A Study of EBC-129 in Advanced Solid Tumours

Conditions

• Advanced Solid Tumours

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

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

Study Details

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

Key Dates

Start date

Apr 28, 2023

Status verified

Feb 2026

Primary completion

Dec 24, 2026

Completion

Dec 24, 2026

Study Design

Enrollment

98 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Part A-Cohort 1
  Patients will be administered Dose 1 of EBC-129 as a monotherapy.
• Experimental: Part A-Cohort 2
  Patients will be administered Dose 2 of EBC-129 as a monotherapy.
• Experimental: Part A-Cohort 3
  Patients will be administered Dose 3 of EBC-129 as a monotherapy.
• Experimental: Part A-Cohort 4
  Patients will be administered Dose 4 of EBC-129 as a monotherapy.
• Experimental: Part A-Cohort 5
  Patients will be administered Dose 5 of EBC-129 as a monotherapy.
• Experimental: Part B
  Patients will be administered three different dose levels of EBC-129 in combination with a fixed dose of pembrolizumab.
• Experimental: Part C
  Patients will be administered the highest dose of EBC-129 as a monotherapy at the RP2D determined in Part A of the study.
• Experimental: Part D: EBC-129
  Patients will be administered EBC-129 as a monotherapy as per two-dose or three-dose per cycle regimen.

Primary Outcome Measure

Part A, Part B, Part C and Part D- Number of patients with serious adverse events (SAEs) and treatment emergent adverse events (TEAEs) [ Time Frame: 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 ]

Central Contacts

• Venkateshan Srirangam Prativadibhayankara, MD
  +65 6407 4213
  [email protected]
• Veronica Diermayr
  +65 6407 0706
  [email protected]

Locations (2)

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