Health Trials

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 groups

8

Treatment groups

See each treatment group below.

Locations

5
Singapore
National Cancer Centre Singapore168583, SingaporeSouth West, Singapore
National University Hospital - Medical Oncology119228, SingaporeSouth West, Singapore
Taiwan
Taipei Veterans General Hospital11217, TaipeiTaipei, Taiwan
United States
University of Colorado Hospital (UCH) - University of Colorado Cancer Center (UCCC) - Neuroendocrine Tumor Center80045-2517, AuroraColorado, United States

Sponsors and collaborators

EDDC (Experimental Drug Development Centre), A*STAR Research Entities

Lead sponsor

Parexel

Collaborator

Source ClinicalTrials.gov