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

NCT05595460 | Active Not Recruiting Phase 1 FDA Drug

• 1 other identifier: RYZ101-101
• Study Type: interventional
• Target: 21
• Locations: 2 countries
• Sites: 13

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.

Conditions

SCLC,Extensive Stage

Keywords

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

Outcome Measures

Primary Outcomes (2)

• RP2D

  RP2D as determined by incidence rate of DLTs

  42 days of study treatment

• 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

  Up to 50 months

Study Arms (1)

RYZ101 + SoC

EXPERIMENTAL

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

Atezolizumab DRUG

Atezolizumab

RYZ101 + SoC

Carboplatin DRUG

Carboplatin

RYZ101 + SoC

Etoposide DRUG

Etoposide

RYZ101 + SoC

RYZ101 Dose Level -1 DRUG

Dose Level -1

RYZ101 + SoC

RYZ101 Dose Level 2 DRUG

Dose Level 2

RYZ101 + SoC

RYZ101 Dose Level 3 DRUG

Dose Level 3

RYZ101 + SoC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age of at least 18 years at the time of signing the informed consent.
• Cytologically or histologically confirmed ES-SCLC (American Joint Committee on Cancer \[AJCC\] 8th edition) and is untreated or received ≤1 cycle of platinum-etoposide and PD-L1 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 RECIST v1.1) and ≥50% of RECIST v1.1 measurable metastatic lesions must be SSTR-imaging positive.
• Adequate hematologic, renal and hepatic function

You may not qualify if:

• Prior exposure to immune-mediated therapy,
• Known active or suspected autoimmune disease or any condition requiring systemic treatment with immunosuppressive 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) metastases who have not recovered from acute side effects of radiotherapy.

Sponsors & Collaborators

• RayzeBio, Inc.: lead

Study Sites (13)

Research Facility

Los Angeles, California, 90024, United States

Location

Research Facility

San Francisco, California, 94158, United States

Location

Research Facility

Jacksonville, Florida, 32224, United States

Location

Research Facility

Miami, Florida, 33136, United States

Location

Research Facility

Orlando, Florida, 32806, United States

Location

Research Facility

Iowa City, Iowa, 52242, United States

Location

Reserach Facility

Lexington, Kentucky, 40536, United States

Location

Research Facility

Grand Rapids, Michigan, 49503, United States

Location

Research Facility

Rochester, Minnesota, 55905, United States

Location

Research Facility

St Louis, Missouri, 63130, United States

Location

Research Facility

Omaha, Nebraska, 68130, United States

Location

Research Facility

Salt Lake City, Utah, 84112, United States

Location

Research Facility

San Juan, Puerto Rico, 00935, Puerto Rico

Location

MeSH Terms

Interventions

atezolizumab; Carboplatin; Etoposide

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates

Study Officials

• Petrus De Jong, MD

  RayzeBio, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2022
• First Posted: October 27, 2022
• Study Start: October 10, 2022
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: April 13, 2026

Record last verified: 2026-04

Locations

US (12); PR (1)