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Study of RYZ101 in Combination With SoC in Subjects With SSTR+ ES-SCLC
Trial Status: active
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.
Inclusion 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 immunosuppressive medications within 14 days prior to first dose of
study drug
- History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis
obliterans), drug-induced pneumonitis, or idiopathic pneumonitis. Note: History of
radiation pneumonitis is permitted.
- Severe infection within 4 weeks and/or treatment with therapeutic oral or i.v.
antibiotics within 2 weeks prior to initiation of study treatment.
- Prior allogeneic stem cell or solid organ transplantation.
- Treatment with a live, attenuated vaccine within 4 weeks prior to initiation of
study treatment, or anticipation of need for such a vaccine during atezolizumab
treatment or within 5 months after the final dose of atezolizumab.
- Radiotherapy to the chest prior to systemic therapy or planned consolidation chest
radiation therapy. Radiation therapy outside of the chest for palliative care is
allowed but must be completed >2 weeks prior to first dose of study drug.
- Significant cardiovascular disease and/or resistant hypertension
- Subjects with previously treated central nervous system (CNS) metastases who have
not recovered from acute side effects of radiotherapy.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05595460.