RECRUITING

A Study of SPX-303, a Bispecific Antibody Targeting LILRB2 and PD-L1 in Patients With Solid Tumors

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Part 1 of this study is an open-label, dose-escalation, and safety expansion study of an anti-LILRB2 / anti-PD-L1 bispecific antibody SPX- 303 in patients with solid tumors. Part 2 of this study is an indication-specific dose expansion study of SPX-303.

Official Title

A Phase 1, Open-label Study to Evaluate Safety, Tolerability, and Pharmacokinetics of an Anti-LILRB2 / PD-L1 Bispecific Antibody SPX- 303 in Patients With Solid Tumors

Quick Facts

Study Start:2024-03-20

Study Completion:2027-09

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06259552

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Males and females ≥18 years of age who comprehend, are not incarcerated, are willing and able to provide consent by signing an ICF, and able to comply with scheduled visits, treatment schedule, and laboratory tests, including other requirements for the study 2. Histologically or cytologically documented locally advanced or metastatic solid tumor malignancy 3. Patients who have progressed on or after prior therapy and who are not eligible for available treatment options 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 5. Has at least 1 measurable lesion per RECIST 1.1 criteria 6. Recovery from previous treatment related adverse events (TRAEs) to allow safety evaluations of SPX-303. Previous TRAEs include adverse drug reactions, and consequences of radiation, surgery, and other therapeutic modalities 7. Adequate hepatic function; bilirubin ≤1.5x upper limit of normal (ULN) (except for patients with Gilbert syndrome: ≤ 3xULN), aspartate aminotransferase (AST), and alanine aminotransferase (ALT) ≤2.5 x ULN (≤5 x ULN if liver metastases present). 8. Adequate renal function as calculated (e.g. Cockroft Gault) creatine clearance (CrCl) ≥ 30 mL/min or 24-hour urine CrCl ≥ 30 mL/min. 9. Adequate hematological function: absolute neutrophil count (ANC) ≥1 x 10\^9/L; platelets ≥75 x 10\^9/L, hemoglobin ≥9 g/dL. 10. Patients with well controlled HIV infection (ie CD4+ count \>350 cells/uL and viral copies less than 400/mL after at least 4 weeks of ART) are eligible for the trial. 11. Adequate coagulation function: INR, PT and aPPT ≤ 1.5x ULN except for patients on anti-coagulation as long as PT, aPPT, or INR are within intended range. 12. Adequate cardiac function: Left Ventricular Ejection Fraction (LVEF) ≥ 45% by multi-gated acquisition (MUGA) or echocardiography (ECHO) scan. 13. Fridericia-corrected QT interval (QTcF) ≤480 msec. 14. Women of childbearing potential must have a negative pregnancy test and must agree to use of 2 different methods of acceptable contraception from screening until 4 months after the last dose of study drug. Acceptable methods of contraception are defined as those that result, alone or in combination, in a low failure rate (ie, less than 1% per year) when used consistently and correctly, such as surgical sterilization, an intrauterine device, hormonal contraception in combination with a barrier method or abstinence). 15. Males who are sexually active with a female partner of childbearing potential must agree to use a barrier contraception (eg, condom with spermicidal foam/gel/film/cream/suppository) from screening until 4 months following the last dose of study drug, in addition to their female partner using either an intrauterine device or hormonal contraception and continuing until 4 months following the last dose of study drug. This criterion may be waived for male patients who have had a vasectomy \>6 months before signing the ICF.	1. History of prior malignancy, except for adequately treated in situ cancer, basal cell, or squamous cell skin cancer, or other cancers (eg, breast, prostate) for which the patient has been disease free for at least 3 years. Prostate cancer patients on active surveillance are eligible. 2. Active brain or leptomeningeal metastasis. Except patients with known brain metastases if they have been treated and MRI shows no evidence of progression for at least 8 weeks and require less than 10 mg/day prednisone/prednisolone or equivalent. 3. Treatment with anti neoplastic therapy ≤ 28 days or ≤ 5× elimination half life, whichever is shorter, before the first dose of study drug. 4. Major surgery requiring general anesthesia ≤ 28 days prior to dosing. 5. History of permanent discontinuation of prior IO therapy due to irAE. 6. Prior treatment targeting ILT2 and/or ILT4 or targeting HLA G. 7. Live or live attenuated vaccine ≤ 28days prior to dosing. 8. Immunosuppressive systemic medication, except topical corticosteroids or systemic corticosteroids at a dose level of ≤ 10 mg/d of prednisone/prednisolone or equivalent. Note: patients with adrenal insufficiency requiring hormonal replacement may receive higher dose of steroids. 9. Prior solid organ or bone marrow transplantation (except cornea transplantation). 10. History of clinically significant cardiovascular events (e.g. DVT ≤ 6 months, PE ≤ 12 months, MI or hospitalization for CHF ≤ 12 months, bleeding disorder or bleeding event ≤ 6 months, current clinically significant arrhythmia or unstable angina pectoris, current uncontrolled history of cerebrovascular accident in the past 6 months, current uncontrolled hypertension).

