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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
2
Dose Level -2-7
Extensive Stage Small Cell Lung Cancer Checkpoint Inhibitor (SoC)
Extensive Stage Small Cell Lung Cancer Checkpoint Inhibitor (SoC)
Biogenix Molecular
Miami, Florida, United States
University of Louisville Health-Brown Cancer Center
Louisville, Kentucky, United States
United Theranostics
Glen Burnie, Maryland, United States
John Theurer Cancer Center at Hackensack UMC
Hackensack, New Jersey, United States
Part 1: Safety, tolerability, RP2D of 225Ac-SSO110 in combination with SoC
Identification of the DLT rate per dose level
Time frame: 42 days
Part 2: Safety, tolerability, and preliminary anti-tumor activity of 225Ac-SSO110 in combination with SoC at RP2D
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)
Time frame: 42 days
Part 1 & 2: Safety and tolerability of 68Ga-SSO120
Rate of serious adverse events, adverse events, laboratory parameters, and other safety findings
Time frame: 7 days
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Merkel Cell Carcinoma Checkpoint Inhibitor (SoC)
Merkel Cell Carcinoma Checkpoint Inhibitor (SoC)
Merkel Cell Carcinoma Checkpoint Inhibitor (SoC)
UPMC
Pittsburgh, Pennsylvania, United States
Virginia Cancer Specialists, PC
Fairfax, Virginia, United States
GenesisCare
Alexandria, Australia