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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04900519
Recruitment Status : Recruiting
First Posted : May 25, 2021
Last Update Posted : January 17, 2023
Sponsor:
Information provided by (Responsible Party):
Sorrento Therapeutics, Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Solid Tumor Relapsed Solid Neoplasm Refractory Tumor Biological: STI-6643 Phase 1

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 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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : November 24, 2021
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : March 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Safety

Arms and Interventions
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Arm Intervention/treatment
Experimental: STI-6643
STI-6643 will be provided in a single use 10-mL high borosilicate type 1 glass vial at a concentration of 500mg/10 mL (50 mg/mL) administered intravenously weekly for 4 weeks, then biweekly for Cycles 2 and up.
 Biological: STI-6643
Anti-CD47 human monoclonal antibody


Outcome Measures
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Primary Outcome Measures :
  1. Safety of STI-6643 [ Time Frame: Baseline through study completion at up to approximately 31 months ]
    Safety as assessed by incidence of adverse events, SAEs, DLTs, and clinically significant changes in safety lab results


Secondary Outcome Measures :
  1. Overall response rate [ Time Frame: Day 1 through study completion at up to approximately 31 months ]
    Overall response rate

  2. Duration of response [ Time Frame: Day 1 through study completion at up to approximately 31 months ]
    Duration of response

  3. STI-6643 receptor occupancy [ Time Frame: Day 1 through Day 22 ]
    STI-6643 receptor occupancy

  4. Anti-drug antibodies directed to STI-6643 [ Time Frame: Day 1 through Day 15 ]
    Anti-drug antibodies directed to STI-6643

  5. PK parameters [ Time Frame: Day 1 through Day 22 ]
    Evaluate the pharmacokinetics of STI-6643


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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:

    1. Absolute neutrophil count (ANC) ≥ 1500/mm3
    2. Platelets ≥ 100,000/mm3
    3. Hemoglobin ≥ 12 g/dL (in the absence of transfusion over the prior 2 weeks)
    4. AST/SGOT ≤ 2.5 x ULN (≤ 5 x ULN if known liver involvement)
    5. ALT/SGPT ≤ 2.5 x ULN (≤ 5 x ULN if known liver involvement)
    6. Total bilirubin ≤ 2.0 x ULN (unless diagnosis of Gilbert's syndrome in which case < 3.0 times ULN)
    7. Serum creatinine ≤ 2.0 x ULN or estimated GFR ≥ 45 mL/min (per Cockcroft- Gault equation)

  • If residual treatment related toxicity from prior therapy:

    1. Treatment related toxicity resolved to ≤ Grade 1 (alopecia excepted), or
    2. 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 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:

    1. Congestive heart failure (NYHA classification ≥ 3) within 6 months of the 1st dose of STI-6643
    2. Unstable angina pectoris
    3. ≤ 6 months from myocardial infarction and the 1st dose of STI-6643
    4. Arrhythmias (other than atrial fibrillation) requiring ongoing treatment
    5. QTcF interval > 480 msec (using Fridericia's formula)
    6. 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04900519


Contacts
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Contact: Mike Royal, MD (858) 203-4100 ext 4146 mroyal@sorrentotherapeutics.com

Locations
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United States, California
University of California, San Diego Not yet recruiting
San Diego, California, United States, 92093
Contact: Sandip Patel, MD         
United States, South Dakota
Sanford Health Recruiting
Sioux Falls, South Dakota, United States, 57104
Contact: Staci Vogel    605-328-1368    staci.vogel@sanfordhealth.org   
Principal Investigator: Steven Powell, MD         
United States, Texas
NEXT Oncology - Austin Completed
Austin, Texas, United States, 78758
Mary Crowley Cancer Research Recruiting
Dallas, Texas, United States, 75230
Contact: Timothy Eamma    214-658-1947    TEamma@marycrowley.org   
Principal Investigator: Reva Schneider, MD         
United States, Virginia
Virginia Cancer Specialists Recruiting
Fairfax, Virginia, United States, 22031
Contact: Carrie Friedman, RN       carrie.friedman@usoncology.com   
Principal Investigator: Alexander Spira, MD         
Sponsors and Collaborators
Sorrento Therapeutics, Inc.
Investigators
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Study Director: Mike Royal, MD Sorrento Therapeutics, Inc.
More Information
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Responsible Party: Sorrento Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT04900519    
Other Study ID Numbers: 47MAB-ADVCA-101
First Posted: May 25, 2021    Key Record Dates
Last Update Posted: January 17, 2023
Last Verified: January 2023

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sorrento Therapeutics, Inc.:
solid tumor
Additional relevant MeSH terms:
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Neoplasms