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Monoclonal Antibodies

RYZ101 + Standard Treatments for Small Cell Lung Cancer

Phase 1
Recruiting
Research Sponsored by RayzeBio, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Candidate for therapy with SoC including Carboplatin for a maximum of 4 cycles, Etoposide for a maximum of 4 cycles, Atezolizumab
Adequate hepatic function with Total bilirubin ≤1.5 × ULN, Aspartate aminotransferase (AST)/serum glutamic-oxaloacetic transaminase (SGOT) and alanine aminotransferase (ALT)/serum glutamic-pyruvic transaminase (SGPT) ≤2.5 × ULN
Must not have
Known active or suspected autoimmune disease, including paraneoplastic syndromes of autoimmune nature
Contraindication to receive carboplatin or etoposide
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 50 months
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new drug, RYZ101, combined with standard cancer treatments in patients with a specific type of untreated lung cancer. The new drug aims to target certain receptors on cancer cells, while the other drugs work to kill the cancer cells and help the immune system fight them.

Who is the study for?
This trial is for adults with untreated ES-SCLC that expresses somatostatin receptors. Participants must have adequate organ function, no severe allergies to certain drugs or cell products, and not be pregnant or breastfeeding. They should not have had major surgery recently, active infections like TB or hepatitis, significant heart disease, other cancers in the last 3 years (with some exceptions), or a history of severe allergic reactions.
What is being tested?
The study tests RYZ101 at various doses combined with standard chemotherapy (carboplatin + etoposide) and immunotherapy (atezolizumab) in patients with SSTR+ ES-SCLC. It aims to assess safety, how well it works against cancer cells, and how the body processes the drug.
What are the potential side effects?
Potential side effects include those common to chemotherapy such as nausea, fatigue, hair loss; immunotherapy-related issues like inflammation of organs; infusion reactions from antibodies; blood disorders; increased risk of infection due to immune system suppression.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am eligible for standard cancer treatment including Carboplatin, Etoposide, and Atezolizumab.
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My liver tests are within normal limits.
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My small cell lung cancer is confirmed and I've had at most one treatment with specific drugs.
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I am fully active or restricted in physically strenuous activity but can do light work.
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My scans show a positive result for a specific cancer marker and at least half of my cancer spots can be measured.
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My blood counts meet the required levels for treatment.
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My kidneys work well, with a creatinine clearance rate of 60 mL/min or higher.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have an autoimmune disease or symptoms suggesting one.
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I cannot take carboplatin or etoposide due to health reasons.
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I have brain metastases from cancer and am still experiencing side effects from radiotherapy.
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I have had a previous transplant of stem cells or an organ.
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I do not have active infections like TB, hepatitis B or C, or HIV, nor am I on antiviral therapy for HBV.
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I do not have serious heart disease or a long QT interval.
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My high blood pressure doesn't improve with medication.
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I have a history of lung scarring or inflammation not caused by infections.
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I have undergone peptide receptor radionuclide therapy.
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I am allergic to certain medical imaging agents or their components.
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I have had or will have chest radiation before systemic therapy or had significant radiation to my bone marrow.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 50 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 50 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
RP2D
Safety and tolerability of RYZ101 in combination with SoC
Secondary study objectives
BOR
DOR
Disease Control Rate
+10 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: RYZ101 + SoCExperimental Treatment7 Interventions
RYZ101 (Actinium 225 radiolabeled somatostatin analog (SSA)) 6.5 MBq/175 μCi in combination with standard of care (SoC) carboplatin + etoposide + atezolizumab
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Atezolizumab
2017
Completed Phase 3
~5850
Etoposide
2010
Completed Phase 3
~2960
Carboplatin
2014
Completed Phase 3
~6120

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Small Cell Lung Cancer (SCLC) include chemotherapy regimens such as etoposide combined with either cisplatin or carboplatin. These agents work by damaging the DNA of cancer cells, thereby inhibiting their ability to replicate and leading to cell death. Additionally, immune checkpoint inhibitors like atezolizumab, which target PD-L1, help the immune system recognize and attack cancer cells. Emerging treatments, such as the somatostatin receptor targeting agent RYZ101, aim to deliver cytotoxic agents directly to cancer cells expressing somatostatin receptors, potentially increasing treatment efficacy while minimizing damage to healthy cells. These mechanisms are crucial for SCLC patients as they offer targeted approaches that can improve outcomes and reduce side effects compared to traditional therapies.
Current and evolving treatment options for limited stage small cell lung cancer.

Find a Location

Who is running the clinical trial?

RayzeBio, Inc.Lead Sponsor
4 Previous Clinical Trials
520 Total Patients Enrolled
Denise Ferreira, MDStudy DirectorRayzeBio, Inc.

Media Library

Atezolizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05595460 — Phase 1
Small Cell Lung Cancer Research Study Groups: RYZ101 + SoC
Small Cell Lung Cancer Clinical Trial 2023: Atezolizumab Highlights & Side Effects. Trial Name: NCT05595460 — Phase 1
Atezolizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05595460 — Phase 1
~4 spots leftby Mar 2025