Merkel Cell Carcinoma, Small Cell Lung Cancer Extensive Stage
Conditions
Keywords
actinium, 225Ac, actinium-225, SSO110, SSO120, gallium, 68Ga, gallium-68, radiopharmaceutical, MCC, Merkel Cell carinoma, ES-SCLC, Extensive Stage Small Cell Lung Cancer, radioligand, somatostatin receptor 2, JR11, sstr2-antagonist
Brief summary
This study aims to determine safety, tolerability, recommended phase 2 dose (RP2D), and preliminary antitumor activity of 225Ac-SSO110 with standard of care (SoC) therapy in patients with somatostatin receptor 2 expressing (SSTR2+) extensive-stage small cell lung cancer (ES-SCLC) and recurrent locally advanced or metastatic Merkel cell carcinoma (MCC).
Interventions
DRUG225Ac-SSO110 + SoC
Dose Level -2-7
DRUGAtezolizumab
Extensive Stage Small Cell Lung Cancer Checkpoint Inhibitor (SoC)
DRUGDurvalumab
Extensive Stage Small Cell Lung Cancer Checkpoint Inhibitor (SoC)
DRUGAvelumab
Merkel Cell Carcinoma Checkpoint Inhibitor (SoC)
DRUGPembrolizumab
Merkel Cell Carcinoma Checkpoint Inhibitor (SoC)
DRUGRetifanlimab
Merkel Cell Carcinoma Checkpoint Inhibitor (SoC)
Sponsors
Ariceum Therapeutics GmbH
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Signed Informed Consent Form and willing to comply with all study procedures. * Participants with ES-SCLC (defined as Stage IV per NCCN guidelines Version 1.2024) or recurrent locally advanced or metastatic MCC (per NCCN guidelines Version 1.2024) documented by histology or cytology. * Participants eligible to receive immune checkpoint inhibitor (CPI) monotherapy at the start of treatment with 225Ac-SSO110 or patients already on CPI monotherapy for 7 weeks. * ECOG performance status of 0 or 1. Life expectancy of at least 6 months. * Positive 68Ga-SSO120 scan (Investigator-assessed) during screening. Key
Exclusion criteria
* Participants with unstable spinal cord compression. * Any previous systemic radioligand therapy or extensive radiotherapy. * Participants receiving or planned to receive consolidative chest radiation. * History of primary immunodeficiency, transplantation or CAR-T cell therapy. * Major surgical procedure except diagnostic biopsy within 28 days prior to enrolment or scheduled to have major surgery during the study. * Inadequate organ or marrow function.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Part 1: Safety, tolerability, RP2D of 225Ac-SSO110 in combination with SoC | 42 days | Identification of the DLT rate per dose level |
| Part 2: Safety, tolerability, and preliminary anti-tumor activity of 225Ac-SSO110 in combination with SoC at RP2D | 42 days | Rate of serious adverse events, adverse events, laboratory parameters, and other safety findings, Preliminary anti-tumor activity of 225Ac-SSO110 as assessed by progression free survival (PFS), disease control rate (DCR), best observed response (BOR), overall response rate (ORR), duration of response (DoR) |
| Part 1 & 2: Safety and tolerability of 68Ga-SSO120 | 7 days | Rate of serious adverse events, adverse events, laboratory parameters, and other safety findings |
Countries
Australia, United States
Outcome results
None listed