Study of RYZ101 in Combination With SoC in Subjects With SSTR+ ES-SCLC

Running, not enrolling · Phase 1

Conditions studied: SCLC,Extensive Stage

In brief

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.

Key facts

Study ID

NCT05595460

Run by

RayzeBio, Inc.

People needed

21

Starts

2022-10-10

Expected to finish

2027-07-01

Last updated by the study team

2026-04-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Research Facility — Los Angeles, California, United States
• Research Facility — San Francisco, California, United States
• Research Facility — Jacksonville, Florida, United States
• Research Facility — Miami, Florida, United States
• Research Facility — Orlando, Florida, United States
• Research Facility — Iowa City, Iowa, United States
• Reserach Facility — Lexington, Kentucky, United States
• Research Facility — Grand Rapids, Michigan, United States
• Research Facility — Rochester, Minnesota, United States
• Research Facility — St Louis, Missouri, United States
• Research Facility — Omaha, Nebraska, United States
• Research Facility — Salt Lake City, Utah, United States
• Research Facility — San Juan, Puerto Rico, Puerto Rico

Full record on ClinicalTrials.gov

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