A Study of SPX-303, a Bispecific Antibody Targeting LILRB2 and PD-L1 in Patients With Solid Tumors
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorSparX Biotech(Jiangsu) Co., Ltd.
About this trial
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.
Eligibility criteria
Qualifiers
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
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
Disqualifiers
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.
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.
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.
Trial design
Treatments tested in this trial
- SPX- 303 Injection, a bispecific anti-LILRB2 / anti-PD-L1 Antibody
Treatment groups
232 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov