Phase 1a and Phase 2 Study for Safety, Preliminary Efficacy, PK and PD of ST-067
Cancer, Solid Tumor, Melanoma
About this trial
This is an interventional treatment trial for Cancer
Eligibility Criteria
Inclusion Criteria:
- Male and female patients aged ≥18 years
- Must provide written informed consent and any authorizations required by local law
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Have histologically or cytologically confirmed diagnosis of advanced/metastatic solid tumor
For Phase 1a, the following solid tumors are allowed: Melanoma, Merkel cell, RCC, urothelial, NSCLC,TNBC, SCCHN, microsatellite instability high, high tumor mutation burden (Hi TMB) or mismatch repair deficient, gastric, cervical, endometrial, cutaneous squamous, small cell lung, esophageal, hepatocellular carcinoma and platinum resistant ovarian cancer.
- For patients who have developed disease progression through standard therapy, or
- For patients whom standard of care therapy that prolongs survival is not available or suitable (according to the investigator and after consultation with the Medical Monitor)
For Phase 2, the following solid tumors are allowed:
Melanoma, RCC, TNBC, NSCLC, SCCHN, and MSI-Hi tumors
- Has at least 1 measurable lesion per RECIST 1.1 criteria which has not been biopsied or received prior irradiation
- Has an accessible tumor for biopsy pre- and on-treatment (mandatory).
Exclusion Criteria:
- History of another malignancy
- Known symptomatic brain metastases requiring >10 mg/day of prednisolone
- Significant cardiovascular disease
- Significant ECG abnormalities i
- Evidence of an ongoing systemic bacterial, fungal, or viral infection
- Has received a live vaccine within 30 days
- Major surgery within 4 weeks
- Prior solid organ or bone marrow progenitor cell transplantation
- Prior high dose chemotherapy requiring stem cell rescue
- History of active autoimmune disorders
- Ongoing immunosuppressive therapy, including systemic or enteric corticosteroids.
Sites / Locations
- HonorHealth Research InstituteRecruiting
- Sarah Cannon Research Institute at HealthONERecruiting
- Yale Cancer CenterRecruiting
- Moffitt Cancer CenterRecruiting
- Massachusetts General HospitalRecruiting
- Roswell Park Cancer InstituteRecruiting
- Providence Cancer Institute Franz ClinicRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Experimental
Phase 1a, Dose Escalation
Phase 2, Expansion
Phase 1a, Dose Escalation, ST-067 SC + Obinutuzumab Pre-treatment
Phase 1 combination therapy
In the Phase 1a monotherapy study, the starting dose of ST-067 will be 30 μg/kg, with a total of 7 dose level cohorts planned. The starting dose for the IV infusion monotherapy dosing will be 60 µg/kg. Patients will be treated every week with ST-067 in all cohorts. The DLT period is 28 days after the initial dose of ST-067. According to the mTPI schema initially there will be 3 patients per cohort until the first DLT is observed at which point cohorts will be expanded according to the predetermined mTPI design. Up to 12 patients will be treated at the RP2D.
Phase 2 will enroll patients aged 18 years or older diagnosed with the following solid tumors: melanoma, renal cell carcinoma (RCC), triple negative breast cancer (TNBC), non-small cell lung cancer (NSCLC), squamous cell carcinoma of the head and neck (SCCHN), and microsatellite instability-high (MSI-Hi) tumors at the RP2D.
Patients will be treated every week with ST-067 in all cohorts. The DLT period is 28 days after the initial dose of ST-067. According to the mTPI schema initially there will be 3 patients per cohort until the first DLT is observed at which point cohorts will be expanded according to the predetermined mTPI design. The starting dose for ST-067 with obinutuzumab pre-treatment will be 120µg/kg. Obinutuzumab will be administered at 1000 mg daily via IV infusion on 2 consecutive days, with the first dose given at least 7 days prior to first dose of SC ST-067.
Phase 1 dose escalation in combination with pembrolizumab will start at a dose of 30 µg/kg of ST-067 and 200 mg every 3 weeks of pembrolizumab. Patients will be treated every week with ST-067 and every three weeks with pembrolizumab. The MTD will be determined based on the mTPI design.