Actively Recruiting
A Phase 1A/B Study to Evaluate Safety and Tolerability of EBC-129 Alone and with Pembrolizumab in Advanced Solid Tumours
Led by EDDC (Experimental Drug Development Centre), A*STAR Research Entities · Updated on 2026-02-05
98
Participants Needed
5
Research Sites
N/A
Total Duration
On this page
Sponsors
E
EDDC (Experimental Drug Development Centre), A*STAR Research Entities
Lead Sponsor
P
Parexel
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and tolerability of a drug called EBC-129, used alone and with pembrolizumab, in patients with advanced solid tumors. This open-label, phase 1a/b study is divided into four parts to identify safe dosing levels and to explore the drug's effects in different patient groups. It aims to find the maximum tolerated dose and recommended phase 2 dose for EBC-129 alone and combined with pembrolizumab, targeting patients who have limited treatment options due to advanced cancer. The study includes four parts: Part A tests escalating doses of EBC-129 alone to find safe dosing; Part B tests escalating doses of EBC-129 combined with pembrolizumab; Part C expands on Part A using the recommended dose of EBC-129 alone in more patients; and Part D evaluates dosing schedules in patients with cancer types showing early responses. EBC-129 is given intravenously on Day 1 of each 21-day cycle in Parts A, B, and C, with varying dosing schedules in Part D. Pembrolizumab is administered every 21 days at a fixed dose. Participants will undergo monitoring for adverse events and treatment responses over several cycles, with assessments including tumor response rates and drug concentration measurements. The study tracks serious and treatment-emergent adverse events from before treatment until 30 days after the last dose, with outcome measures extending up to approximately 3.3 years. This includes evaluating tumor control, duration of response, progression, survival rates, and drug levels in the blood to understand the safety and effects of the treatments.
CONDITIONS
Brief Title
A Study of EBC-129 in Advanced Solid Tumours
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female patients aged 18 years or older (US) or 21 years or older (Singapore)
- Body weight between 40 kg and 100 kg for Parts A and B, and up to 120 kg for other parts
- Have a progressing locally advanced unresectable or metastatic solid tumour with no standard treatment option or intolerance to such therapies
- Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less for Part A, and 0 to 1 for Parts B, C, and D
- Adequate liver and kidney function as defined by the study protocol
- Adequate bone marrow function as defined by the study protocol
You will not qualify if you...
- Unable or unwilling to provide a tumor tissue sample unless biopsy poses significant risk
- Received investigational or anti-cancer therapy within 4 weeks before starting study drug
- Receiving any other anti-cancer therapy concurrently
- Known severe allergies to E coli-derived products, filgrastim, or peg-filgrastim
- Clinically active brain metastases
- Prior radiation therapy
- Received prophylactic colony stimulating factors within 4 weeks before starting study drug
- Using strong P-glycoprotein inducers/inhibitors or strong CYP3A inhibitors within 14 days before first dose
- Pregnant or breastfeeding
- For pembrolizumab recipients: active autoimmune disease needing systemic treatment in past 2 years, prior severe immune-related adverse events, history of pneumonitis or myocarditis, recent live vaccines
- Major surgery within 4 weeks before starting study drug
- Active or chronic corneal or ocular conditions affecting drug monitoring
- Active infections including HIV, Hepatitis B, or Hepatitis C
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 cycles of 21 or 28 days each
Participants receive EBC-129 as a monotherapy or in combination with pembrolizumab in 21-day cycles, or with a two- or three-dose per cycle regimen in 21- or 28-day cycles depending on the study part.
Treatment visits every 21 days or every 28 days depending on regimen
Duration - Approximately 2 years
Participants are monitored for safety and treatment effects for approximately 30 days after the last dose and up to 2 years for adverse events and further outcomes.
Periodic visits for safety and outcome assessments
Trial Site Locations
Total: 5 locations
1
University of Colorado Hospital (UCH) - University of Colorado Cancer Center (UCCC) - Neuroendocrine Tumor Center
Aurora, Colorado, United States, 80045-2517
Actively Recruiting
2
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
3
National University Hospital - Medical Oncology
Singapore, South West, Singapore, 119228
Actively Recruiting
4
National Cancer Centre Singapore
Singapore, South West, Singapore, 168583
Actively Recruiting
5
Taipei Veterans General Hospital
Taipei, Taipei, Taiwan, 11217
Not Yet Recruiting
Research Team
V
Venkateshan Srirangam Prativadibhayankara, MD
V
Veronica Diermayr
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
8
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