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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 : July 5, 2022
Sponsor:
Information provided by (Responsible Party):
Sorrento Therapeutics, Inc.

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 dose limiting toxicity evaluated over the initial 28 days of STI-6643 administration.

The schedule of STI-6643 administration will be weekly for the initial 4 weeks of a 5-week cycle and then every 2 weeks thereafter (i.e., starting with Cycle 2) of a 4-week cycle. Subjects will continue to receive STI-6643 in the absence of progression or unacceptable toxicity. Subjects with minimal toxicity will have the option of decreasing the frequency of their clinic visits during later cycles.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 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 21, 2021
Estimated Primary Completion Date : March 2024
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Safety

Arm Intervention/treatment
Experimental: STI-6643
5, 10, 20, 30, 40, 50, or 60 mg/kg administered intravenously Q1W during Cycle 1, then Q2W for Cycles 2 and up
Biological: STI-6643
Anti-CD47 human monoclonal antibody




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 of the last cycle (up to 31 months, each cycle is 28 days) ]
    Anti-drug antibodies directed to STI-6643



Information from the National Library of Medicine

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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

Key Inclusion Criteria:

  • ECOG Performance Status <= 2
  • Histologically cytologically confirmed solid tumor
  • 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
  • Willingness to comply with the study schedule and all study requirements

Key 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 C1D1
  • ≤ 28 days from prior irradiation (≤ 7 days from limited field irradiation for control of symptoms) and C1D1
  • 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

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 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: Steven Powell, MD         
United States, Texas
NEXT Oncology - Austin Recruiting
Austin, Texas, United States, 78758
Contact: Cynthia DeLeon    210-580-9521    cdeleon@nextoncology.com   
Principal Investigator: Andrae Vandross, MD         
Mary Crowley Cancer Research Recruiting
Dallas, Texas, United States, 75230
Contact: James Strauss, MD    972-566-3000    referral@marycrowley.org   
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.
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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: July 5, 2022
Last Verified: June 2022

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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