Testing RYZ101 with standard treatment for advanced small cell lung cancer
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)
This study is testing if adding RYZ101 to the usual treatment for advanced small cell lung cancer can be safe and effective for patients who have not yet received treatment.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 49 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | RayzeBio, Inc. Industry-sponsored |
| Drugs / interventions | Atezolizumab, radiation |
| Locations | 15 sites (Los Angeles, California and 14 other locations) |
| Trial ID | NCT05595460 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and preliminary effectiveness of RYZ101 when combined with standard treatment, which includes carboplatin, etoposide, and atezolizumab, in patients with untreated extensive stage small cell lung cancer (ES-SCLC) that express somatostatin receptors. Participants must have measurable disease confirmed by imaging and meet specific health criteria. The study aims to gather data on the pharmacokinetics of RYZ101 alongside the standard of care.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with untreated extensive stage small cell lung cancer that expresses somatostatin receptors.
Not a fit: Patients who have previously received immune-mediated therapy or have active autoimmune diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced small cell lung cancer.
How similar studies have performed: While this approach is novel, similar studies targeting SSTR+ cancers have shown promise, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Los Angeles, California and 14 other locations
- Research Facility — Los Angeles, California, United States (Recruiting)
- Research Facility — San Francisco, California, United States (Recruiting)
- Research Facility — Jacksonville, Florida, United States (Recruiting)
- Research Facility — Miami, Florida, United States (Recruiting)
- Research Facility — Orlando, Florida, United States (Recruiting)
- Research Facility — Iowa City, Iowa, United States (Recruiting)
- Reserach Facility — Lexington, Kentucky, United States (Recruiting)
- Research Facility — Grand Rapids, Michigan, United States (Recruiting)
- Research Facility — Troy, Michigan, United States (Withdrawn)
- Research Facility — Rochester, Minnesota, United States (Recruiting)
- Research Facility — Saint Louis, Missouri, United States (Recruiting)
- Research Facility — Omaha, Nebraska, United States (Recruiting)
- Research Facility — Houston, Texas, United States (Withdrawn)
- Research Facility — Salt Lake City, Utah, United States (Recruiting)
- Research Facility — San Juan, Puerto Rico (Recruiting)
Study contacts
- Study coordinator: RayzeBio Clinical Trials
- Email: clinicaltrials@rayzebio.com
- Phone: 619-657-0302
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.