Status:
UNKNOWN
Study of the Safety and Efficacy of STI-6643 in Subjects With Advanced Solid Tumors
Lead Sponsor:
Sorrento Therapeutics, Inc.
Conditions:
Solid Tumor
Relapsed Solid Neoplasm
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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.
Detailed 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 deter...
Eligibility Criteria
Inclusion
- 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:
- Absolute neutrophil count (ANC) ≥ 1500/mm3
- Platelets ≥ 100,000/mm3
- Hemoglobin ≥ 12 g/dL (in the absence of transfusion over the prior 2 weeks)
- AST/SGOT ≤ 2.5 x ULN (≤ 5 x ULN if known liver involvement)
- ALT/SGPT ≤ 2.5 x ULN (≤ 5 x ULN if known liver involvement)
- Total bilirubin ≤ 2.0 x ULN (unless diagnosis of Gilbert's syndrome in which case \< 3.0 times ULN)
- Serum creatinine ≤ 2.0 x ULN or estimated GFR ≥ 45 mL/min (per Cockcroft- Gault equation)
- If residual treatment related toxicity from prior therapy:
- Treatment related toxicity resolved to ≤ Grade 1 (alopecia excepted), or
- Treatment related toxicity resolved to ≤ Grade 2 with prior approval of the Medical Monitor
- 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
- 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:
- Congestive heart failure (NYHA classification ≥ 3) within 6 months of the 1st dose of STI-6643
- Unstable angina pectoris
- ≤ 6 months from myocardial infarction and the 1st dose of STI-6643
- Arrhythmias (other than atrial fibrillation) requiring ongoing treatment
- QTcF interval \> 480 msec (using Fridericia's formula)
- Uncontrolled hypertension (i.e., systolic BP \> 180 mmHg or diastolic BP \> 100
- 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.
Key Trial Info
Start Date :
November 24 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2025
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04900519
Start Date
November 24 2021
End Date
March 1 2025
Last Update
January 17 2023
Active Locations (5)
Enter a location and click search to find clinical trials sorted by distance.
1
University of California, San Diego
San Diego, California, United States, 92093
2
Sanford Health
Sioux Falls, South Dakota, United States, 57104
3
NEXT Oncology - Austin
Austin, Texas, United States, 78758
4
Mary Crowley Cancer Research
Dallas, Texas, United States, 75230