A Phase 1 Study of EBC-129 in Advanced Solid Tumours

This study will assess the safety and tolerability of EBC-129 as a single agent and in combination with pembrolizumab in patients with advanced solid tumours

Inclusion Criteria:Male or female subjects ≥18 years (USA) or ≥21 years (Singapore) oldBody weight within ≥40 kg - ≤100 kgDemonstrated progression of a locally advanced unresectable or metastatic solid tumour with no alternative standard-of-care therapeutic option with a proven clinical benefit, or are intolerant to these therapiesEastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 2Hepatic function and adequate renal function, as per protocol standardAdequate bone marrow function as per protocol standardExclusion Criteria:Unable or not willing to provide tumour tissue sample (from archival tissue or de-novo biopsy) unless if there is a significant risk for the patient to undergo biopsyHas received investigational or anti-cancer therapy within 4 weeks (28 days) prior to starting study drugIs receiving any concomitant anti-cancer therapyKnown severe hypersensitivity to E coli-derived products or previously received filgrastim or peg-filgrastim and have significant allergies to such biological productsHas clinically active brain metastasesHas received prior radiation therapyHas received prophylactic administration of haematopoietic colony stimulating factors within 4 weeks (28 days) prior to starting study drugPatients concurrently using any strong P-glycoprotein (P-gp) inducers/inhibitors or strong CYP3A inhibitors within 14 days prior to the first dose of study drug or subjects that use restricted or prohibited medications listed in the concomitant and other treatments section of the protocolPregnancy or breast feedingFor patients receiving pembrolizumab:Has an active autoimmune disease that has required systemic treatment in the past 2 yearsPatients who, according to the currently approved Keytruda (pembrolizumab) USPI/SmPC, had an immune-related adverse event (irAE) for which permanent discontinuation is mandated (any grade 4 event and grade 3 events of pneumonitis, hepatitis, and nephritis). Also, subjects without formal contraindication due to previous irAE with any immune checkpoint inhibitor (approved or investigational) are not eligible if the AE has not resolved to grade 1 or better and/or still requires steroids (>10 mg of prednisone equivalent per day) for ongoing managementPatients with a history of pneumonitis/interstitial lung disease, patients who received live vaccines within 30 days of enrolment, and patients who discontinued prior immune checkpoint inhibitors due to Grade 2 myocarditis are excluded from enrolment into pembrolizumab-containing cohortsHas had a major surgical procedure within 4 weeks (28 days) from starting the study drugActive infection including HIV, Hepatitis B or Hepatitis C