Evaluating EMB-09 for advanced or metastatic solid tumors
A First-in-human, Phase I Trial of EMB-09, a Bispecific Antibody Targeting PD-L1 and OX-40 in Patients With Advanced or Metastatic Solid Tumors
This study is testing a new drug called EMB-09 to see if it is safe and effective for people with advanced or metastatic solid tumors.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Shanghai EpimAb Biotherapeutics Co., Ltd. Industry-sponsored |
| Drugs / interventions | radiation |
| Locations | 4 sites (Frankston and 3 other locations) |
| Trial ID | NCT05263180 on ClinicalTrials.gov |
What this trial studies
This phase I, multi-center, open-label study aims to assess the safety and tolerability of EMB-09 in patients with advanced or metastatic solid tumors. The study will determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) while also evaluating pharmacokinetics, pharmacodynamics, immunogenicity, and the drug's anti-tumor activity. Participants will receive multiple doses of EMB-09, and their responses will be monitored according to established criteria.
Who should consider this trial
Good fit: Ideal candidates include patients with histologically confirmed advanced or metastatic solid tumors who have failed standard treatments.
Not a fit: Patients with early-stage tumors or those who have not yet undergone standard therapies may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors who have exhausted standard therapies.
How similar studies have performed: Other studies involving bispecific antibodies have shown promise in treating solid tumors, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Willing and able to provide signed and dated informed consent prior to any study-related procedures and willing and able to comply with all study procedures. * Phase I subjects: 1. Patients with histologically or cytologically confirmed locally advanced/metastatic solid tumors including but not limited to melanoma, non-small cell lung cancer (NSCLC), triple negative breast cancer (TNBC), head and neck squamous cell carcinoma (HNSCC), nasopharyngeal cancer (NPC), hepatocellular carcinoma (HCC), gastric cancer (GC), endometrium cancer (EC), ovarian cancer (OC), renal cell carcinoma (RCC) and small cell lung cancer (SCLC), colorectal cancer (CRC). 2. Patients who have failed (progressed on, or are intolerant of) standard therapies or no available standard treatment 3. Measurable or evaluable disease per RECIST v1.1. * Patients must provide archival tumor, or a fresh tumor biopsy will be required if archival tumor sample is not available. Archival tumor sample must be taken \<2 years prior to screening, otherwise a fresh tumor biopsy at screening is required. * ECOG performance status 0 or 1; life expectancy \> 3 months. * Adequate organ function to participate in the trial. * Recovery from adverse events (AEs) related to prior anticancer therapy. * Highly effective contraception Exclusion Criteria: * Patients who have active autoimmune disease or history of autoimmune disease * History of severe irAE. * History of severe allergic reactions * Use of systemic corticosteroids. * Symptomatic central nervous system metastases. * Patients with cardiac dysfunction * Uncontrolled diabetes mellitus with hemoglobin A1c \> 8% (via medical history) * Prior treatment with TNFRSF agonists including OX40, CD27, CD137 (4-1BB), CD357 (GITR), CD40. * Anticancer therapy or radiation \< 5 half-lives or 4 weeks (whichever is shorter) prior to study treatment; * Current or history of idiopathic pulmonary fibrosis, interstitial lung disease, or organizing pneumonia. * Concurrent malignancy \< 5 years prior to entry. * Patients with active infections. * Major surgery \< 4 weeks or minor surgery \< 2 weeks prior to study treatment. * Live virus vaccines \< 30 days prior to screening * Pregnant or breast-feeding females * Any investigational agents or study drugs from a previous clinical study within 30 days of the first dose of study treatment. * Any other serious underlying medical conditions * Abuse of alcohol, cannabis-derived products, or other drugs.
Where this trial is running
Frankston and 3 other locations
- Peninsula and South Eastern Haematology & Oncology Group — Frankston, Australia (Recruiting)
- GenesisCareNorthShore — Leonards Hill, Australia (Recruiting)
- Blacktown Hospital — Sydney, Australia (Recruiting)
- Fuscc — Shanghai, China (Recruiting)
Study contacts
- Study coordinator: Shuqi Zeng, MD.
- Email: shqzeng@epimab.com
- Phone: +86-21-61043299
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.