Study of RYZ101 in Combination With SoC in Subjects With SSTR+ ES-SCLC
- Conditions
- SCLC,Extensive Stage
- Registration Number
- NCT05595460
- Lead Sponsor
- RayzeBio, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Subjects must meet all the following criteria for enrollment in the study:<br><br>Cytologically or histologically confirmed proven ES-SCLC and is untreated or received =1<br>cycle of platinum-etoposide and PD-L1 inhibitor therapy (including SoC administered<br>during screening, if applicable).<br><br>Subject is a candidate for therapy with SoC which includes:<br><br>Carboplatin for a maximum of 4 cycles<br><br>Etoposide for a maximum of 4 cycles<br><br>Atezolizumab<br><br>Eastern Cooperative Oncology Group (ECOG) PS 0-1.<br><br>Life expectancy of at least 12 weeks.<br><br>SSTR-PET positive<br><br>Sufficient renal function<br><br>Adequate hematologic function<br><br>Adequate hepatic function<br><br>Woman of childbearing potential (WOCBP) must have a negative serum pregnancy test within<br>48 hours prior to the first dose of study drug and agree to use barrier contraception and<br>a second form of highly effective contraception or total abstinence while receiving study<br>drug and for 6 months following their last dose of RYZ101/SoC.<br><br>Sexually active male subjects must use a condom during intercourse while receiving study<br>drug and for 3 months after the last dose of the study drug and should not father a child<br>during this period. If sexual partners are WOCBP must also agree to use a second form of<br>highly effective contraception or total abstinence while receiving study drug and for 3<br>months following their last dose of RYZ101/SoC.<br><br>Able to read and/or understand the details of the study and provide written informed<br>consent prior to any study-specific assessments and procedures commence<br><br>Subjects who meet any of the following criteria will be excluded from the study:<br><br>Prior exposure to immune-mediated therapy excluding anticancer vaccines and excluding 1<br>cycle of SoC therapy administered during the screening period.<br><br>Known active or suspected autoimmune disease, including paraneoplastic syndromes of<br>autoimmune nature.<br><br>Prior PRRT<br><br>Known hypersensitivity to 225Ac, 68Ga, 64Cu, octreotate, or any of the excipients of<br>DOTATATE imaging agents.<br><br>Known hypersensitivity to Chinese hamster ovary cell products or to any component of the<br>atezolizumab formulation.<br><br>History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or<br>fusion proteins.<br><br>History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis<br>obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active<br>pneumonitis on screening chest CT scan.<br><br>Severe infection within 4 weeks prior to initiation of study treatment<br><br>Treatment with therapeutic oral or i.v. antibiotics within 2 weeks prior to initiation of<br>study treatment<br><br>Prior allogeneic stem cell or solid organ transplantation<br><br>Treatment with a live, attenuated vaccine within 4 weeks prior to initiation of study<br>treatment, or anticipation of need for such a vaccine during atezolizumab treatment or<br>within 5 months after the final dose of atezolizumab.<br><br>Any contraindication to receive carboplatin or etoposide. Radiotherapy to the chest prior<br>to systemic therapy or planned consolidation chest radiation therapy or prior external<br>beam radiation therapy to more than 25% of the bone marrow.<br><br>Major surgery within 4 weeks prior to first dose of study drug.<br><br>Prior participation in any interventional clinical study within 30 days prior to first<br>dose of study drug.<br><br>Significant cardiovascular disease, such as New York Heart Association (NYHA) Class =II<br>heart failure. QT interval corrected for heart rate using Fridericia's formula (QTcF)<br>>470 ms.<br><br>Resistant hypertension, defined as uncontrolled blood pressure (BP) >140/90 mmHg while on<br>optimal doses of at least 3 antihypertensive medications with 1 being a diuretic (Whelton<br>et al. 2018). Subjects with baseline hypertension may be eligible after initiation of<br>antihypertensive therapy.<br><br>Have a history of primary malignancy within the past 3 years other than (1) SCLC, (2)<br>adequately treated carcinoma in situ or non-melanoma carcinoma of the skin, (3) any other<br>curatively treated malignancy that is not expected to require treatment for recurrence<br>during participation in the study, or (4) an untreated cancer on active surveillance that<br>may not affect survival status for =3 years based on clinician assessment/statement and<br>with Medical Monitor approval.<br><br>Previously treated central nervous system (CNS) metastases who have not recovered from<br>acute side effects of radiotherapy<br><br>Active infections such as tuberculosis, hepatitis B or C virus or HIV, or are current<br>treatment with antiviral therapy for HBV.<br><br>Pregnancy or lactation.<br><br>Unable or unwilling to comply with the requirements of the study protocol
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method RP2D;Safety and tolerability of RYZ101 in combination with SoC
- Secondary Outcome Measures
Name Time Method