RYZ101 + SoC for Small Cell Lung Cancer, Extensive Stage

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Small Cell Lung Cancer, Extensive StageCarboplatin - Drug
Eligibility
18+
All Sexes
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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.

Eligible Conditions
  • Small Cell Lung Cancer, Extensive Stage

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 13 Secondary · Reporting Duration: Up to 50 months

Day 42
RP2D
Up to 50 months
BOR
DOR
Disease Control Rate
Durable ORR
ORR
OS
PFS
Safety and tolerability of RYZ101 in combination with SoC
Up to 8 days
PK parameter: Area under the concentration-time curve (AUC) of RYZ101 in combination with SoC
PK parameter: Clearance of RYZ101 in combination with SoC
PK parameter: Maximum observed concentration (Cmax) of RYZ101 in combination with SoC
PK parameter: Terminal half life (T1/2) of RYZ101 in combination with SoC
PK parameter: Time to maximum observed concentration (Tmax) of RYZ101 in combination with SoC
PK parameter: Volume of distribution (V) of RYZ101 in combination with SoC

Trial Safety

Safety Progress

1 of 3

Trial Design

1 Treatment Group

RYZ101 + SoC
1 of 1

Experimental Treatment

31 Total Participants · 1 Treatment Group

Primary Treatment: RYZ101 + SoC · No Placebo Group · Phase 1

RYZ101 + SoCExperimental Group · 7 Interventions: Carboplatin, RYZ101 Dose Level 1, RYZ101 Dose Level -1, RYZ101 Dose Level 2, Atezolizumab, RYZ101 Dose Level 3, Etoposide · Intervention Types: Drug, Drug, Drug, Drug, Drug, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Carboplatin
2014
Completed Phase 3
~7230
Atezolizumab
2016
Completed Phase 4
~7560
Etoposide
2010
Completed Phase 3
~2380

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 50 months

Who is running the clinical trial?

RayzeBio, Inc.Lead Sponsor
1 Previous Clinical Trials
218 Total Patients Enrolled
Denise Ferreira, MDStudy DirectorRayzeBio, Inc.

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a good performance status (PS) of 0 or 1.
Subjects should have ionized calcium ≤1.