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Actively Recruiting
Study of RYZ101 in Combination With SoC in Subjects With SSTR+ ES-SCLC
About
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.
Primary Purpose
Study Type
Phase
Eligibility
Gender
Healthy Volunteers
Minimum Age
Maximum Age
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.
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Study Stats
Protocol No.
23-001276
Category
Lung Cancer
Principal Investigator
Contact
Location
- UCLA Santa Monica
- UCLA Westwood