RECRUITING

A Study of EBC-129 in Advanced Solid Tumours

Conditions

Advanced Solid Tumours Antibody drug conjugates (ADCs)Recommended phase-2 dose (RP2D)Monomethyl auristatin E (MMAE)N-glycosylated CEACAM5/6

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

A Phase 1A/B Study To Evaluate The Safety And Tolerability Of EBC-129 As A Single Agent And In Combination With Pembrolizumab In Advanced Solid Tumours

Quick Facts

Study Start:2023-04-28

Study Completion:2026-06-11

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05701527

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	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

Inclusion Criteria

Exclusion 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

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

Contacts and Locations

Study Contact

Venkateshan Srirangam Prativadibhayankara, MD

CONTACT

+65 6407 4213

Venkateshan_Srirangam@eddc.sg

Veronica Diermayr

CONTACT

+65 6407 0706

Veronica_Diermayr@eddc.sg

Principal Investigator

Venkateshan Srirangam Prativadibhayankara, MD

STUDY_DIRECTOR

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

Study Locations (Sites)

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

Aurora, Colorado, 80045-2517

United States

UT MD Anderson Cancer Center

Houston, Texas, 77030

United States

Collaborators and Investigators

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

Venkateshan Srirangam Prativadibhayankara, MD, STUDY_DIRECTOR, EDDC (Experimental Drug Development Centre), A*STAR Research Entities

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-04-28

Study Completion Date2026-06-11

Study Record Updates

Study Start Date2023-04-28

Study Completion Date2026-06-11

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

Advanced Solid Tumours