A Phase 1A/B Study To Evaluate The Safety And Tolerability Of EBC-129 As A Single Agent And In Combination With Pembrolizumab In Advanced Solid Tumours
EDDC (Experimental Drug Development Centre), A*STAR Research Entities
Summary
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
Description
This study is a prospective, open label study which is divided into 4 parts. Part A will be dose escalation segment to identify the maximum tolerated dose (MTD) and the recommended phase 2 dose (RP2D) of EBC-129 monotherapy. Part B will be dose escalation segment to identify the MTD and RP2D of EBC-129 in combination with pembrolizumab. Part C (dose expansion cohort) will be performed in an expanded cohort of patients with advanced solid malignancies at the RP2D of EBC-129 as a monotherapy identified in the dose escalation segment, Part A. Part D (Dose Fractionation Cohort) will be perform…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Male or female patients ≥18 years (US) or ≥21 years (Singapore) old 2. Body weight within ≥40 kg - ≤100 kg during Parts A and B, and ≤120 kg during all other parts of the study 3. 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 4. Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 2 for Part A and 0-1 for Parts B, C and D 5. Hepatic function and adequate renal function, as per protocol standa…
Interventions
- DrugEBC-129
EBC-129 will be administered on Day 1 of each 21-Day cycle (Parts A, B, and C), and two doses starting from Day 1 for 21-day cycle and three doses starting from Day 1 for 28-day cycle (Part D) via a 30-120-minute intravenous (IV) fusion.
- DrugPembrolizumab
Pembrolizumab will be administered at the dose of 200 mg IV every 21 days.
Locations (5)
- University of Colorado Hospital (UCH) - University of Colorado Cancer Center (UCCC) - Neuroendocrine Tumor CenterAurora, Colorado
- UT MD Anderson Cancer CenterHouston, Texas
- National University Hospital - Medical OncologySingapore, South West
- National Cancer Centre SingaporeSingapore, South West
- Taipei Veterans General HospitalTaipei, Taipei