Sanford Health | Clinical Research Department
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This is a first-in-human, phase 1, open-label, dose-escalation study of STI-6643 administered by intravenous infusion in subjects with a relapsed/refractory advanced solid tumor.
Full description
This is a first-in-human, phase 1, open-label, dose-escalation study of STI-6643 administered by intravenous infusion in subjects with a relapsed/refractory advanced solid tumor.
The study will determine an MTD and RP2D using a conventional 3+3 study design with priming dose identification (PDI) stage and therapeutic dose (TD) escalation (TDE) stage. Dose limiting toxicity evaluated over the initial 28 days of STI-6643 administration.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Signed informed consent
Age ≥ 18 years
ECOG Performance Status ≤ 2
Histologically- or cytologically-confirmed solid tumor
Patient has relapsed, is refractory to, or intolerant of standard of care therapy
No available approved therapy that may provide clinical benefit (per Investigator)
Measurable or evaluable disease by RECISTv1.14
Life expectancy of > 12 weeks (per Investigator)
Adequate laboratory parameters including:
If residual treatment related toxicity from prior therapy:
Willingness to comply with the study schedule and all study requirements
[Females] Must be postmenopausal, surgically sterile, or agree to use adequate contraception (per Investigator) throughout the study and for a least 30 days following the last dose
[Males] Must be surgically sterile or must agree to use adequate contraception (per Investigator) throughout the study and for at least 30 days following the last dose
[Males] Willingness to refrain from donating sperm throughout the study and for at least 30 days following the last dose
[Females] If of child-bearing potential, must have a negative serum pregnancy test
Exclusion criteria
Participating in any other interventional clinical study
Previous exposure to an anti-CD47 or SIRPα antibody
≤ 28 days (or 5 half-lives if shorter) between of systemic anti-tumor treatment (e.g., chemotherapy, endocrine therapy, immunotherapy, cellular therapy) and the 1st dose of STI-6643
≤ 28 days from prior irradiation (≤ 7 days from limited field irradiation for control of symptoms) and the 1st dose of STI-6643
≤ 28 days between major surgery (≤ 7 days from minor surgical procedures, no waiting period following central catheter placement)
≤ 7 days between administration of G-CSF, GM-CSF, erythropoietin, thrombopoietin or IL11 and the 1st dose of STI-6643
≤ 7 days between systemic immunosuppressive therapy in excess of 10 mg/day prednisone equivalent and the 1st dose of STI-6643 (topical or inhaled corticosteroids not restricted)
≤ 28 days between a live attenuated vaccine and the 1st dose of STI-6643
Known central nervous system (CNS) involvement with tumor (e.g., metastases, meningeal carcinomatosis)
Active second malignancy requiring ongoing systemic treatment
History of primary immunodeficiency disorders
History of active pulmonary tuberculosis
History of COVID-19 symptoms unless COVID-19 test negative ≤ 72 hours of the 1st dose of STI-6643
≤ 12 weeks from an allogeneic hematopoietic stem cell transplant and C1D1 or active graft-versus-host disease (GvHD)
Active infection (e.g., bacterial, viral, fungal) requiring systemic treatment ≤ 72 hours of the 1st dose of STI-6643
Known HIV-positive with CD4+ cell counts < 350 cells/uL or a history of an AIDS defining opportunistic infection
Known T-cell leukemia virus type 1 (HTLV1) infection, hepatitis B virus (HBV) or hepatitis C virus (HCV) viremia
Significant risk for HBV reactivation (defined as HbsAg positive, HbcAb positive or HBV DNA positive)
Detectable HCV RNA
Pregnant or breast feeding
History of clinically significant cardiovascular abnormalities including:
Any condition, including the presence of laboratory abnormalities, that places the subject at an unacceptable risk if the subject was to participate in the study.
Primary purpose
Allocation
Interventional model
Masking
100 participants in 1 patient group
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Central trial contact
Mike Royal, MD
Data sourced from clinicaltrials.gov
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