This is an open-label, two-part, phase 1-2 dose-finding study designed to determine the
safety, tolerability, PK, PD, and proof-of-concept efficacy of ST101 administered IV in
patients with advanced solid tumors. The study consists of two phases: a phase 1 dose
escalation/regimen exploration phase and a phase 2 expansion phase.
Dose escalation / regimen exploration phase During the dose escalation/regimen exploration
phase, only patients diagnosed with locally advanced or metastatic melanoma, carcinoma or
sarcoma of any tumor type who are refractory or intolerant to all available therapies that
would impact survival will be enrolled.
ST101 will be administered intravenously (IV), initially once per week. The dose escalation
cohorts will be recruited using a standard 3+3 design. At each new dosing cohort, there will
be a 1-week observation period after dosing the first patient in order to assess safety prior
to dosing the remainder of the patients in that cohort. The dose cohorts will be 0.5, 1, 2,
4, 8 and 16 mg/kg with once weekly (QW) dosing in all cohorts except for the highest dose
level which will be dosed every other week (Q2W).
The expansion phase consists of 4 specific tumor-type cohorts, which each follow the same
Simon 2-stage design. Fifteen (15) patients will be enrolled in each cohort and treated with
the ST101 RP2D. If one or more responses is observed that cohort will be expanded to a total
of 30 patients to further assess efficacy.
Responses will be graded using response evaluation criteria in solid tumors (RECIST) 1.1
(Eisenhauer 2009) for hormonal receptor positive (HRpos) locally advanced/metastatic breast
cancer (LA/MBC) and melanoma, modified response assessment in neuro-oncology (RANO)
(Ellingson 2017) for GBM and prostate cancer clinical trials working group 3 (PCWG3) (Scher
2016) for castration-resistant prostate cancer (CRPC).During the expansion phase, only
patients diagnosed with the following tumor types will be allowed into this phase of the
HRpos LA/MBC that has progressed after prior 1-2 hormone-based therapies. Previous
treatment with cyclin-dependent kinase 4/6 (CDK4/6) inhibitor, mammalian target of
rapamycin (mTOR) inhibitor or chemotherapy is allowed as monotherapy or in combination.
Melanoma that has progressed after/or on treatment with an immune checkpoint inhibitor
(CPI) and have received 1-2 prior lines of therapy for their advanced/metastatic
disease. Patients that have BRAF mutated disease should also have received one line of
appropriate targeted therapy.
Primary (de novo) GBM that has recurred or progressed (per modified RANO criteria) after
1 standard treatment regimen. Standard therapy is defined as maximal surgical resection,
radiotherapy, and concomitant temozolomide with radiotherapy or adjuvant chemotherapy
with temozolomide. Patients that undergo tumor treating fields as an adjuvant to first
line therapy are allowed.
CRPC that has progressed after previous treatment with taxanes, abiraterone and
The tumor types in the expansion phase may change based on emerging data from the dose
escalation phase of this study. Additional mini cohorts of 10 patients may be added to the
expansion phase based on efficacy signals during the dose escalation phase.
Glioblastoma, Melanoma Stage IV, Melanoma Recurrent, Breast Cancer, Prostate Cancer, Glioblastoma Multiforme, GBM, Brain Cancer, Metastatic Breast Cancer, Metastatic Melanoma, Metastatic Prostate Cancer, Prostate Cancer Metastatic
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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