Health TrialsbyHealthPanel

A Study of EBC-129 in Advanced Solid Tumours

ConditionAdvanced Solid Tumours
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorEDDC (Experimental Drug Development Centre), A*STAR Research Entities

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

98 Participants
are divided into 8 treatment groups

8

Treatment groups

See each treatment group below.

Group A: Part A-Cohort 1Experimental treatment 1 intervention
Group B: Part A-Cohort 2Experimental treatment 1 intervention
Group C: Part A-Cohort 3Experimental treatment 1 intervention
Group D: Part A-Cohort 4Experimental treatment 1 intervention
Group E: Part A-Cohort 5Experimental treatment 1 intervention
Group F: Part BExperimental treatment 2 interventions
Group G: Part CExperimental treatment 1 intervention
Group H: Part D: EBC-129Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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
2

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

Time frame
Approximately 2 years
3

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

Time frame
Approximately 2 years
4

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.

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

Secondary outcomes

1

Part A and Part B- 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.

Time frame
Day 1 through 12 cycles (each cycle is 21 days)
2

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

The percentage of patients who have a best overall response (BOR) of CR or PR in the first 12 weeks or who have demonstrated standard deviation (SD) for a minimum interval of 12 weeks following the start of treatment, will be determined based on RECIST.

Time frame
Approximately 3.3 years
3

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

The time from the date of first documented response until the first date of documented progression or death in the absence of disease progression.

Time frame
Approximately 3.3 years
4

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

The time from the date of the first dose until objective tumour progression.

Time frame
Approximately 3.3 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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

Lead sponsor

Parexel

Collaborator

Source ClinicalTrials.gov
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