SCLC,Extensive StagePhase 1NCT05595460
Study of RYZ101 in Combination With SoC in Subjects With SSTR+ ES-SCLC
A Phase 1 study testing RYZ101 Dose Level 1, RYZ101 Dose Level 2 and RYZ101 Dose Level 3 in people with SCLC,Extensive Stage, run by RayzeBio, Inc. at 13 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- SCLC,Extensive Stage
- What is being tested?
- RYZ101 Dose Level 1, RYZ101 Dose Level 2 and RYZ101 Dose Level 3
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 13 sitesin 2 countries
- Study dates
- 10 Oct 2022to Jul 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
13 sites in 2 countries.
13 sites in 2 countries
United States12 sites
Research Facility
Grand Rapids, Michigan, 49503
Research Facility
Iowa City, Iowa, 52242
Research Facility
Jacksonville, Florida, 32224
Reserach Facility
Lexington, Kentucky, 40536
Research Facility
Los Angeles, California, 90024
Research Facility
Miami, Florida, 33136
Research Facility
Omaha, Nebraska, 68130
Research Facility
Orlando, Florida, 32806
Research Facility
Rochester, Minnesota, 55905
Research Facility
Salt Lake City, Utah, 84112
Research Facility
San Francisco, California, 94158
Research Facility
St Louis, Missouri, 63130
About this study
Official title: 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 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.
- Conditions
- SCLC,Extensive Stage
- Being tested
- RYZ101 Dose Level 1, RYZ101 Dose Level 2, RYZ101 Dose Level 3, RYZ101 Dose Level -1, Atezolizumab
- Keywords
- actinium, alpha-emitter, SSTR+ ES-SCLC, SCLC, ES-SCLC, RYZ101, 225Ac, 225Ac-DOTATATE, targeted radiotherapy, atezolizumab, carboplatin, etoposide, radiopharmaceutical
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RYZ101 Dose Level 1Drug
Dose Level 1
RYZ101 Dose Level 2Drug
Dose Level 2
RYZ101 Dose Level 3Drug
Dose Level 3
RYZ101 Dose Level -1Drug
Dose Level -1
AtezolizumabDrug
Atezolizumab
CarboplatinDrug
Carboplatin
EtoposideDrug
Etoposide
| Study group | Role | What they receive |
|---|---|---|
| RYZ101 + SoC | Experimental | Not described Receives: Drug: RYZ101 Dose Level 1; Drug: RYZ101 Dose Level 2; Drug: RYZ101 Dose Level 3; Drug: RYZ101 Dose Level -1; Drug: Atezolizumab; Drug: Carboplatin; Drug: Etoposide |
What is being measured
The primary outcome is the main question the study is designed to answer.
RP2D
RP2D as determined by incidence rate of DLTs
Measured: 42 days of study treatment
Safety and tolerability of RYZ101 in combination with SoC
Safety and tolerability of RYZ101 in combination with SoC as measured by incidence and severity of AEs including SAEs, laboratory changes and other safety findings
Measured: Up to 50 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2022
- Study start10 Oct 2022
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SCLC,Extensive StageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- RayzeBio, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Petrus De Jong, MD, Study director, RayzeBio, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05595460
- Sponsor's protocol ID
- RYZ101-101
- Status last verified
- Apr 2026
- First submitted
- 16 Sep 2022
- Last updated
- 13 Apr 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT05595460
- Acronym / sponsor ID
- RYZ101-101
- Conditions
- SCLC,Extensive Stage
- Keywords
- actinium, alpha-emitter, SSTR+ ES-SCLC, SCLC, ES-SCLC, RYZ101, 225Ac, 225Ac-DOTATATE
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 21 participants (actual)
- Lead sponsor
- RayzeBio, Inc.Industry (pharma, biotech, devices)
- Study start
- 10 Oct 2022 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 27 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RYZ101 + SoC | Experimental | Drug: RYZ101 Dose Level 1, Drug: RYZ101 Dose Level 2, Drug: RYZ101 Dose Level 3, Drug: RYZ101 Dose Level -1, Drug: Atezolizumab, Drug: Carboplatin, Drug: Etoposide |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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:
- 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
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RYZ101 Dose Level 1Dose Level 1 | Drug | RYZ101 + SoC |
| RYZ101 Dose Level 2Dose Level 2 | Drug | RYZ101 + SoC |
| RYZ101 Dose Level 3Dose Level 3 | Drug | RYZ101 + SoC |
| RYZ101 Dose Level -1Dose Level -1 | Drug | RYZ101 + SoC |
| AtezolizumabAtezolizumab | Drug | RYZ101 + SoC |
| CarboplatinCarboplatin | Drug | RYZ101 + SoC |
| EtoposideEtoposide | Drug | RYZ101 + SoC |
Primary outcome
RP2D
Time frame: 42 days of study treatment
RP2D as determined by incidence rate of DLTs
Safety and tolerability of RYZ101 in combination with SoC
Time frame: Up to 50 months
Safety and tolerability of RYZ101 in combination with SoC as measured by incidence and severity of AEs including SAEs, laboratory changes and other safety findings
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Petrus De Jong, MD study director
RayzeBio, Inc.
13 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing RYZ101 Dose Level 1, RYZ101 Dose Level 2 and RYZ101 Dose Level 3 in people with SCLC,Extensive Stage, run by RayzeBio, Inc. at 13 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
RP2D (time frame: 42 days of study treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026; AzTrials last refreshed its copy on 7 Nov 2026.