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Clinical Trials in the USA / NCT05595460
Active, not recruiting Phase 1

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

NCT05595460 · tracked via the Priya Life Science USA tracker
Sponsor
RayzeBio, Inc.
Phase
Phase 1
Started
2022-10-10
Last updated
2026-04-13

Condition(s) studied

SCLC,Extensive Stage

Investigational drug(s) / intervention(s)

RYZ101 Dose Level 1 →RYZ101 Dose Level 2 →RYZ101 Dose Level 3 →RYZ101 Dose Level -1Atezolizumab →Carboplatin →Etoposide →

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

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (13)

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

On this site

📄 Tecentriq (atezolizumab) drug profile →

More RayzeBio, Inc. trials in the USA

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05595460 on ClinicalTrials.gov ↗ ← All trials in the USA