A Study of EBC-129 in Advanced Solid Tumours

Trial Title: A Study of EBC-129 in Advanced Solid Tumours

NCT ID: NCT05701527

Condition: Advanced Solid Tumours

Conditions: Official terms:
Neoplasms
Pembrolizumab

Conditions: Keywords:
Advanced solid tumours
Antibody drug conjugates (ADCs)
Recommended phase-2 dose (RP2D)
Monomethyl auristatin E (MMAE)
N-glycosylated CEACAM5/6

Study type: Interventional

Study phase: Phase 1

Overall status: Recruiting

Study design:

Allocation: Non-Randomized

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: EBC-129
Description: EBC-129 will be administered on Day 1 of each 21-Day cycle via a 30-120-minute intravenous (IV) fusion.
Arm group label: Part A-Cohort 1
Arm group label: Part A-Cohort 2
Arm group label: Part A-Cohort 3
Arm group label: Part A-Cohort 4
Arm group label: Part A-Cohort 5
Arm group label: Part B
Arm group label: Part C

Intervention type: Drug
Intervention name: Pembrolizumab
Description: Pembrolizumab will be administered at the dose of 200 mg IV every 21 days.
Arm group label: Part B

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

Detailed description: This study is a prospective, open label study which is divided into 3 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.

Criteria for 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 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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: University of Colorado Hospital (UCH) - University of Colorado Cancer Center (UCCC) - Neuroendocrine Tumor Center

Address:
City: Aurora
Zip: 80045-2517
Country: United States

Status: Recruiting

Investigator:
Last name: Lentz Robert
Email: Principal Investigator

Facility:
Name: UT MD Anderson Cancer Center

Address:
City: Houston
Zip: 77030
Country: United States

Status: Recruiting

Investigator:
Last name: Meric-Bernstam Funda
Email: Principal Investigator

Facility:
Name: National University Hospital - Medical Oncology

Address:
City: Singapore
Zip: 119228
Country: Singapore

Status: Recruiting

Investigator:
Last name: Yong Wei Peng
Email: Principal Investigator

Facility:
Name: National Cancer Centre Singapore

Address:
City: Singapore
Zip: 168583
Country: Singapore

Status: Recruiting

Investigator:
Last name: Ng Matthew
Email: Principal Investigator

Start date: April 28, 2023

Completion date: June 11, 2026

Lead sponsor:
Agency: EDDC (Experimental Drug Development Centre), A*STAR Research Entities
Agency class: Other

Collaborator:
Agency: Parexel
Agency class: Industry

Source: EDDC (Experimental Drug Development Centre), A*STAR Research Entities

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05701527