Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT06259552

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

Led by SparX Biotech(Jiangsu) Co., Ltd. · Updated on 2024-09-24

232

Participants Needed

4

Research Sites

180 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Males and females 18 years of age or older who can understand and consent and comply with study requirements
  • Histologically or cytologically confirmed locally advanced or metastatic solid tumor malignancy
  • Disease progression after prior therapy and ineligible or declining available treatment options
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • At least one measurable lesion according to RECIST 1.1 criteria
  • Recovery from prior treatment-related adverse events to allow safety assessment
  • Adequate liver function: bilirubin ≤1.5x upper limit of normal (ULN) (≤3x ULN if Gilbert syndrome), AST and ALT ≤2.5x ULN (≤5x ULN if liver metastases present)
  • Adequate kidney function: creatinine clearance ≥30 mL/min
  • Adequate blood counts: ANC ≥1 x 10^9/L; platelets ≥75 x 10^9/L; hemoglobin ≥9 g/dL
  • Well-controlled HIV infection with CD4+ count >350 cells/µL and viral load <400/mL after at least 4 weeks of ART
  • Adequate coagulation function: INR, PT, aPPT ≤1.5x ULN, except for patients on anticoagulation with values within intended range
  • Adequate cardiac function: left ventricular ejection fraction ≥45% by MUGA or echocardiogram
  • Fridericia-corrected QT interval ≤480 msec
  • Women of childbearing potential with negative pregnancy test and agreement to use two forms of contraception from screening until 4 months after last dose
  • Sexually active males with female partners of childbearing potential must use barrier contraception plus partner using effective contraception from screening until 4 months after last dose (waiver allowed for vasectomized males >6 months)
Not Eligible

You will not qualify if you...

  • History of prior malignancy except adequately treated in situ cancer, basal or squamous cell skin cancer, or other cancers disease-free for at least 3 years; prostate cancer patients on active surveillance are eligible
  • Active brain or leptomeningeal metastases, except treated brain metastases with no progression for at least 8 weeks and requiring less than 10 mg/day prednisone or equivalent
  • Anti-neoplastic therapy within 28 days or less than five elimination half-lives before first study dose
  • Major surgery requiring general anesthesia within 28 days prior to dosing
  • History of discontinuation of prior immuno-oncology therapy due to immune-related adverse events
  • Prior treatment targeting ILT2, ILT4, or HLA G
  • Live or live attenuated vaccine within 28 days prior to dosing
  • Use of systemic immunosuppressive medications except low-dose corticosteroids ≤10 mg/day prednisone or equivalent; hormonal replacement for adrenal insufficiency allowed
  • Prior solid organ or bone marrow transplantation except cornea transplantation
  • History of significant cardiovascular events within specified recent time frames including deep vein thrombosis, pulmonary embolism, myocardial infarction, congestive heart failure, bleeding disorders, arrhythmia, unstable angina, cerebrovascular accident, or uncontrolled hypertension

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 4 locations

1

Mayo Clinic Arizona

Phoenix, Arizona, United States, 85054

Actively Recruiting

2

HonorHealth Research and Innovation Institute

Scottsdale, Arizona, United States, 85258

Actively Recruiting

3

Mayo Clinic Florida

Jacksonville, Florida, United States, 32224

Actively Recruiting

4

Mayo Clinic Rochester

Rochester, Minnesota, United States, 55905

Actively Recruiting

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Research Team

S

SparX Biotech

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

2

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