NCT05595460Active, not recruitingPhase 1
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)
Source: ClinicalTrials.gov · Last updated 13 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 21 (actual)
- First submitted
- 16 Sept 2022
- Start date
- 10 Oct 2022
- Primary completion date
- Jul 2027
- Lead sponsor
- RayzeBio, Inc.
- Diseases
- Lung cancer
- NCT number
- NCT05595460
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 21
- From 10 Oct 2022 to the primary completion date, Jul 2027
- 13 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- 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.
- Subjects with previously treated central nervous system (CNS) metastases who have not recovered from acute side effects of radiotherapy.
Other illness
- History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis. Note: History of radiation pneumonitis is permitted.
- Significant cardiovascular disease and/or resistant hypertension
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (13)
Sites in registry order. Save your city in your profile to sort them by distance.
This page is information, not medical advice. Discuss any trial with your doctor.