Actively Recruiting
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
Led by SparX Biotech(Jiangsu) Co., Ltd. · Updated on 2024-09-24
232
Participants Needed
4
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating SPX-303, a bispecific antibody targeting LILRB2 and PD-L1, in patients with advanced solid tumors who have progressed after prior treatments and are not eligible or decline other options. This open-label Phase 1 study aims to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of SPX-303, including identifying the maximum tolerated dose or maximum administered dose. The study consists of two parts: Part 1 is a dose escalation and safety expansion phase where SPX-303 is given intravenously every 3 weeks to patients with measurable disease. Part 2 focuses on dose expansion in specific solid tumor types using the recommended Phase 2 dose established in Part 1 to further evaluate anti-tumor activity. Both parts involve close monitoring of treatment effects and side effects. Participants will undergo regular visits for assessments including monitoring for dose-limiting toxicities, adverse events, response rates, disease control, progression-free survival, and drug levels in the body. Safety evaluations will continue for several years, with treatment-related adverse events tracked for up to 3.5 years. The study duration and follow-up periods vary by participant and study phase.
CONDITIONS
Brief Title
A Study of SPX-303, a Bispecific Antibody Targeting LILRB2 and PD-L1 in Patients With Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males and females aged 18 years or older who understand the study, can consent, and comply with visits and tests
- Histologically or cytologically confirmed locally advanced or metastatic solid tumor
- Disease progression after prior therapy and not eligible or declined other treatments
- ECOG performance status of 0 or 1
- At least one measurable lesion per RECIST 1.1 criteria
- Recovery from previous treatment-related adverse events allowing safety evaluation
- Adequate liver function with bilirubin 61.5x ULN (or 63x ULN if Gilbert syndrome), AST and ALT 62.5x ULN (or 65x ULN if liver metastases)
- Adequate kidney function with creatinine clearance 630 mL/min
- Adequate blood counts: ANC 61 x 10^9/L, platelets 675 x 10^9/L, hemoglobin 69 g/dL
- Well-controlled HIV infection with CD4+ count >350 cells/uL and viral load <400/mL after ART
- Adequate coagulation parameters: INR, PT, aPPT 61.5x ULN unless on anticoagulants within intended range
- Adequate heart function: LVEF 645% by MUGA or echocardiogram
- QTcF interval 6480 msec
- Women of childbearing potential must have negative pregnancy test and use two forms of contraception until 4 months after last dose
- Sexually active males with female partners must use barrier contraception and partner use of effective contraception until 4 months after last dose (waived if vasectomy >6 months)
You will not qualify if you...
- History of prior malignancy except treated in situ cancers, basal or squamous skin cancer, or other cancers disease free for 3+ years; prostate cancer on surveillance allowed
- Active brain or leptomeningeal metastasis unless treated with no progression for 8 weeks and low steroid use
- Anti-cancer therapy within 28 days or 5 half-lives before study dosing
- Major surgery requiring general anesthesia within 28 days prior to dosing
- Previous immune checkpoint inhibitor therapy stopped permanently due to immune-related adverse events
- Prior treatments targeting ILT2, ILT4, or HLA G
- Live or live attenuated vaccine within 28 days before dosing
- Use of systemic immunosuppressive medication except low-dose corticosteroids (<=10 mg/day prednisone or equivalent)
- History of solid organ or bone marrow transplant (except cornea)
- Significant cardiovascular events within specified recent timeframes including DVT, PE, MI, CHF hospitalization, bleeding disorders, arrhythmias, unstable angina, stroke, or uncontrolled hypertension within past 6-12 months depending on event type
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 3 years
Participants receive SPX-303 intravenously every 3 weeks to evaluate safety, tolerability, and preliminary anti-tumor efficacy.
Visits every 3 weeks for dosing and assessments
Duration - Up to 3.5 years
Participants are monitored for treatment-related adverse events and long-term outcomes after treatment ends.
Periodic visits for safety and efficacy assessments
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
Research Team
S
SparX Biotech
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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