Phase 1/2Completed
[177Lu]-NeoB in Patients With Advanced Solid Tumors and With [68Ga]-neoB Lesion Uptake (NeoRay)
A Phase I/IIa Open-label, Multi-center Study to Evaluate the Safety, Tolerabiity, 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)
- Sponsor
- Advanced Accelerator Applications (Industry)
- Enrollment
- 35 enrolled
- Conditions
- Neoplasms
- Interventions
- [177Lu]-NeoB; [68Ga]-NeoB; LCZ696
- Ages
- adults, older adults
- Registry
- NCT03872778, CTIS2023-507170-41-00
Full record on ClinicalTrials.gov
From the registry
First in Human (FIH) study to characterize the safety, tolerability, pharmacokinetics (PK), distribution, 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.
Primary outcomes
- Phase I: Incidence of dose limiting toxicities (DLTs) of [177Lu]-NeoB
- Phase I: Determination of Maximum Tolerated Dose (MTD)/ Recommended phase two dose (RP2D) of [177Lu]-NeoB
- Phase IIa (Cohorts A, B and C): Individual clinical responses assessed by Response Evaluation Criteria In Solid Tumors (RECIST v1.1)
- Phase IIa (Cohort E): Absorbed radiation doses of [177Lu]-NeoB in organs and tumor lesions
History
Last registry update
Study completion
Primary completion
Started
Registered