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Advanced Solid TumoursPhase 1NCT05701527

A Study of EBC-129 in Advanced Solid Tumours

A Phase 1 study testing EBC-129 and Pembrolizumab in people with Advanced Solid Tumours, run by EDDC (Experimental Drug Development Centre), A*STAR Research Entities at 5 sites in 3 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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 Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Solid Tumours
What is being tested?
EBC-129 and Pembrolizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
98 participants
Where
5 sitesin 3 countries
Study dates
28 Apr 2023to 24 Dec 2026
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 16Show fewer
  • 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
  • Active infection including HIV, Hepatitis B or Hepatitis C

Trial locations and contacts

5 sites in 3 countries. Contact the study team or a site near you to ask about taking part.

Venkateshan Srirangam Prativadibhayankara, MD contact

+65 6407 4213

Venkateshan_Srirangam@eddc.sg

Veronica Diermayr contact

+65 6407 0706

Veronica_Diermayr@eddc.sg

5 sites in 3 countries

United States2 sites, 2 recruiting

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

    Aurora, Colorado, 80045-2517

    Sunnie Kim

    Recruiting

  • UT MD Anderson Cancer Center

    Houston, Texas, 77030

    Meric-Bernstam Funda

    Recruiting

Other trials in United States

Singapore2 sites, 2 recruiting

  • National University Hospital - Medical Oncology

    Singapore, South West, 119228

    Yong Wei Peng

    Recruiting

  • National Cancer Centre Singapore

    Singapore, South West, 168583

    Ng Matthew

    Recruiting

Other trials in Singapore

Taiwan1 site, 1 recruiting

  • Taipei Veterans General Hospital

    Taipei, Taipei, 11217

    Not yet recruiting

Other trials in Taiwan

About this study

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

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

Read the 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.

Being tested
EBC-129, Pembrolizumab
Keywords
Advanced solid tumours, Antibody drug conjugates (ADCs), Recommended phase-2 dose (RP2D), Monomethyl auristatin E (MMAE), N-glycosylated CEACAM5/6

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EBC-129Drug

    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.

  • PembrolizumabDrug

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

Study groups in NCT05701527
Study groupRoleWhat they receive
Part A-Cohort 1ExperimentalPatients will be administered Dose 1 of EBC-129 as a monotherapy.
Receives: Drug: EBC-129
Part A-Cohort 2ExperimentalPatients will be administered Dose 2 of EBC-129 as a monotherapy.
Receives: Drug: EBC-129
Part A-Cohort 3ExperimentalPatients will be administered Dose 3 of EBC-129 as a monotherapy.
Receives: Drug: EBC-129
Part A-Cohort 4ExperimentalPatients will be administered Dose 4 of EBC-129 as a monotherapy.
Receives: Drug: EBC-129
Part A-Cohort 5ExperimentalPatients will be administered Dose 5 of EBC-129 as a monotherapy.
Receives: Drug: EBC-129
Part BExperimentalPatients will be administered three different dose levels of EBC-129 in combination with a fixed dose of pembrolizumab.
Receives: Drug: EBC-129; Drug: Pembrolizumab
Part CExperimentalPatients will be administered the highest dose of EBC-129 as a monotherapy at the RP2D determined in Part A of the study.
Receives: Drug: EBC-129
Part D: EBC-129ExperimentalPatients will be administered EBC-129 as a monotherapy as per two-dose or three-dose per cycle regimen.
Receives: Drug: EBC-129

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 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)

    Measured: Approximately 2 years

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

    Measured: 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.

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

  5. Part D- ORR

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

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

Secondary outcomes (23)

  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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: Approximately 3.3 years

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

    The time from the date of first dose until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the patient withdraws from therapy or receives another anti-cancer therapy prior to progression.

    Measured: Approximately 3.3 years

  6. Part A, Part B, Part C and Part D- Overall Survival (OS)

    The time from the date of the first dose until death due to any cause.

