The anti-tumor effect was further enhanced when RYZ101 was combined with carboplatin and etoposide at clinically relevant doses. In summary, RYZ101 is a highly potent, alpha-emitting radiopharmaceutical agent, and preclinical data demonstrate the potential of RYZ101 for the treatment of patients with SSTR-positive cancers.
Initial data suggest promising efficacy. Part 2 (phase 3) is enrolling and will compare RYZ101 at 10.2MBq q8w for 4 cycles with standard of care in pts with advanced SSTR2+ GEP-NETs progressing following prior 177Lu-labeled SSAs.
In summary, RYZ101 is a first-in-class, highly potent, -emitting radiopharmaceutical therapy being developed for the treatment of SSTR+ solid tumors. Preclinical data demonstrate the potential of RYZ101 for the treatment of patients with SSTR+ SCLC. A Phase 1b trial of RYZ101 in combination with atezolizumab, carboplatin, and etoposide is underway in patients with SSTR+ ES-SCLC (NCT05595460).
RYZ101 was well tolerated at 120 kBq/kg, which was declared the RP3D. Part 2 (Phase 3) will commence after Part 1 and will compare RYZ101 at the RP3D with standard of care in pts with advanced SSTR2+ GEP-NETs with disease progression following prior 177Lu-labeled SSAs. Clinical trial information: NCT05477576.
In summary, RYZ101 is a first-in-class, highly potent, α-emitting radiopharmaceutical therapy being developed for the treatment of SSTR+ solid tumors. Preclinical data demonstrate the potential of RYZ101 for the treatment of patients with SSTR+ SCLC.
In Part 2, ~210 patients will be randomized (1:1) to receive RYZ101 RP3D every 8 weeks for up to 4 cycles or investigator’s choice SoC (everolimus, sunitinib, or high-dose long-acting SSA); crossover to RYZ101 is permitted. Part 2 will commence after Part 1 at ~60 sites in North America, South America, Europe, and Asia. CONCLUSIONS No conclusions; TiP abstract.