Phase 1a is designed to determine the recommended Phase 2 dose of ST-067 monotherapy using a modified toxicity probability interval (mTPI) design. ST-067 is administered as subcutaneous injection once weekly. Pre and on treatment biopsies will be mandated for all patients. There will be evaluation of PK and PD effects.~Phase 2 will evaluate the preliminary efficacy of ST-067 administered at the RP2D to patients with the following tumor types. A Simon 2 stage design is used to calculate the sample size and early stopping rules will be employed in the event of lack of efficacy in any of the cohorts. RECIST 1.1 will be used to assess tumor response every 8-12 weeks.~Melanoma (n=28)~Renal cell carcinoma (n=25)~Triple-negative best cancer (n=25)~Non-small cell lung cancer (n=25)~squamous cell carcinoma of the head and neck (n=28)~MSI-Hi tumors (n=25)~Safety will be assessed for each patient throughout the study.
This is a multicenter Phase 1a open-label, dose escalation study, and a Phase 2 study of ST-067. Phase 1a is a first-in-human (FIH) dose escalation study in patients aged 18 years or older diagnosed with solid tumors who have exhausted available standard. Phase 2 will enroll patients aged 18 years or older diagnosed with the following solid tumors: melanoma, renal cell carcinoma, triple negative breast cancer, non-small cell lung cancer, squamous cell carcinoma of the head and neck, and microsatellite instability-high tumors.