Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Rare Diseases

Lung Neoplasms

Small Cell Lung Carcinoma

Carcinoma

Carcinoma, Bronchogenic

Bronchial Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Small Cell Lung Cancer

Antineoplastic Agents

All Drugs and Chemicals

Etoposide

Carboplatin

Somatostatin

Atezolizumab

Etoposide phosphate

Radiopharmaceuticals

Enzyme Inhibitors

Immune Checkpoint Inhibitors

Antineoplastic Agents, Immunological

RYZ101 (Actinium 225 radiolabeled somatostatin analog (SSA)) 6.5 MBq/175 μCi in combination with standard of care (SoC) carboplatin + etoposide + atezolizumab

6.5 MBq/175 μCi administered by IV for up to 6 infusions once every 4 or 6 weeks

RYZ101 Dose Level 1

8.3 MBq/225 μCi administered by IV for up to 6 infusions once every 4 or 6 weeks

RYZ101 Dose Level 2

10.2 MBq/275 μCi administered by IV for up to 6 infusions once every 4 or 6 weeks

RYZ101 Dose Level 3

4.6 MBq/125 μCi administered by IV for up to 6 infusions once every 4 or 6 weeks

RYZ101 Dose Level -1

1200 mg administered IV for 4 x 21-day cycles, followed by 1680 mg every 28-days (maintenance)

AUC 5-6 administered IV for 4 x 21-day cycles

80-100 mg/m2 administered IV on 3 consecutive days for 4 x 21-day cycles

RayzeBio Clinical Trials

Jonathan Goldman

Megan Gee

Claire Mulvey, MD

Ephraim Parent, MD

Caitlin Mynard

Justin Rineer, MD

Mark Crystal

Manish Thakur, MD

Heather Austin

Krisha Howell, MD

Aaron Mansfield, MD

Marlene Bridwell

Robert Langdon, MD

John Waldron

John Waldron, MD

Sonam Puri, MD

Iris G. Garcia-Acevedo, BSN-RN

Noridza Rivera-Rodriguez, MD

Denise Ferreira, MD

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.

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

Phase 1b Single Arm, Open-label Trial of RYZ101 in Combination With Carboplatin + Etoposide + Atezolizumab in Subjects With Somatostatin Receptor Expressing (SSTR+) Extensive Stage Small Cell Lung Cancer (ES-SCLC)

RP2D as determined by incidence rate of DLTs

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

Durable ORR defined as the proportion of subjects with measurable disease at baseline who achieve confirmed CR or PR according to RECIST v1.1 lasting at least 4 months

ORR as assessed by the Investigator according to RECIST v1.1

Only for subjects with a RECIST v.1.1 response, assessed by the Investigator according to RECIST v1.1

OS as defined from the time of first dose of RYZ101 or first dose of SoC therapy to the date of death due to any cause

BOR as assessed by the Investigator according to RECIST v1.1

Disease control rate (PR + CR + SD) as assessed by the Investigator according to RECIST v1.1

PFS as defined from date of first dose of RYZ101 or first dose of SoC therapy to the date of progression as assessed by the Investigator according to RECIST v1.1

Spots Global Cancer Trial Database for ryz101 dose level 3