A Phase 1 Study of EBC-129 in Advanced Solid Tumours

• Status: Not yet recruiting
• Trial end date: 2025-05-04
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: EDDC (Experimental Drug Development Centre), A*STAR Research Entities
• Collaborator: Parexel
• Treatments: Pembrolizumab

Criteria

Inclusion Criteria:

1. Male or female subjects ≥18 years (USA) or ≥21 years (Singapore) old

2. Body weight within ≥40 kg - ≤100 kg

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

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 previously received 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 CYP3A inhibitors within 14 days prior to the first dose of study drug or subjects 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) USPI/SmPC, 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, subjects 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. Active infection including HIV, Hepatitis B or Hepatitis C