    Measured: Approximately 3.3 years

  7. Part A, Part B, Part C and Part D- Maximum Plasma Concentration (Cmax) of EBC-129

    Measured: Parts A, B and C: Cycle 1, 2, 3, and Cycle 4 (each cycle is 21 days); Part D: Cycle 1 (each cycle is 21 or 28 days)

  8. Part A, Part B, Part C and Part D- Trough Concentration (Ctrough) of EBC-129

    Measured: Parts A, B and C: Cycle 1, 2, 3, and Cycle 4 (each cycle is 21 days); Part D: Cycle 1 (each cycle is 21 or 28 days)

  9. Part A, Part B, Part C and Part D- Area under the curve (AUC) of EBC-129

    Measured: Parts A, B, and C: Cycle 1 and Cycle 2 (each cycle is 21 days); Part D: Cycle 1 (each cycle is 21 or 28 days)

  10. Part A, Part B, Part C and Part D- Maximum plasma concentration at steady state (Cmax_ss) of EBC-129

    Measured: Parts A, B, and C: Day 1 through 12 cycles (each cycle is 21 days); Part D: Day 1 through 12 cycles (each cycle is 21 or 28 days)

  11. Part A, Part B, Part C and Part D- Trough concentration at steady state (Ctrough,ss) of EBC-129

    Measured: Parts A, B, and C: Day 1 through 12 cycles (each cycle is 21 days); Part D: Day 1 through 12 cycles (each cycle is 21 or 28 days)

  12. Part A, Part B, Part C and Part D- Area under the curve at steady state (AUC_ss) of EBC-129

    Measured: Parts A, B, and C: Day 1 through 12 cycles (each cycle is 21 days); Part D: Day 1 through 12 cycles (each cycle is 21 or 28 days)

  13. Part A, Part B, Part C and Part D- Accumulation ratios of EBC-129

    Measured: Parts A, B, and C: Day 1 through 12 cycles (each cycle is 21 days); Part D: Day 1 through 12 cycles (each cycle is 21 or 28 days)

  14. Part A, Part B, Part C and Part D- Time to maximum plasma concentration (Tmax) of EBC-129

    Measured: Parts A, B, and C: Day 1 through 12 cycles (each cycle is 21 days); Part D: Day 1 through 12 cycles (each cycle is 21 or 28 days)

  15. Part A, Part B, Part C and Part D- Half-life (t1/2) of EBC-129

    Measured: Parts A, B, and C: Day 1 through 12 cycles (each cycle is 21 days); Part D: Day 1 through 12 cycles (each cycle is 21 or 28 days)

  16. Part B- Cmax of Pemrolizumab

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

  17. Part B- Ctrough of Pemrolizumab

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

  18. Part B- AUC of Pemrolizumab

    Measured: Cycle 1 and 2 (each cycle is 21 days)

  19. Part B- Tmax of Pemrolizumab

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

  20. Part B- t1/2 of Pemrolizumab

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

  21. Part A, Part B, Part C and Part D- Number of patients with detectable Anti-drug antibodies (ADAs)

    Measured: Parts A, B, and C: Day 1 through 12 cycles (each cycle is 21 days); Part D: Day 1 through 12 cycles (each cycle is 21 or 28 days)

  22. Part A, Part B, Part C and Part D- Number of patients with neutralising antibodies

    Measured: Parts A, B, and C: Day 1 through 12 cycles (each cycle is 21 days); Part D: Day 1 through 12 cycles (each cycle is 21 or 28 days)

  23. Part A- Comparison of tumour responses

    The tumour responses (RECIST 1.1) will be compared between preselected patients and not pre-selected/not expressing the antigen when centrally assessed by immunohistochemistry (IHC).

    Measured: Approximately 1.8 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2023
  2. Study start28 Apr 2023
  3. Primary completion24 Dec 2026 (estimated)
  4. Study completion24 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
98 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05701527
Sponsor's protocol ID
EBC-129-01
Status last verified
Feb 2026
First submitted
18 Jan 2023
Last updated
5 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing EBC-129 and Pembrolizumab in people with Advanced Solid Tumours, run by EDDC (Experimental Drug Development Centre), A*STAR Research Entities at 5 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 5 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States, Singapore, Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Venkateshan Srirangam Prativadibhayankara, MD (+65 6407 4213, Venkateshan_Srirangam@eddc.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the 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). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05701527.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2026.

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