeoB: 80% ECD for 3 cycles (q6w)
Experimental: Phase I Cohort IV
[68 Ga]-NeoB: 50 micrograms/dose at screening~[177Lu]-NeoB: 100% ECD for 3 cycles (q6w)
Experimental: Phase I Cohort V
[68 Ga]-NeoB: 50 micrograms/dose at screening~[177Lu]-NeoB: 120% ECD for 3 cycles (q6w)
Experimental: Phase I Cohort VI
[68 Ga]-NeoB: 50 micrograms/dose at screening~[177Lu]-NeoB: 100% ECD for 2 cycles (q6w)
Experimental: Phase I Cohort VII
[68 Ga]-NeoB: 50 micrograms/dose at screening~[177Lu]-NeoB: 120% ECD for 2 cycles (q6w)
Experimental: Phase IIa
[68 Ga]-NeoB: 50 micrograms/dose at screening~[177Lu]-NeoB: dose TBD based on Cohorts I-VI, 3 cycles q6w
Authors
Salvador Borges-Neto, Lilja Solnes, Andrei Iagaru, Herrmann, van der Veldt, Erick Mittra, Aloj, Irene Virgolini, Jeffrey YC Wong
Sponsors
Leads: Advanced Accelerator Applications

This content was sourced from clinicaltrials.gov

Similar Clinical Trials