Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion 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.
Exclusion Criteria:
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).
Note: Other protocol defined Inclusion/Exclusion Criteria may apply.
Eligibility last updated 3/21/2024. Questions regarding updates should be directed to the study team contact.