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New treatment option for Solid Tumor
Official title A Study of SPX-303, a Bispecific Antibody Targeting LILRB2 and PD-L1 in Patients With Solid Tumors
ClinicalTrials.gov ID: NCT06259552
What this study is testing
What is SPX- 303 Injection, a bispecific anti-LILRB2 / anti-PD-L1 Antibody?
SPX- 303 Injection, a bispecific anti-LILRB2 / anti-PD-L1 Antibody is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for solid tumor.
Also referred to as SPX-303.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Histologically or cytologically documented locally advanced or metastatic solid tumor malignancy
- Patients who have progressed on or after prior therapy and who are not eligible for available treatment options
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Has at least 1 measurable lesion per RECIST 1.1 criteria
You likely can't join if
- History of prior malignancy, except for adequately treated in situ cancer, basal cell, or squamous cell skin cancer, or other cancers (eg, breast...
- Active brain or leptomeningeal metastasis. Except patients with known brain metastases if they have been treated and MRI shows no evidence of...
- Treatment with anti neoplastic therapy ≤ 28 days or ≤ 5× elimination half life, whichever is shorter, before the first dose of study drug.
- Major surgery requiring general anesthesia ≤ 28 days prior to dosing.
- History of permanent discontinuation of prior IO therapy due to irAE.
- Prior treatment targeting ILT2 and/or ILT4 or targeting HLA G.
See the full eligibility criteria
- 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...
- Histologically or cytologically documented locally advanced or metastatic solid tumor malignancy
- Patients who have progressed on or after prior therapy and who are not eligible for available treatment options
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Has at least 1 measurable lesion per RECIST 1.1 criteria
- 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...
- 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...
- Adequate renal function as calculated (e.g. Cockroft Gault) creatine clearance (CrCl) ≥ 30 mL/min or 24-hour urine CrCl ≥ 30 mL/min.
- Adequate hematological function: absolute neutrophil count (ANC) ≥1 x 10\^9/L; platelets ≥75 x 10\^9/L, hemoglobin ≥9 g/dL.
- 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.
- 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.
- Adequate cardiac function: Left Ventricular Ejection Fraction (LVEF) ≥ 45% by multi-gated acquisition (MUGA) or echocardiography (ECHO) scan.
- Fridericia-corrected QT interval (QTcF) ≤480 msec.
- 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...
- 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...
- 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...
- 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...
- Treatment with anti neoplastic therapy ≤ 28 days or ≤ 5× elimination half life, whichever is shorter, before the first dose of study drug.
- Major surgery requiring general anesthesia ≤ 28 days prior to dosing.
- History of permanent discontinuation of prior IO therapy due to irAE.
- Prior treatment targeting ILT2 and/or ILT4 or targeting HLA G.
- Live or live attenuated vaccine ≤ 28days prior to dosing.
- 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...
- Prior solid organ or bone marrow transplantation (except cornea transplantation).
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Phoenix, Arizona, United States
- Scottsdale, Arizona, United States
- Jacksonville, Florida, United States
- Rochester, Minnesota, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Phoenix, Arizona, United States; Scottsdale, Arizona, United States; Jacksonville, Florida, United States; Rochester, Minnesota, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.