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New treatment option for Advanced Solid Tumours
Official title A Study of EBC-129 in Advanced Solid Tumours
ClinicalTrials.gov ID: NCT05701527
What this study is testing
What is EBC-129?
EBC-129 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for advanced solid tumours.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 2 for Part A and 0-1 for Parts B, C and D
- Hepatic function and adequate renal function, as per protocol standard
You likely can't join if
- 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...
- 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
- Has clinically active brain metastases
- Has received prior radiation therapy
See the full eligibility criteria
- 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
- Hepatic function and adequate renal function, as per protocol standard
- Adequate bone marrow function as per protocol standard
- 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
- Has clinically active brain metastases
- Has received prior radiation therapy
- Has received prophylactic administration of haematopoietic colony stimulating factors within 4 weeks (28 days) prior to starting study drug
- Patients concurrently using any strong P-glycoprotein (P-gp) inducers/inhibitors or strong cytochrome P3A (CYP3A) inhibitors within 14 days prior to the first dose of study drug or patients that use restricted or...
- Pregnancy or breast feeding
- For patients receiving pembrolizumab:
- Has an active autoimmune disease that has required systemic treatment in the past 2 years
- Patients who, according to the currently approved Keytruda (pembrolizumab) US package insert (USPI)/summary of product characteristics, had an immune-related adverse event (irAE) for which permanent discontinuation is...
- Patients 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...
- Has had a major surgical procedure within 4 weeks (28 days) from starting the study drug
- Patients with active or chronic corneal disorders, with other active ocular conditions requiring ongoing therapy or with any clinically significant corneal disease that prevents adequate monitoring of drug-induced...
- Active infection including HIV, Hepatitis B or Hepatitis C
The study team makes the final eligibility decision.
Where it's taking place
- Aurora, Colorado, United States
- Houston, Texas, United States
- Singapore, South West, Singapore
- Taipei, Taipei, Taiwan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Aurora, Colorado, United States; Houston, Texas, United States; Singapore, South West, Singapore; Taipei, Taipei, Taiwan. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.