Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
completion around
Principal Investigator
by Claire Mulvey
Headshot of Claire Mulvey
Claire Mulvey

Description

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.

Official Title

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)

Keywords

SCLC,Extensive Stage, actinium, alpha-emitter, SSTR+ ES-SCLC, SCLC, ES-SCLC, RYZ101, 225Ac, 225Ac-DOTATATE, targeted radiotherapy, atezolizumab, carboplatin, etoposide, radiopharmaceutical, Small Cell Lung Carcinoma, RYZ101 Dose Level 1, RYZ101 Dose Level 2, RYZ101 Dose Level 3, RYZ101 Dose Level -1

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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 CAN'T join 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.

Locations

  • Research Facility accepting new patients
    San Francisco California 94158 United States
  • Research Facility accepting new patients
    Los Angeles California 90024 United States

Lead Scientist at UCSF

  • Claire Mulvey
    Assistant Professor, Medicine, School of Medicine. Authored (or co-authored) 47 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
RayzeBio, Inc.
ID
NCT05595460
Phase
Phase 1 Lung Cancer Research Study
Study Type
Interventional
Participants
Expecting 49 study participants
Last Updated