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An open label, dose escalation and dose expansion study to evaluate the safety, tolerability, and anti-tumor activity of STP707 with IV administration in subjects with advanced/metastatic or surgically unresectable solid tumors who are refractory to standard therapy.
Full description
A phase 1, open label, dose escalation and dose expansion study to evaluate the safety, tolerability, and anti-tumor activity of STP707 with IV administration in subjects with advanced/metastatic or surgically unresectable solid tumors who are refractory to standard therapy.
The primary objective of this study is to determine the MTD or RP2D of STP707 and to establish the dose of STP707 recommended for future phase 2 studies administered intravenously.
A total of 30 subjects will be enrolled in dose escalation. Once MTD or RP2D has been established, up to 10 additional subjects will enrolled to confirm safety and explore anti-tumor activity.
Up to 5 dose levels will be explored (3,6,12,24,48 mg dose levels). Intermediate doses between scheduled dose levels maybe explored during escalation. A cycle is 28 days.
Dose escalation will follow a standard 3+3 design.
Enrollment
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Volunteers
Inclusion criteria
Subjects with histologically or cytologically confirmed advanced / metastatic or surgically unresectable solid tumors whose tumors are refractory to standard therapy
Measurable disease per RECIST v 1.1 (primary or metastatic disease)
ECOG performance status 0 - 1
Life expectancy of at least 3 months
Age ≥18 years
Signed, written Institutional Review Board (IRB) approved informed consent
A negative serum pregnancy test (for nonsterile women of child-bearing potential)
Acceptable liver function:
Acceptable renal function, defined as:
o Serum creatinine ≤ 1.5 ULN or Creatinine Clearance ≥ 50 mL/minute
Acceptable hematologic status:
Urinalysis with no clinically significant abnormalities
Acceptable coagulation status with partial thromboplastin time (PTT) and International Normalized Ratio (INR) ≤ 1.5 times upper limit of normal unless patient is on anticoagulants and has stable PTT and PT that are within normal therapeutic range for disease under management
Subject has adequate vitamin D level, as defined by serum total 25-Hydroxyvitamin D [25(OH)D] ≥ 20 to < 60 ng/mL. If subjects are below this threshold, they may receive vitamin D supplementation se per clinic dosing guidelines and may still be enrolled provided they are started on vitamin D supplementation
Completion of all previous treatments (including surgery, systemic chemotherapy, and radiotherapy) at least 3 weeks before screening
For men and women of child-producing potential, the use of effective contraceptive methods during the study
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
50 participants in 6 patient groups
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Central trial contact
Nadia Sheibani; Nadia Sheibani
Data sourced from clinicaltrials.gov
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