Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCSD
Dates
study started
estimated completion

Description

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.

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

Details

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.

Keywords

Solid Tumor Relapsed Solid Neoplasm Refractory Tumor Neoplasms STI-6643

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • 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

Locations

  • University of California, San Diego accepting new patients
    San Diego California 92093 United States
  • NEXT Oncology - Austin accepting new patients
    Austin Texas 78758 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Sorrento Therapeutics, Inc.
ID
NCT04900519
Phase
Phase 1
Study Type
Interventional
Last Updated