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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 50 months
Awards & highlights

Study Summary

This trial will test a new drug to see if it can help treat a type of lung cancer when combined with existing treatments.

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.Check my eligibility
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.See study design
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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I am a man who will use a condom and avoid fathering a child for 3 months after the last study drug dose.
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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.

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

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

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
Carboplatin
2014
Completed Phase 3
~6670
Atezolizumab
2016
Completed Phase 3
~6040
Etoposide
2010
Completed Phase 3
~2440

Find a Location

Who is running the clinical trial?

RayzeBio, Inc.Lead Sponsor
2 Previous Clinical Trials
318 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment in this clinical experiment still available?

"Indeed, the clinical trial is actively seeking participants. It was initially made public on October 10th 2022 and has been updated to include new information as of November 18th 2022."

Answered by AI

How hazardous are the effects of RYZ101 when administered in conjunction with standard-of-care?

"RYZ101 + SoC's safety was deemed a 1 on the scale of 1 to 3, as this is an early-stage Phase 1 trial with scant evidence supporting its efficacy and safety."

Answered by AI

How many participants are being monitored for this clinical experiment?

"Accurate. Clinicaltrials.gov's records suggest that this medical trial is currently recruiting volunteers; the trial was first released on October 10th 2022 and recently updated on November 18th 2022. The study requires 31 participants from one site."

Answered by AI
~0 spots leftby Apr 2024