Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

NCT05595460 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of SCLC,Extensive Stage, sponsored by RayzeBio.

Recruiting
Registry status
Phase 1
Development phase
49
Enrollment target
15
Study locations

NCT05595460: Recruiting Phase 1 study of SCLC,Extensive Stage, sponsored by RayzeBio.

NCT05595460 is a Phase 1 study of SCLC,Extensive Stage that is actively recruiting participants, run by RayzeBio. The registered enrollment target is 49 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (18% lower). The trial reports 15 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT05595460, a Phase 1 study of SCLC,Extensive Stage, is actively recruiting participants, sponsored by RayzeBio.

RECRUITING
Registry status
Phase 1
Development phase
49 participants
Enrollment target
15
Study locations

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.

Primary Outcome

RP2D as determined by incidence rate of DLTs

Conditions Studied

Interventions

  • DRUG Atezolizumab
  • DRUG RYZ101 Dose Level 1
  • DRUG RYZ101 Dose Level 2
  • DRUG RYZ101 Dose Level 3
  • DRUG RYZ101 Dose Level -1

Study Locations (15)

Florida

  • Research Facility - Jacksonville
  • Research Facility - Miami
  • Research Facility - Orlando

California

  • Research Facility - Los Angeles
  • Research Facility - San Francisco

Michigan

  • Research Facility - Grand Rapids
  • Research Facility - Troy

Iowa

  • Research Facility - Iowa City

Kentucky

  • Reserach Facility - Lexington

Minnesota

  • Research Facility - Rochester

Missouri

  • Research Facility - St Louis

Nebraska

  • Research Facility - Omaha

Trial Details

FieldValue
Enrollment Target 49 participants
Start Date 2022-10-10
Est. Completion 2029-03
Phase Phase 1
RayzeBio

5 total trials

What NCT05595460 shows while recruiting

NCT05595460 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 49 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (18% lower).

The record links to 1 condition, with SCLC,Extensive Stage appearing as the primary indexed condition, and to 5 interventions - of which Atezolizumab is the first listed.

NCT05595460 lists 15 locations in 11 states (Florida, California, Michigan).

Frequently Asked Questions

What is clinical trial NCT05595460 about?

NCT05595460 is a clinical study titled "Study of RYZ101 in Combination With SoC in Subjects With SSTR+ 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.

What is the current status of trial NCT05595460?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 49 participants. The study started on 2022-10-10. Estimated completion is 2029-03.

What conditions does trial NCT05595460 study?

This clinical trial studies the following conditions: SCLC,Extensive Stage.

What interventions are being tested in trial NCT05595460?

The interventions under investigation include: Atezolizumab (DRUG), RYZ101 Dose Level 1 (DRUG), RYZ101 Dose Level 2 (DRUG), RYZ101 Dose Level 3 (DRUG), RYZ101 Dose Level -1 (DRUG).

Who is sponsoring clinical trial NCT05595460?

This trial is sponsored by RayzeBio, which has 5 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05595460 being conducted?

This trial has 15 study locations across California, Florida, Iowa, Kentucky, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

How this trial's enrollment target compares

Where NCT05595460's enrollment target sits among peer trials

49 1017th of 2000 higher than 976 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

Nationwide trials with similar profiles

Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.

Similar enrollment target

  • NCT02704858 · 49 participants · Phase 1

    Safety and Efficacy Study in Recurrent or Progressive Grade III or IV IDH1 Mutated Glioma

  • NCT03516708 · 49 participants · Phase 1

    Epacadostat (INCB024360) Added to Preoperative Chemoradiation in Patients With Locally Advanced Rectal Cancer

  • NCT03692429 · 49 participants · Phase 1

    alloSHRINK - Standard cHemotherapy Regimen and Immunotherapy With Allogeneic NKG2D-based CYAD-101 Chimeric Antigen Receptor T-cells

  • NCT04329494 · 49 participants · Phase 1

    PIPAC for the Treatment of Peritoneal Carcinomatosis in Patients With Ovarian, Uterine, Appendiceal, Colorectal, or Gastric Cancer

Similar registry start date

  • NCT05962346 · started 2026-12 · NA

    Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia

  • NCT07125183 · started 2026-12 · Phase 2

    Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma

  • NCT07292298 · started 2026-11 · Phase 2

    Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates

  • NCT04263285 · started 2026-10 · NA

    Treatment of Depression Post-SCI

Source: ClinicalTrials.gov NCT05595460, the US trial registry maintained by the National Library of Medicine. NCT05595460 (small enrollment · multi site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.