A Study of EBC-129 in Advanced Solid Tumours

Launched by EDDC (EXPERIMENTAL DRUG DEVELOPMENT CENTRE), A*STAR RESEARCH ENTITIES · Jan 18, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called EBC-129 for patients with advanced solid tumors, which are types of cancer that have spread or cannot be surgically removed. The trial aims to find out how safe EBC-129 is when given alone and when combined with another medication called pembrolizumab. The study is currently recruiting participants aged 18 and older who have tumors that have not responded to standard treatments and who meet certain health criteria.

To be eligible for the trial, participants should be in relatively good health, with specific requirements related to their body weight and organ function. They should have tumors that are advanced and have not responded to other therapies. Participants will receive the study medication and will be monitored for side effects and overall health. It's important to note that certain people, such as those with active autoimmune diseases or recent surgeries, may not be able to join the study. If you're considering participating, you'll need to provide a tissue sample from your tumor, which helps researchers understand how the treatment works.

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Eligibility criteria

• 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 standard
• • 6. Adequate bone marrow function as per protocol standard
• Exclusion Criteria:
• • 1. 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
• • 2. Has received investigational or anti-cancer therapy within 4 weeks (28 days) prior to starting study drug
• • 3. Is receiving any concomitant anti-cancer therapy
• • 4. Known severe hypersensitivity to E coli-derived products or filgrastim or peg-filgrastim and have significant allergies to such biological products
• • 5. Has clinically active brain metastases
• • 6. Has received prior radiation therapy
• • 7. Has received prophylactic administration of haematopoietic colony stimulating factors within 4 weeks (28 days) prior to starting study drug
• • 8. 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 prohibited medications listed in the concomitant and other treatments section of the protocol
• • 9. Pregnancy or breast feeding
• 10. For patients receiving pembrolizumab:
• • 1. Has an active autoimmune disease that has required systemic treatment in the past 2 years
• • 2. 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 mandated (any Grade 4 event and Grade 3 events of pneumonitis, hepatitis, and nephritis). Also, patients without formal contraindication due to previous irAE with any immune checkpoint inhibitor (approved or investigational) are not eligible if the AE has not resolved to grade 1 or better and/or still requires steroids (\>10 mg of prednisone equivalent per day) for ongoing management.
• • 3. 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 myocarditis are excluded from enrolment into pembrolizumab-containing cohorts
• • 11. Has had a major surgical procedure within 4 weeks (28 days) from starting the study drug
• • 12. 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 keratopathy
• • 13. Active infection including HIV, Hepatitis B or Hepatitis C