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

NCT ID: NCT04900519

Last Updated: 2023-01-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-24
• Study Completion Date: 2025-03-31

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.

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 priming dose identification (PDI) stage and therapeutic dose (TD) escalation (TDE) stage. Dose limiting toxicity evaluated over the initial 28 days of STI-6643 administration.

Conditions

Solid Tumor; Relapsed Solid Neoplasm; Refractory Tumor

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

STI-6643

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.

Group Type: EXPERIMENTAL

STI-6643

Intervention Type: BIOLOGICAL

Anti-CD47 human monoclonal antibody

Interventions

STI-6643

Anti-CD47 human monoclonal antibody

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• 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:

1. Absolute neutrophil count (ANC) ≥ 1500/mm3

2. Platelets ≥ 100,000/mm3

3. Hemoglobin ≥ 12 g/dL (in the absence of transfusion over the prior 2 weeks)

4. AST/SGOT ≤ 2.5 x ULN (≤ 5 x ULN if known liver involvement)

5. ALT/SGPT ≤ 2.5 x ULN (≤ 5 x ULN if known liver involvement)

6. Total bilirubin ≤ 2.0 x ULN (unless diagnosis of Gilbert's syndrome in which case < 3.0 times ULN)

7. Serum creatinine ≤ 2.0 x ULN or estimated GFR ≥ 45 mL/min (per Cockcroft- Gault equation)

• If residual treatment related toxicity from prior therapy:

1. Treatment related toxicity resolved to ≤ Grade 1 (alopecia excepted), or

2. Treatment related toxicity resolved to ≤ Grade 2 with prior approval of the Medical Monitor

• Willingness to comply with the study schedule and all study requirements
• [Females] Must be postmenopausal, surgically sterile, or agree to use adequate contraception (per Investigator) throughout the study and for a least 30 days following the last dose
• [Males] Must be surgically sterile or must agree to use adequate contraception (per Investigator) throughout the study and for at least 30 days following the last dose
• [Males] Willingness to refrain from donating sperm throughout the study and for at least 30 days following the last dose
• [Females] If of child-bearing potential, must have a negative serum pregnancy test

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 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
• Known HIV-positive with CD4+ cell counts < 350 cells/uL or a history of an AIDS defining opportunistic infection
• Known T-cell leukemia virus type 1 (HTLV1) infection, hepatitis B virus (HBV) or hepatitis C virus (HCV) viremia
• Significant risk for HBV reactivation (defined as HbsAg positive, HbcAb positive or HBV DNA positive)
• Detectable HCV RNA
• Pregnant or breast feeding
• History of clinically significant cardiovascular abnormalities including:

1. Congestive heart failure (NYHA classification ≥ 3) within 6 months of the 1st dose of STI-6643

2. Unstable angina pectoris

3. ≤ 6 months from myocardial infarction and the 1st dose of STI-6643

4. Arrhythmias (other than atrial fibrillation) requiring ongoing treatment

5. QTcF interval > 480 msec (using Fridericia's formula)

6. Uncontrolled hypertension (i.e., systolic BP > 180 mmHg or diastolic BP > 100

• Any condition, including the presence of laboratory abnormalities, that places the subject at an unacceptable risk if the subject was to participate in the study.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sorrento Therapeutics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mike Royal, MD

Role: STUDY_DIRECTOR

Sorrento Therapeutics, Inc.

Locations

University of California, San Diego

San Diego, California, United States

Site Status: NOT_YET_RECRUITING

Sanford Health

Sioux Falls, South Dakota, United States

Site Status: RECRUITING

NEXT Oncology - Austin

Austin, Texas, United States

Site Status: COMPLETED

Mary Crowley Cancer Research

Dallas, Texas, United States

Site Status: RECRUITING

Virginia Cancer Specialists

Fairfax, Virginia, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Mike Royal, MD

Role: CONTACT

mroyal@sorrentotherapeutics.com

(858) 203-4100 ext. 4146

Facility Contacts

Sandip Patel, MD

Role: primary

Staci Vogel

Role: primary

staci.vogel@sanfordhealth.org

605-328-1368

Timothy Eamma

Role: primary

TEamma@marycrowley.org

214-658-1947

Carrie Friedman, RN

Role: primary

carrie.friedman@usoncology.com

Other Identifiers

47MAB-ADVCA-101

Identifier Type: -

Identifier Source: org_study_id