RecruitingPhase 1NCT05595460

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

Phase 1b Single Arm, Open-label Trial of RYZ101 in Combination With Carboplatin + Etoposide + Atezolizumab in Subjects With Somatostatin Receptor Expressing (SSTR+) Extensive Stage Small Cell Lung Cancer (ES-SCLC)


Sponsor

RayzeBio, Inc.

Enrollment

49 participants

Start Date

Oct 10, 2022

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing RYZ101, a targeted radioactive drug that seeks out tumors expressing a protein called SSTR (somatostatin receptor), in combination with standard chemotherapy for people with extensive-stage small cell lung cancer (SCLC). SCLC is an aggressive lung cancer, and new approaches are urgently needed. **You may be eligible if...** - You are 18 years or older - You have confirmed extensive-stage small cell lung cancer (meaning it has spread beyond one lung) - You are untreated or have only received up to 1 cycle of standard chemotherapy - You are a candidate for standard platinum-etoposide chemotherapy plus a PD-L1 immunotherapy drug **You may NOT be eligible if...** - Your tumor does not express the SSTR receptor (tested by imaging or biopsy) - You have other conditions that make combination therapy unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGRYZ101 Dose Level 1

Dose Level 1

DRUGRYZ101 Dose Level 2

Dose Level 2

DRUGRYZ101 Dose Level 3

Dose Level 3

DRUGRYZ101 Dose Level -1

Dose Level -1

DRUGAtezolizumab

Atezolizumab

DRUGCarboplatin

Carboplatin

DRUGEtoposide

Etoposide


Locations(15)

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

View Full Details on ClinicalTrials.gov

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NCT05595460


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