Clinical trial NCT05595460: Study of RYZ101 in Combination With SoC in Subjects With 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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: SCLC,Extensive Stage
Keywords: actinium
alpha-emitter
SSTR+ ES-SCLC
SCLC
ES-SCLC
RYZ101
225Ac
225Ac-DOTATATE
targeted radiotherapy
atezolizumab
carboplatin
etoposide
radiopharmaceutical
Lead sponsor: RayzeBio, Inc.
Sponsor class: INDUSTRY
First posted: 2022-10-27
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: INCLUSION CRITERIA

* 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

EXCLUSION CRITERIA

* 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.

Primary outcomes:
measure: RP2D
timeFrame: 42 days of study treatment
measure: Safety and tolerability of RYZ101 in combination with SoC
timeFrame: Up to 50 months
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Research Facility
state: California
city: San Francisco
country: United States
facility: Research Facility
state: California
city: Jacksonville
country: United States
facility: Research Facility
state: Florida
city: Miami
country: United States
facility: Research Facility
state: Florida
city: Orlando
country: United States
facility: Research Facility
state: Florida
city: Iowa City
country: United States
facility: Research Facility
state: Iowa
city: Lexington
country: United States
facility: Reserach Facility
state: Kentucky
city: Grand Rapids
country: United States
facility: Research Facility
state: Michigan
city: Troy
country: United States
facility: Research Facility
state: Michigan
city: Rochester
country: United States
facility: Research Facility
state: Minnesota
city: Saint Louis
country: United States
facility: Research Facility
state: Missouri
city: Omaha
country: United States
facility: Research Facility
state: Nebraska
city: Houston
country: United States
facility: Research Facility
state: Texas
city: Salt Lake City
country: United States
facility: Research Facility
state: Utah
city: San Juan
country: Puerto Rico
facility: Research Facility
Study officials:
affiliation: RayzeBio, Inc.
name: Petrus De Jong, MD
role: STUDY_DIRECTOR
References: