Trial Title:
Study of RYZ101 in Combination With SoC in Subjects With SSTR+ ES-SCLC
NCT ID:
NCT05595460
Condition:
SCLC,Extensive Stage
Conditions: Official terms:
Small Cell Lung Carcinoma
Carboplatin
Etoposide
Atezolizumab
Conditions: Keywords:
actinium
alpha-emitter
SSTR+ ES-SCLC
SCLC
ES-SCLC
RYZ101
225Ac
225Ac-DOTATATE
targeted radiotherapy
atezolizumab
carboplatin
etoposide
radiopharmaceutical
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
RYZ101 Dose Level 1
Description:
Dose Level 1
Arm group label:
RYZ101 + SoC
Intervention type:
Drug
Intervention name:
RYZ101 Dose Level 2
Description:
Dose Level 2
Arm group label:
RYZ101 + SoC
Intervention type:
Drug
Intervention name:
RYZ101 Dose Level 3
Description:
Dose Level 3
Arm group label:
RYZ101 + SoC
Intervention type:
Drug
Intervention name:
RYZ101 Dose Level -1
Description:
Dose Level -1
Arm group label:
RYZ101 + SoC
Intervention type:
Drug
Intervention name:
Atezolizumab
Description:
Atezolizumab
Arm group label:
RYZ101 + SoC
Intervention type:
Drug
Intervention name:
Carboplatin
Description:
Carboplatin
Arm group label:
RYZ101 + SoC
Intervention type:
Drug
Intervention name:
Etoposide
Description:
Etoposide
Arm group label:
RYZ101 + SoC
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.
Criteria for eligibility:
Criteria:
Subjects must meet all the following criteria for enrollment in the study:
Cytologically or histologically confirmed proven ES-SCLC and is untreated or received ≤1
cycle of platinum-etoposide and PD-L1 inhibitor therapy (including SoC administered
during screening, if applicable).
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
Eastern Cooperative Oncology Group (ECOG) PS 0-1.
Life expectancy of at least 12 weeks.
SSTR-PET positive
Sufficient renal function
Adequate hematologic function
Adequate hepatic function
Woman of childbearing potential (WOCBP) must have a negative serum pregnancy test within
48 hours prior to the first dose of study drug and agree to use barrier contraception and
a second form of highly effective contraception or total abstinence while receiving study
drug and for 6 months following their last dose of RYZ101/SoC.
Sexually active male subjects must use a condom during intercourse while receiving study
drug and for 3 months after the last dose of the study drug and should not father a child
during this period. If sexual partners are WOCBP must also agree to use a second form of
highly effective contraception or total abstinence while receiving study drug and for 3
months following their last dose of RYZ101/SoC.
Able to read and/or understand the details of the study and provide written informed
consent prior to any study-specific assessments and procedures commence
Subjects who meet any of the following criteria will be excluded from the study:
Prior exposure to immune-mediated therapy excluding anticancer vaccines and excluding 1
cycle of SoC therapy administered during the screening period.
Known active or suspected autoimmune disease, including paraneoplastic syndromes of
autoimmune nature.
Prior PRRT
Known hypersensitivity to 225Ac, 68Ga, 64Cu, octreotate, or any of the excipients of
DOTATATE imaging agents.
Known hypersensitivity to Chinese hamster ovary cell products or to any component of the
atezolizumab formulation.
History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or
fusion proteins.
History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis
obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active
pneumonitis on screening chest CT scan.
Severe infection within 4 weeks prior to initiation of study treatment
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.
Any contraindication to receive carboplatin or etoposide. Radiotherapy to the chest prior
to systemic therapy or planned consolidation chest radiation therapy or prior external
beam radiation therapy to more than 25% of the bone marrow.
Major surgery within 4 weeks prior to first dose of study drug.
Prior participation in any interventional clinical study within 30 days prior to first
dose of study drug.
Significant cardiovascular disease, such as New York Heart Association (NYHA) Class ≥II
heart failure. QT interval corrected for heart rate using Fridericia's formula (QTcF)
>470 ms.
Resistant hypertension, defined as uncontrolled blood pressure (BP) >140/90 mmHg while on
optimal doses of at least 3 antihypertensive medications with 1 being a diuretic (Whelton
et al. 2018). Subjects with baseline hypertension may be eligible after initiation of
antihypertensive therapy.
Have a history of primary malignancy within the past 3 years other than (1) SCLC, (2)
adequately treated carcinoma in situ or non-melanoma carcinoma of the skin, (3) any other
curatively treated malignancy that is not expected to require treatment for recurrence
during participation in the study, or (4) an untreated cancer on active surveillance that
may not affect survival status for ≥3 years based on clinician assessment/statement and
with Medical Monitor approval.
Previously treated central nervous system (CNS) metastases who have not recovered from
acute side effects of radiotherapy
Active infections such as tuberculosis, hepatitis B or C virus or HIV, or are current
treatment with antiviral therapy for HBV.
Pregnancy or lactation.
Unable or unwilling to comply with the requirements of the study protocol
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Research Facility
Address:
City:
Los Angeles
Zip:
90024
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Contact
Facility:
Name:
Research Facility
Address:
City:
San Francisco
Zip:
94158
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Contact Gee
Facility:
Name:
Research Facility
Address:
City:
Jacksonville
Zip:
32224
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Contact
Facility:
Name:
Research Facility
Address:
City:
Orlando
Zip:
32806
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Contact
Facility:
Name:
Research Facility
Address:
City:
Grand Rapids
Zip:
49503
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Contact
Facility:
Name:
Research Facility
Address:
City:
Troy
Zip:
48098
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Contact
Facility:
Name:
Research Facility
Address:
City:
Rochester
Zip:
55905
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Contact
Facility:
Name:
Research Facility
Address:
City:
Omaha
Zip:
68130
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Contact
Facility:
Name:
Research Facility
Address:
City:
Houston
Zip:
77090
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Contact
Facility:
Name:
Research Facility
Address:
City:
Salt Lake City
Zip:
84112
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Contact
Facility:
Name:
Research Facility
Address:
City:
San Juan
Zip:
00935
Country:
Puerto Rico
Status:
Recruiting
Contact:
Last name:
Site Contact
Start date:
October 10, 2022
Completion date:
December 2026
Lead sponsor:
Agency:
RayzeBio, Inc.
Agency class:
Industry
Source:
RayzeBio, Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05595460
