Testing EBC-129 for advanced solid tumors
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
PHASE1 · EDDC (Experimental Drug Development Centre), A*STAR Research Entities · NCT05701527
This study is testing a new treatment called EBC-129, alone and with another drug, to see how safe it is and if it can help people with advanced solid tumors.
Quick facts
| Phase | PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 98 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | EDDC (Experimental Drug Development Centre), A*STAR Research Entities (other gov) |
| Drugs / interventions | pembrolizumab, radiation, prednisone |
| Locations | 5 sites (Aurora, Colorado and 4 other locations) |
| Trial ID | NCT05701527 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and tolerability of EBC-129, both as a standalone treatment and in combination with pembrolizumab, for patients with advanced solid tumors. It consists of four parts: the first two parts focus on determining the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of EBC-129 alone and with pembrolizumab. The third part expands the cohort to assess EBC-129's effectiveness at the RP2D, while the fourth part investigates dose fractionation in patients showing preliminary clinical activity. The study aims to provide insights into the therapeutic potential of EBC-129 in this patient population.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 or older with advanced solid tumors that are locally advanced, unresectable, or metastatic, and who have no effective standard-of-care options.
Not a fit: Patients who have received investigational or anti-cancer therapy within the last 28 days or those unable to provide a tumor tissue sample may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could offer a new therapeutic option for patients with advanced solid tumors who have limited alternatives.
How similar studies have performed: While this approach is novel in its specific combination, similar studies involving antibody drug conjugates have shown promise in treating advanced solid tumors.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
1. Male or female patients ≥18 years (US) or ≥21 years (Singapore) old
2. Body weight within ≥40 kg - ≤100 kg during Parts A and B, and ≤120 kg during all other parts of the study
3. 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
4. Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 2 for Part A and 0-1 for Parts B, C and D
5. Hepatic function and adequate renal function, as per protocol standard
6. Adequate bone marrow function as per protocol standard
Exclusion Criteria:
1. 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
2. Has received investigational or anti-cancer therapy within 4 weeks (28 days) prior to starting study drug
3. Is receiving any concomitant anti-cancer therapy
4. Known severe hypersensitivity to E coli-derived products or filgrastim or peg-filgrastim and have significant allergies to such biological products
5. Has clinically active brain metastases
6. Has received prior radiation therapy
7. Has received prophylactic administration of haematopoietic colony stimulating factors within 4 weeks (28 days) prior to starting study drug
8. 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
9. Pregnancy or breast feeding
10. For patients receiving pembrolizumab:
1. Has an active autoimmune disease that has required systemic treatment in the past 2 years
2. 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.
3. 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
11. Has had a major surgical procedure within 4 weeks (28 days) from starting the study drug
12. 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
13. Active infection including HIV, Hepatitis B or Hepatitis C
Where this trial is running
Aurora, Colorado and 4 other locations
- University of Colorado Hospital (UCH) - University of Colorado Cancer Center (UCCC) - Neuroendocrine Tumor Center — Aurora, Colorado, United States (RECRUITING)
- UT MD Anderson Cancer Center — Houston, Texas, United States (RECRUITING)
- National University Hospital - Medical Oncology — Singapore, South West, Singapore (RECRUITING)
- National Cancer Centre Singapore — Singapore, South West, Singapore (RECRUITING)
- Taipei Veterans General Hospital — Taipei, Taipei, Taiwan (NOT_YET_RECRUITING)
Study contacts
- Study coordinator: Venkateshan Srirangam Prativadibhayankara, MD
- Email: Venkateshan_Srirangam@eddc.sg
- Phone: +65 6407 4213
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Advanced Solid Tumours, Advanced solid tumours, Antibody drug conjugates, Recommended phase-2 dose, Monomethyl auristatin E, N-glycosylated CEACAM5/6