A Study of EBC-129 in Advanced Solid Tumours
ConditionAdvanced Solid Tumours
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorEDDC (Experimental Drug Development Centre), A*STAR Research Entities
About this trial
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
Eligibility criteria
Qualifiers
Male or female patients ≥18 years (US) or ≥21 years (Singapore) old
Body weight within ≥40 kg - ≤100 kg during Parts A and B, and ≤120 kg during all other parts of the study
Demonstrated 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 therapies
Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 2 for Part A and 0-1 for Parts B, C and D
Disqualifiers
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 biopsy
Has received investigational or anti-cancer therapy within 4 weeks (28 days) prior to starting study drug
Is receiving any concomitant anti-cancer therapy
Known severe hypersensitivity to E coli-derived products or filgrastim or peg-filgrastim and have significant allergies to such biological products
Trial design
Treatments tested in this trial
- EBC-129
- Pembrolizumab
Treatment groups
98 Participants
are divided into 8 treatment groups8
Treatment groupsSee each treatment group below.
Sponsors and collaborators
Source ClinicalTrials.gov