Testing EMB-07 for advanced solid tumors and lymphoma
A First-in-human, Phase I, Open-Label Study of EMB-07, a Bi-specific Antibody Anti-CD3 and Receptor Tyrosine Kinase-like Orphan Receptor 1 (ROR1) in Patients With Locally Advanced/Metastatic Solid Tumors or Relapse/Refractory Lymphoma
This study is testing a new treatment called EMB-07 to see if it can safely help people with advanced solid tumors and lymphoma.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | EpimAb Biotherapeutics (Suzhou)Co., Ltd. Industry-sponsored |
| Drugs / interventions | radiation |
| Locations | 10 sites (Frankston, Victoria and 9 other locations) |
| Trial ID | NCT05607498 on ClinicalTrials.gov |
What this trial studies
This phase I, multicenter, open-label trial evaluates the safety and tolerability of EMB-07, a bispecific antibody targeting CD3 and ROR1, in patients with locally advanced or metastatic solid tumors and relapse/refractory lymphoma. The study aims to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) while also assessing pharmacokinetics, pharmacodynamics, immunogenicity, and anti-tumor activity. Participants will receive EMB-07 and be monitored for responses and side effects throughout the trial.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with specific types of advanced solid tumors or relapse/refractory lymphoma that have not responded to standard therapies.
Not a fit: Patients with early-stage cancers or those for whom standard therapies are still effective 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 and lymphoma who have limited or no effective treatment alternatives.
How similar studies have performed: Other studies involving bispecific antibodies have shown promise, but this specific approach with EMB-07 is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. 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. 2. Male or female, and aged ≥ 18 years 3. Treatment group A: Patients with histologically or cytologically locally advanced unresectable or metastatic solid tumors limiting to triple-negative breast cancer, lung adenocarcinoma, ovarian cancer, pancreatic cancer, colorectal cancer, gastric cancer, prostate cancer, bladder cancer, and uterus cancer. Treatment group B: Patients with histologically or cytologically relapse/refractory lymphoma limiting to chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), mantle cell lymphoma (MCL) and diffuse large B cell lymphoma (DLBCL). 4. Treatment group A: Standard therapies do not exist, or are no longer effective, or are not tolerable or accessible to the patient measurable or evaluable disease per RECIST V1.1. Treatment group B: Presence of at least one two-dimensional measurable lesion confirmed by imaging (CT or MRI) (either lymph nodes lesions with any long diameter \> 1.5 cm or extranodal lesions with any long diameter \> 1.0 cm); for CLL patients whose baseline imaging evaluation determined that no two-dimensional measurable lesions, their peripheral blood monoclonal B lymphocytes should be ≥ 5.0×109/L. 5. Patients must provide archival tumor samples, or a 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. 6. ECOG performance status 0 or 1 7. Adequate organ function to participate in the trial. 8. Recovery from adverse events (AEs) related to prior anticancer therapy. Exclusion Criteria: 1. Prior treatment with any agent targeting ROR1. 2. History of Grade 4 immune-related adverse events (irAEs) or irAEs requiring discontinuation of prior therapies. 3. Patient with primary central nervous system (CNS) malignancy or symptomatic CNS metastases. Patients with solid tumors with CNS metastases are eligible if they do not need to receive local radiation treatment at the discretion of investigator or if radiation therapy for CNS metastases is completed ≥ 4 weeks prior to study treatment. 4. Anticancer therapy or radiation \< 5 half-lives or 4 weeks (whichever is shorter) prior to study treatment. 5. Abuse on alcohol, cannabis-derived products, or other drugs.
Where this trial is running
Frankston, Victoria and 9 other locations
- Peninsula and South Eastern Haematology and Oncology Group — Frankston, Victoria, Australia (Recruiting)
- One Clinical Research — Nedlands, Western Australia, Australia (Recruiting)
- Hunan Cancer Hospital — Changsha, Hunan, China (Recruiting)
- Affiliated Hospital of Hebei University — Baoding, China (Recruiting)
- Cancer Hospital Chinese Academy of Medical Sciences — Beijing, China (Recruiting)
- The First Affiliated Hospital of Bengbu Medical College — Bengbu, China (Recruiting)
- Zhujiang Hospital of Southern Medical University — Guangzhou, China (Recruiting)
- The Affiliated Tumour Hospital of Harbin Medical University — Harbin, China (Recruiting)
- Shandong Cancer Hospital — Shandong, China (Recruiting)
- Tianjin Medical University Cancer Institue & Hospital — Tianjin, China (Recruiting)
Study contacts
- Study coordinator: Sai Lou
- Email: slou@epimab.com
- Phone: +8613758235260
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.