Cancer Type: Gastrointestinal Tumor
Study Type: Treatment
Phase: Phase I/II
Principal Investigator: Strosberg, Jonathan
Phase 1b/3 z=Global, Randomized, Controlled, Open-Label Trial Comparing Treatment with RYZ101 to Standard of Care (SoC) Therapy in Subjects with Inoperable, Advanced, Somatostatin Receptor Expressing (SSTR+), Well-Differentiated Gastro-Enteropancreatic Neuroendocrine Tumors (GEP-NETs) that have Progressed Following Prior 177Lulabelled Somatostatin Analogue (177Lu-SSA) Therapy (ACTION-1).
This study aims to determine the safety, pharmacokinetics (PK) and recommended Phase 3 dose (RP3D) of RYZ101 in Part 1, and the safety, efficacy, and PK of RYZ101 compared with investigator-selected standard of care (SoC) therapy in Part 2 in subjects with inoperable, advanced, well-differentiated, somatostatin receptor expressing (SSTR+) gastroenteropancreatic neuroendocrine tumors (GEP-NETs) that have progressed following treatment with Lutetium 177-labelled somatostatin analogue (177Lu-SSA) therapy, such as 177Lu-DOTATATE or 177Lu-DOTATOC (177Lu-DOTATATE/TOC), or 177Lu-high affinity [HA]-DOTATATE.
Part 1 * To determine the RP3D of RYZ101 * To assess the safety and tolerability of RYZ101 in subjects with SSTR+ GEP-NET that has progressed following treatment with 177Lu-DOTATATE/177Lu-DOTATOC Part 2 * To determine if treatment with RYZ101, compared to SoC therapy, improves centrally confirmed PFS in study subjects. * To characterize the safety and tolerability of RYZ101 in study subjects
Chemotherapy (NOS); Therapy (NOS)
Amino acids (); Granisetron (); Lanreotide (); Ondansetron (); RYZ101 (); Sunitinib (); Zofran (Ondansetron); everolimus (RAD001); octreotide LAR ()
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