A Phase 1-2 Study of ST101 in Patients With Advanced Solid Tumors (NCT04478279) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
A Phase 1-2 Study of ST101 in Patients With Advanced Solid Tumors
United States125 participantsStarted 2020-07-01
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Able and willing to sign informed consent form (ICF) and comply with the protocol and the restrictions and assessments therein.
✓. Male or female ≥18 years of age.
✓. Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
✓. Must have a locally advanced or metastatic inoperable tumor as follows:
✓. For the dose escalation/regimen exploration phase: melanoma, carcinoma, or sarcoma
✓. For the expansion phase: HR positive LA/MBC, melanoma, GBM, CRPC
✓. Agrees to provide a newly obtained biopsy of an accessible lesion (if they can be biopsied based on the investigator's assessment) prior to the start of study treatment, and to repeat biopsy once during study treatment. Tissue obtained for the biopsy must not be previously irradiated (unless progressing following irradiation), but a new or progressing lesion in the radiation field is acceptable. Archived biopsies are acceptable for GBM patients.
✓. In the investigator's opinion, the patient may not derive clinical benefit from, or is ineligible for, a particular form of standard therapy on medical grounds, or the patient failed or did not tolerate one or more of other anti-cancer therapies:
Exclusion criteria
✕. Use of small molecule or tyrosine kinase inhibitor within 2 weeks or 5 half-lives (whichever is shorter) prior to the first dose of study drug; chemotherapy, investigational drug or biological cancer therapy within 3 weeks prior to the first dose of study therapy; nitrosourea or radioisotope within 6 weeks prior to first dose.
✕. Known hypersensitivity to ST101 or any of its excipients.
✕. Baseline corrected interval between q and t wave on electrocardiogram (ECG) (QTc) \> 480 msec using Fredericia's formula.
✕. Symptomatic ascites or pleural effusion. A patient who is clinically stable following treatment for these conditions (including therapeutic thoraco- or paracentesis) is eligible.
✕. Known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Patients with previously treated brain metastases may participate provided they are clinically stable for at least 4 weeks prior to study entry, have no evidence of new or enlarging brain metastases, and are off steroids for at least 14 days prior to first dose of study drug. This criterion does not apply to patients on the GBM cohort.
✕. Presence of any other active malignancy requiring systemic therapy other than the disease under study.
✕. Active infection with human immunodeficiency virus (HIV) and CD4+ T-cell count \<350/μL. Patients not on established ART for at least four weeks and having a detectable HIV viral load. Testing is not required for eligibility.
✕. Active infection with hepatitis B or hepatitis C, defined by a detectable viral load. Testing is not required for eligibility.