Study of the Safety and Efficacy of STI-6643 in Subjects With Advanced Solid Tumors
Study Details
Study Description
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 |
|---|---|---|
|
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.
Study Design
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures
- Safety of STI-6643 [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
- Overall response rate [Day 1 through study completion at up to approximately 31 months]
Overall response rate
- Duration of response [Day 1 through study completion at up to approximately 31 months]
Duration of response
- STI-6643 receptor occupancy [Day 1 through Day 22]
STI-6643 receptor occupancy
- Anti-drug antibodies directed to STI-6643 [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
Eligibility Criteria
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
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≤ 28 days from prior irradiation (≤ 7 days from limited field irradiation for control of symptoms) and C1D1
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of California, San Diego | San Diego | California | United States | 92093 |
| 2 | Sanford Health | Sioux Falls | South Dakota | United States | 57104 |
| 3 | NEXT Oncology - Austin | Austin | Texas | United States | 78758 |
| 4 | Mary Crowley Cancer Research | Dallas | Texas | United States | 75230 |
| 5 | Virginia Cancer Specialists | Fairfax | Virginia | United States | 22031 |
Sponsors and Collaborators
- Sorrento Therapeutics, Inc.
Investigators
- Study Director: Mike Royal, MD, Sorrento Therapeutics, Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 47MAB-ADVCA-101