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

Launched by RAYZEBIO, INC. · Oct 24, 2022

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment called RYZ101, which is being tested alongside standard therapies for patients with extensive stage small cell lung cancer (ES-SCLC) who have not been previously treated. The main goals of the study are to see how safe RYZ101 is, whether it helps fight the cancer, and how the body processes the medication. Participants will receive standard chemotherapy drugs, which include carboplatin, etoposide, and atezolizumab, along with RYZ101.

To join the study, patients need to have a confirmed diagnosis of ES-SCLC and should not have received significant prior treatment, among other health criteria. Eligible participants may expect regular check-ups to monitor their health and response to the treatment. It's also important for women of childbearing age to confirm they are not pregnant and to use effective contraception during the study. This trial is currently recruiting participants, and those interested should discuss with their healthcare provider to see if they qualify.

Gender

ALL

Eligibility 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.