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NCT05595460 | RECRUITING | SCLC,Extensive Stage

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

RayzeBio, Inc.

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.

Condition or disease

SCLC,Extensive Stage

Intervention/treatment

RYZ101 Dose Level 1

RYZ101 Dose Level 2

RYZ101 Dose Level 3

RYZ101 Dose Level -1

Atezolizumab

Carboplatin

Etoposide

Phase

PHASE1

Study Type : INTERVENTIONAL
Estimated Enrollment : 49 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : 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)
Actual Study Start Date : 2022-10-10
Estimated Primary Completion Date : 2027-06
Estimated Study Completion Date : 2029-03

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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.
    • Study of RYZ101 in Combination With SoC in Subjects With SSTR+ ES-SCLC

    Location Details

    NCT05595460

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    How to Participate

    Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

    Locations

    RECRUITING

    United States, California

    Research Facility

    Los Angeles, California, United States, 90024

    RECRUITING

    United States, California

    Research Facility

    San Francisco, California, United States, 94158

    RECRUITING

    United States, Florida

    Research Facility

    Jacksonville, Florida, United States, 32224

    RECRUITING

    United States, Florida

    Research Facility

    Miami, Florida, United States, 33136

    RECRUITING

    United States, Florida

    Research Facility

    Orlando, Florida, United States, 32806

    RECRUITING

    United States, Iowa

    Research Facility

    Iowa City, Iowa, United States, 52242

    RECRUITING

    United States, Kentucky

    Reserach Facility

    Lexington, Kentucky, United States, 40536

    RECRUITING

    United States, Road cancer

    Research Facility

    Grand Rapids, Road cancer, United States, 49503

    WITHDRAWN

    United States, Road cancer

    Research Facility

    Troy, Road cancer, United States, 48098

    RECRUITING

    United States, Minnesota

    Research Facility

    Rochester, Minnesota, United States, 55905

    RECRUITING

    United States, Missouri

    Research Facility

    Saint Louis, Missouri, United States, 63130

    RECRUITING

    United States, Nebraska

    Research Facility

    Omaha, Nebraska, United States, 68130

    WITHDRAWN

    United States, Texas

    Research Facility

    Houston, Texas, United States, 77090

    RECRUITING

    United States, Utah

    Research Facility

    Salt Lake City, Utah, United States, 84112

    RECRUITING

    Puerto Rico,

    Research Facility

    San Juan, Puerto Rico, 00935