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

  • STATUS
    Recruiting
  • End date
    Dec 2, 2022
  • participants needed
    24
  • sponsor
    Sorrento Therapeutics, Inc.
Updated on 2 December 2021

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.

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.

Details
Condition Relapsed Solid Neoplasm, Solid Tumors, Solid Neoplasm, Solid Tumour, Refractory Tumor, Solid Tumor
Treatment STI-6643
Clinical Study IdentifierNCT04900519
SponsorSorrento Therapeutics, Inc.
Last Modified on2 December 2021

Eligibility

Yes No Not Sure

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

Exclusion Criteria

Participating in any other interventional clinical study
Previous exposure to an anti-CD47 or SIRP antibody
days (or 5 half-lives if shorter) between of systemic anti-tumor treatment (e.g., chemotherapy, endocrine therapy, immunotherapy, cellular therapy) and C1D1
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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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