Study of RYZ101 in Combination With SoC in Subjects With SSTR+ ES-SCLC
NCT ID: NCT05595460
Last Updated: 2025-08-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
49 participants
INTERVENTIONAL
2022-10-10
2029-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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RYZ101 + SoC
RYZ101 Dose Level 1
Dose Level 1
RYZ101 Dose Level 2
Dose Level 2
RYZ101 Dose Level 3
Dose Level 3
RYZ101 Dose Level -1
Dose Level -1
Atezolizumab
Atezolizumab
Carboplatin
Carboplatin
Etoposide
Etoposide
Interventions
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RYZ101 Dose Level 1
Dose Level 1
RYZ101 Dose Level 2
Dose Level 2
RYZ101 Dose Level 3
Dose Level 3
RYZ101 Dose Level -1
Dose Level -1
Atezolizumab
Atezolizumab
Carboplatin
Carboplatin
Etoposide
Etoposide
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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RayzeBio, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Petrus De Jong, MD
Role: STUDY_DIRECTOR
RayzeBio, Inc.
Locations
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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
Troy, Michigan, United States
Research Facility
Rochester, Minnesota, United States
Research Facility
St Louis, Missouri, United States
Research Facility
Omaha, Nebraska, United States
Research Facility
Houston, Texas, United States
Research Facility
Salt Lake City, Utah, United States
Research Facility
San Juan, Puerto Rico, Puerto Rico
Countries
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Central Contacts
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Facility Contacts
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Site Contact
Role: primary
Site Contact Gee
Role: primary
Site Contact
Role: primary
Site Contact
Role: primary
Site Contact
Role: primary
Site Contact
Role: primary
Site Contact
Role: primary
Site Contact
Role: primary
Site Contact
Role: primary
Site Contact
Role: primary
Site Contact
Role: primary
Site Contact
Role: primary
Site Contact
Role: primary
Other Identifiers
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RYZ101-101
Identifier Type: -
Identifier Source: org_study_id
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