ClinicalTrials.gg
Active, not recruitingNCT05595460Updated Apr 13, 2026

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

A Phase 1 interventional study of RYZ101 Dose Level 1 and RYZ101 Dose Level 2 in SCLC,Extensive Stage, sponsored by RayzeBio, Inc.. Active, not recruiting at 13 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-13.

Sponsored by RayzeBio, Inc. (part of Bristol-Myers Squibb) · Phase 1, Interventional, and Treatment

Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →

Phase
Phase 1
Study type
Interventional
Enrollment
21
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • SCLC,Extensive Stage

Keywords

  • actinium
  • alpha-emitter
  • SSTR+ ES-SCLC
  • SCLC
  • ES-SCLC
  • RYZ101
  • 225Ac
  • 225Ac-DOTATATE
  • targeted radiotherapy
  • atezolizumab
  • carboplatin
  • etoposide
  • radiopharmaceutical
03

In context

Lead sponsor

RayzeBio, Inc. is the lead sponsor of 8 studies on the registry; 6 are open to participants now.

First submitted before RayzeBio, Inc. became part of Bristol-Myers Squibb.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age of at least 18 years at the time of signing the .
  • or histologically confirmed ES-SCLC (American Joint Committee on Cancer [AJCC] 8th edition) and is untreated or received ≤1 cycle of platinum-etoposide and 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 v1.1) and ≥50% of RECIST v1.1 measurable lesions must be SSTR-imaging positive.
  • Adequate hematologic, renal and hepatic function

Exclusion criteria

EXCLUSION CRITERIA

  • Prior exposure to immune-mediated therapy,
  • Known active or suspected disease or any condition requiring systemic treatment with 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) who have not recovered from acute side effects of radiotherapy.
Terms in these criteria, in plain language(7)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

PD-1, PD-L1 and checkpoint inhibitors

PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.

PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.

RECIST

The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.

“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
21 participants (actual)

Study arms

  • Experimental
    RYZ101 + SoC

    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

Interventions

06

What researchers measure

Primary outcomes

  1. RP2D

    RP2D as determined by incidence rate of DLTs

    Time frame: 42 days of study treatment

  2. 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

    Time frame: Up to 50 months

07

Study locations

13 sites
  • Research Facility
    Los Angeles, California 90024, United States
  • Research Facility
    San Francisco, California 94158, United States
  • Research Facility
    Jacksonville, Florida 32224, United States
  • Research Facility
    Miami, Florida 33136, United States
  • Research Facility
    Orlando, Florida 32806, United States
  • Research Facility
    Iowa City, Iowa 52242, United States
  • Reserach Facility
    Lexington, Kentucky 40536, United States
  • Research Facility
    Grand Rapids, Michigan 49503, United States
  • Research Facility
    Rochester, Minnesota 55905, United States
  • Research Facility
    St Louis, Missouri 63130, United States
  • Research Facility
    Omaha, Nebraska 68130, United States
  • Research Facility
    Salt Lake City, Utah 84112, United States
  • Research Facility
    San Juan, Puerto Rico 00935, Puerto Rico
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Oct 2022 (actual). Primary completion is estimated for Jul 2027, 57 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 16, 2022
First posted
Oct 27, 2022
StartActual
Oct 10, 2022
Primary completionEst.
Jul 2027
CompletionEst.
Jul 2027
Last update
Apr 13, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 13, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05595460
Lead sponsor
RayzeBio, Inc.
Responsible party
Sponsor
First posted
Oct 27, 2022
Start date
Oct 10, 2022
Primary completion
Jul 2027 (estimated)
Completion
Jul 2027 (estimated)
Last update
Apr 13, 2026

Study contacts

Petrus De Jong, MD
study director · RayzeBio, Inc.

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: Actinium AC-225 dotatate

Start the discussion