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

NCT04900519 | Unknown Phase 1 FDA Drug

• 1 other identifier: 47MAB-ADVCA-101
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 5

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.

Conditions

Solid Tumor; Relapsed Solid Neoplasm; Refractory Tumor

Keywords

solid tumor

Outcome Measures

Primary Outcomes (1)

• Safety of STI-6643

  Safety as assessed by incidence of adverse events, SAEs, DLTs, and clinically significant changes in safety lab results

  Baseline through study completion at up to approximately 31 months

Secondary Outcomes (5)

• Overall response rate

  Day 1 through study completion at up to approximately 31 months

• Duration of response

  Day 1 through study completion at up to approximately 31 months

• STI-6643 receptor occupancy

  Day 1 through Day 22

• Anti-drug antibodies directed to STI-6643

  Day 1 through Day 15

• PK parameters

  Day 1 through Day 22

Study Arms (1)

STI-6643

EXPERIMENTAL

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

Interventions

STI-6643 BIOLOGICAL

Anti-CD47 human monoclonal antibody

STI-6643

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Absolute neutrophil count (ANC) ≥ 1500/mm3
• Platelets ≥ 100,000/mm3
• Hemoglobin ≥ 12 g/dL (in the absence of transfusion over the prior 2 weeks)
• AST/SGOT ≤ 2.5 x ULN (≤ 5 x ULN if known liver involvement)
• ALT/SGPT ≤ 2.5 x ULN (≤ 5 x ULN if known liver involvement)
• Total bilirubin ≤ 2.0 x ULN (unless diagnosis of Gilbert's syndrome in which case \< 3.0 times ULN)

You may not qualify 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 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

Sponsors & Collaborators

• Sorrento Therapeutics, Inc.: lead

Study Sites (5)

University of California, San Diego

San Diego, California, 92093, United States

NOT YET RECRUITING

Sanford Health

Sioux Falls, South Dakota, 57104, United States

RECRUITING

NEXT Oncology - Austin

Austin, Texas, 78758, United States

COMPLETED

Mary Crowley Cancer Research

Dallas, Texas, 75230, United States

RECRUITING

Virginia Cancer Specialists

Fairfax, Virginia, 22031, United States

RECRUITING

MeSH Terms

Conditions

Neoplasms

Study Officials

• Mike Royal, MD

  Sorrento Therapeutics, Inc.

  STUDY DIRECTOR

Central Study Contacts

Mike Royal, MD

CONTACT

(858) 203-4100; mroyal@sorrentotherapeutics.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2021
• First Posted: May 25, 2021
• Study Start: November 24, 2021
• Primary Completion: December 1, 2024
• Study Completion: March 1, 2025
• Last Updated: January 17, 2023

Record last verified: 2023-01

Locations

US (5)