A Study of EBC-129 in Advanced Solid Tumours

NCT05701527 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: EBC-129-01
• Study Type: interventional
• Target: 98
• Locations: 3 countries
• Sites: 5

Brief 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

Conditions

Advanced Solid Tumours

Keywords

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

Outcome Measures

Primary Outcomes (5)

• Part A, Part B, Part C and Part D- Number of patients with serious adverse events (SAEs) and treatment emergent adverse events (TEAEs)

  From pre-screening (≥28 days from planned date of treatment i.e. Day 1) until end of study (EOS i.e., 30 days from last dose). Approximately 2 years

• Part A, Part B and Part D- Determination of Maximum tolerated dose (MTD)

  Approximately 2 years

• Part A, Part B and Part D- Determination of the Recommended Phase 2 dose (RP2D)

  Approximately 2 years

• Part C- Objective response rate (ORR)

  The number (%) of patients with a best overall response of complete response (CR) or partial response (PR) per RECIST v1.1 as assessed by investigator.

  Day 1 through 12 cycles (each cycle is 21 days)

• Part D- ORR

  The number (%) of patients with a best overall response of CR or PR per RECIST v1.1 as assessed by investigator.

  Day 1 through 12 cycles (each cycle is 21 or 28 days)

Secondary Outcomes (23)

• Part A and Part B- ORR

  Day 1 through 12 cycles (each cycle is 21 days)

• Part A, Part B, Part C and Part D- Disease control rate (DCR)

  Approximately 3.3 years

• Part A, Part B, Part C and Part D- Duration of Response (DoR)

  Approximately 3.3 years

• Part A, Part B, Part C and Part D- Time to Progression (TTP)

  Approximately 3.3 years

• Part A, Part B, Part C and Part D- Progression Free Survival (PFS)

  Approximately 3.3 years

Study Arms (8)

Part A-Cohort 1

EXPERIMENTAL

Patients will be administered Dose 1 of EBC-129 as a monotherapy.

Drug: EBC-129

Part A-Cohort 2

EXPERIMENTAL

Patients will be administered Dose 2 of EBC-129 as a monotherapy.

Drug: EBC-129

Part A-Cohort 3

EXPERIMENTAL

Patients will be administered Dose 3 of EBC-129 as a monotherapy.

Drug: EBC-129

Part A-Cohort 4

EXPERIMENTAL

Patients will be administered Dose 4 of EBC-129 as a monotherapy.

Drug: EBC-129

Part A-Cohort 5

EXPERIMENTAL

Patients will be administered Dose 5 of EBC-129 as a monotherapy.

Drug: EBC-129

Part B

EXPERIMENTAL

Patients will be administered three different dose levels of EBC-129 in combination with a fixed dose of pembrolizumab.

Drug: EBC-129; Drug: Pembrolizumab

Part C

EXPERIMENTAL

Patients will be administered the highest dose of EBC-129 as a monotherapy at the RP2D determined in Part A of the study.

Drug: EBC-129

Part D: EBC-129

EXPERIMENTAL

Patients will be administered EBC-129 as a monotherapy as per two-dose or three-dose per cycle regimen.

Drug: EBC-129

Interventions

EBC-129 DRUG

EBC-129 will be administered on Day 1 of each 21-Day cycle (Parts A, B, and C), and two doses starting from Day 1 for 21-day cycle and three doses starting from Day 1 for 28-day cycle (Part D) via a 30-120-minute intravenous (IV) fusion.

Part A-Cohort 1; Part A-Cohort 2; Part A-Cohort 3; Part A-Cohort 4; Part A-Cohort 5; Part B; Part C; Part D: EBC-129

Pembrolizumab DRUG

Pembrolizumab will be administered at the dose of 200 mg IV every 21 days.

Part B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 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

You may not qualify 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 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 prohibited medications listed in the concomitant and other treatments section of the protocol
• 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 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.
• 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
• 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 keratopathy

Sponsors & Collaborators

• EDDC (Experimental Drug Development Centre), A*STAR Research Entities: lead
• Parexel: collaborator

Study Sites (5)

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

Aurora, Colorado, 80045-2517, United States

RECRUITING

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

National University Hospital - Medical Oncology

Singapore, South West, 119228, Singapore

RECRUITING

National Cancer Centre Singapore

Singapore, South West, 168583, Singapore

RECRUITING

Taipei Veterans General Hospital

Taipei, Taipei, 11217, Taiwan

NOT YET RECRUITING

MeSH Terms

Interventions

pembrolizumab

Study Officials

• Venkateshan Srirangam Prativadibhayankara, MD

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

  STUDY DIRECTOR

Central Study Contacts

Venkateshan Srirangam Prativadibhayankara, MD

CONTACT

+65 6407 4213; Venkateshan_Srirangam@eddc.sg

Veronica Diermayr

CONTACT

+65 6407 0706; Veronica_Diermayr@eddc.sg

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2023
• First Posted: January 27, 2023
• Study Start: April 28, 2023
• Primary Completion (Estimated): December 24, 2026
• Study Completion (Estimated): December 24, 2026
• Last Updated: February 5, 2026

Record last verified: 2026-02

Locations

US (2); SG (2); TW (1)