Trials / Recruiting
RecruitingNCT05701527
A Study of EBC-129 in Advanced Solid Tumours
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
- Status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 98 (estimated)
- Sponsor
- EDDC (Experimental Drug Development Centre), A*STAR Research Entities · Other Government
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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 4 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. Part D (Dose Fractionation Cohort) will be performed in patients with advanced solid malignancies with cancer indications that have shown preliminary clinical activity in Part C.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | EBC-129 | 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. |
| DRUG | Pembrolizumab | Pembrolizumab will be administered at the dose of 200 mg IV every 21 days. |
Timeline
- Start date
- 2023-04-28
- Primary completion
- 2026-12-24
- Completion
- 2026-12-24
- First posted
- 2023-01-27
- Last updated
- 2026-02-05
Locations
5 sites across 3 countries: United States, Singapore, Taiwan
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05701527. Inclusion in this directory is not an endorsement.