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

Phase 1

Recruiting

• Conditions: SCLC,Extensive Stage
• Interventions: 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

• Registration Number: NCT05595460
• Lead Sponsor: RayzeBio, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-09-16
• Study Start: 2022-10-10
• Study First Submitted QC: 2022-10-24
• Study First Posted: 2022-10-27
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-21
• Last Update Posted: 2025-05-25
• Primary Completion: 2027-06
• Study Completion: 2029-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 49

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
RYZ101 + SoC	RYZ101 Dose Level 1	-
RYZ101 + SoC	RYZ101 Dose Level 2	-
RYZ101 + SoC	RYZ101 Dose Level 3	-
RYZ101 + SoC	RYZ101 Dose Level -1	-
RYZ101 + SoC	Atezolizumab	-
RYZ101 + SoC	Carboplatin	-
RYZ101 + SoC	Etoposide	-

Primary Outcome Measures

Name	Time	Method
RP2D	42 days of study treatment	RP2D as determined by incidence rate of DLTs
Safety and tolerability of RYZ101 in combination with SoC	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

Trial Locations

Locations (2)

Research Facility; 🇵🇷 San Juan, Puerto Rico

Reserach Facility; 🇺🇸 Lexington, Kentucky, United States