RECRUITING

Study of the Safety and Efficacy of STI-6643 in Subjects With Advanced Solid Tumors

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Conditions

Solid TumorRelapsed Solid NeoplasmRefractory Tumor

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

A Phase 1, Open-Label, Dose-Escalation Study of the Safety and Efficacy of STI-6643, an Anti-CD47 Human Monoclonal Antibody, in Subjects With Advanced Solid Tumors

Quick Facts

Study Start:2021-11-24
Study Completion:2025-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04900519

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Signed informed consent
  2. * Age ≥ 18 years
  3. * ECOG Performance Status ≤ 2
  4. * Histologically- or cytologically-confirmed solid tumor
  5. * Patient has relapsed, is refractory to, or intolerant of standard of care therapy
  6. * No available approved therapy that may provide clinical benefit (per Investigator)
  7. * Measurable or evaluable disease by RECISTv1.14
  8. * Life expectancy of \> 12 weeks (per Investigator)
  9. * Adequate laboratory parameters including:
  10. 1. Absolute neutrophil count (ANC) ≥ 1500/mm3
  11. 2. Platelets ≥ 100,000/mm3
  12. 3. Hemoglobin ≥ 12 g/dL (in the absence of transfusion over the prior 2 weeks)
  13. 4. AST/SGOT ≤ 2.5 x ULN (≤ 5 x ULN if known liver involvement)
  14. 5. ALT/SGPT ≤ 2.5 x ULN (≤ 5 x ULN if known liver involvement)
  15. 6. Total bilirubin ≤ 2.0 x ULN (unless diagnosis of Gilbert's syndrome in which case \< 3.0 times ULN)
  16. 7. Serum creatinine ≤ 2.0 x ULN or estimated GFR ≥ 45 mL/min (per Cockcroft- Gault equation)
  17. * If residual treatment related toxicity from prior therapy:
  18. 1. Treatment related toxicity resolved to ≤ Grade 1 (alopecia excepted), or
  19. 2. Treatment related toxicity resolved to ≤ Grade 2 with prior approval of the Medical Monitor
  20. * Willingness to comply with the study schedule and all study requirements
  21. * \[Females\] 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
  22. * \[Males\] 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
  23. * \[Males\] Willingness to refrain from donating sperm throughout the study and for at least 30 days following the last dose
  24. * \[Females\] If of child-bearing potential, must have a negative serum pregnancy test
  1. * Participating in any other interventional clinical study
  2. * Previous exposure to an anti-CD47 or SIRPα antibody
  3. * ≤ 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
  4. * ≤ 28 days from prior irradiation (≤ 7 days from limited field irradiation for control of symptoms) and the 1st dose of STI-6643
  5. * ≤ 28 days between major surgery (≤ 7 days from minor surgical procedures, no waiting period following central catheter placement)
  6. * ≤ 7 days between administration of G-CSF, GM-CSF, erythropoietin, thrombopoietin or IL11 and the 1st dose of STI-6643
  7. * ≤ 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)
  8. * ≤ 28 days between a live attenuated vaccine and the 1st dose of STI-6643
  9. * Known central nervous system (CNS) involvement with tumor (e.g., metastases, meningeal carcinomatosis)
  10. * Active second malignancy requiring ongoing systemic treatment
  11. * History of primary immunodeficiency disorders
  12. * History of active pulmonary tuberculosis
  13. * History of COVID-19 symptoms unless COVID-19 test negative ≤ 72 hours of the 1st dose of STI-6643
  14. * ≤ 12 weeks from an allogeneic hematopoietic stem cell transplant and C1D1 or active graft-versus-host disease (GvHD)
  15. * Active infection (e.g., bacterial, viral, fungal) requiring systemic treatment ≤ 72 hours of the 1st dose of STI-6643
  16. * Known HIV-positive with CD4+ cell counts \< 350 cells/uL or a history of an AIDS defining opportunistic infection
  17. * Known T-cell leukemia virus type 1 (HTLV1) infection, hepatitis B virus (HBV) or hepatitis C virus (HCV) viremia
  18. * Significant risk for HBV reactivation (defined as HbsAg positive, HbcAb positive or HBV DNA positive)
  19. * Detectable HCV RNA
  20. * Pregnant or breast feeding
  21. * History of clinically significant cardiovascular abnormalities including:
  22. 1. Congestive heart failure (NYHA classification ≥ 3) within 6 months of the 1st dose of STI-6643
  23. 2. Unstable angina pectoris
  24. 3. ≤ 6 months from myocardial infarction and the 1st dose of STI-6643
  25. 4. Arrhythmias (other than atrial fibrillation) requiring ongoing treatment
  26. 5. QTcF interval \> 480 msec (using Fridericia's formula)
  27. 6. Uncontrolled hypertension (i.e., systolic BP \> 180 mmHg or diastolic BP \> 100
  28. * 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.

Contacts and Locations

Study Contact

Mike Royal, MD
CONTACT
(858) 203-4100
mroyal@sorrentotherapeutics.com

Principal Investigator

Mike Royal, MD
STUDY_DIRECTOR
Sorrento Therapeutics, Inc.

Study Locations (Sites)

University of California, San Diego
San Diego, California, 92093
United States
Sanford Health
Sioux Falls, South Dakota, 57104
United States
NEXT Oncology - Austin
Austin, Texas, 78758
United States
Mary Crowley Cancer Research
Dallas, Texas, 75230
United States
Virginia Cancer Specialists
Fairfax, Virginia, 22031
United States

Collaborators and Investigators

Sponsor: Sorrento Therapeutics, Inc.

  • Mike Royal, MD, STUDY_DIRECTOR, Sorrento Therapeutics, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-11-24
Study Completion Date2025-03

Study Record Updates

Study Start Date2021-11-24
Study Completion Date2025-03

Terms related to this study

Keywords Provided by Researchers

  • solid tumor

Additional Relevant MeSH Terms

  • Solid Tumor
  • Relapsed Solid Neoplasm
  • Refractory Tumor