Inclusion Criteria

Exclusion Criteria

1. Males and females ≥18 years of age who comprehend, are not incarcerated, are willing and able to provide consent by signing an ICF, and able to comply with scheduled visits, treatment schedule, and laboratory tests, including other requirements for the study
2. Histologically or cytologically documented locally advanced or metastatic solid tumor malignancy
3. Patients who have progressed on or after prior therapy and who are not eligible for available treatment options
4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
5. Has at least 1 measurable lesion per RECIST 1.1 criteria
6. Recovery from previous treatment related adverse events (TRAEs) to allow safety evaluations of SPX-303. Previous TRAEs include adverse drug reactions, and consequences of radiation, surgery, and other therapeutic modalities
7. Adequate hepatic function; bilirubin ≤1.5x upper limit of normal (ULN) (except for patients with Gilbert syndrome: ≤ 3xULN), aspartate aminotransferase (AST), and alanine aminotransferase (ALT) ≤2.5 x ULN (≤5 x ULN if liver metastases present).
8. Adequate renal function as calculated (e.g. Cockroft Gault) creatine clearance (CrCl) ≥ 30 mL/min or 24-hour urine CrCl ≥ 30 mL/min.
9. Adequate hematological function: absolute neutrophil count (ANC) ≥1 x 10\^9/L; platelets ≥75 x 10\^9/L, hemoglobin ≥9 g/dL.
10. Patients with well controlled HIV infection (ie CD4+ count \>350 cells/uL and viral copies less than 400/mL after at least 4 weeks of ART) are eligible for the trial.
11. Adequate coagulation function: INR, PT and aPPT ≤ 1.5x ULN except for patients on anti-coagulation as long as PT, aPPT, or INR are within intended range.
12. Adequate cardiac function: Left Ventricular Ejection Fraction (LVEF) ≥ 45% by multi-gated acquisition (MUGA) or echocardiography (ECHO) scan.
13. Fridericia-corrected QT interval (QTcF) ≤480 msec.
14. Women of childbearing potential must have a negative pregnancy test and must agree to use of 2 different methods of acceptable contraception from screening until 4 months after the last dose of study drug. Acceptable methods of contraception are defined as those that result, alone or in combination, in a low failure rate (ie, less than 1% per year) when used consistently and correctly, such as surgical sterilization, an intrauterine device, hormonal contraception in combination with a barrier method or abstinence).
15. Males who are sexually active with a female partner of childbearing potential must agree to use a barrier contraception (eg, condom with spermicidal foam/gel/film/cream/suppository) from screening until 4 months following the last dose of study drug, in addition to their female partner using either an intrauterine device or hormonal contraception and continuing until 4 months following the last dose of study drug. This criterion may be waived for male patients who have had a vasectomy \>6 months before signing the ICF.

1. History of prior malignancy, except for adequately treated in situ cancer, basal cell, or squamous cell skin cancer, or other cancers (eg, breast, prostate) for which the patient has been disease free for at least 3 years. Prostate cancer patients on active surveillance are eligible.
2. Active brain or leptomeningeal metastasis. Except patients with known brain metastases if they have been treated and MRI shows no evidence of progression for at least 8 weeks and require less than 10 mg/day prednisone/prednisolone or equivalent.
3. Treatment with anti neoplastic therapy ≤ 28 days or ≤ 5× elimination half life, whichever is shorter, before the first dose of study drug.
4. Major surgery requiring general anesthesia ≤ 28 days prior to dosing.
5. History of permanent discontinuation of prior IO therapy due to irAE.
6. Prior treatment targeting ILT2 and/or ILT4 or targeting HLA G.
7. Live or live attenuated vaccine ≤ 28days prior to dosing.
8. Immunosuppressive systemic medication, except topical corticosteroids or systemic corticosteroids at a dose level of ≤ 10 mg/d of prednisone/prednisolone or equivalent. Note: patients with adrenal insufficiency requiring hormonal replacement may receive higher dose of steroids.
9. Prior solid organ or bone marrow transplantation (except cornea transplantation).
10. History of clinically significant cardiovascular events (e.g. DVT ≤ 6 months, PE ≤ 12 months, MI or hospitalization for CHF ≤ 12 months, bleeding disorder or bleeding event ≤ 6 months, current clinically significant arrhythmia or unstable angina pectoris, current uncontrolled history of cerebrovascular accident in the past 6 months, current uncontrolled hypertension).

Contacts and Locations

Study Contact

SparX Biotech

CONTACT

847-739-6251

SPX-303@sparxbio.com

Principal Investigator

Guidong Zhu

STUDY_CHAIR

SparX Biotech

Study Locations (Sites)

Mayo Clinic Arizona

Phoenix, Arizona, 85054

United States

HonorHealth Research and Innovation Institute

Scottsdale, Arizona, 85258

United States

Mayo Clinic Florida

Jacksonville, Florida, 32224

United States

Mayo Clinic Rochester

Rochester, Minnesota, 55905

United States

Collaborators and Investigators

Sponsor: SparX Biotech(Jiangsu) Co., Ltd.

Guidong Zhu, STUDY_CHAIR, SparX Biotech

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-03-20

Study Completion Date2027-09

Study Record Updates

Study Start Date2024-03-20

Study Completion Date2027-09

Terms related to this study

Keywords Provided by Researchers

Solid Tumor

Additional Relevant MeSH Terms

Solid Tumor
HNSCC
RCC
CRC