Study of RYZ101 in Combination With SoC in Subjects With SSTR+ ES-SCLC
Trial Parameters
Brief Summary
This study aims to determine the safety, preliminary antitumor activity, and pharmacokinetics (PK) of RYZ101 in combination with standard of care (SoC) therapy consisting of carboplatin + etoposide + atezolizumab in untreated subjects with somatostatin receptor expressing (SSTR+) ES-SCLC.
Eligibility Criteria
INCLUSION CRITERIA * Age of at least 18 years at the time of signing the informed consent. * Cytologically or histologically confirmed ES-SCLC (American Joint Committee on Cancer \[AJCC\] 8th edition) and is untreated or received ≤1 cycle of platinum-etoposide and PD-L1 inhibitor therapy. It is acceptable to omit the first dose of PD-L1 inhibitor therapy due to logistical reasons if receiving SoC during or prior to the start of the screening period. * Subject is a candidate for therapy with SoC which includes: * Carboplatin for a maximum of 4 cycles * Etoposide for a maximum of 4 cycles * Atezolizumab * At least 1SSTR-PET imaging-positive measurable site of disease (according to RECIST v1.1) and ≥50% of RECIST v1.1 measurable metastatic lesions must be SSTR-imaging positive. * Adequate hematologic, renal and hepatic function EXCLUSION CRITERIA * Prior exposure to immune-mediated therapy, * Known active or suspected autoimmune disease or any condition requiring systemic treatment with i