First in Human Study of EMB-07 in Locally Advanced/Metastatic Solid Tumors or Relapse/Refractory Lymphoma
Advanced/Metastatic Solid Tumors, Relapse/Refractory Lymphoma
About this trial
This is an interventional treatment trial for Advanced/Metastatic Solid Tumors focused on measuring Phase I, Bispecific antibody, CD3, ROR1, EMB07, Dose escalation, Advanced/Metastatic Solid Tumors, Relapse/Refractory Lymphoma
Eligibility 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. Male or female, and aged ≥ 18 years 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). 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. 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. ECOG performance status 0 or 1 Adequate organ function to participate in the trial. Recovery from adverse events (AEs) related to prior anticancer therapy. Exclusion Criteria: Prior treatment with any agent targeting ROR1. History of Grade 4 immune-related adverse events (irAEs) or irAEs requiring discontinuation of prior therapies. 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. Anticancer therapy or radiation < 5 half-lives or 4 weeks (whichever is shorter) prior to study treatment. Abuse on alcohol, cannabis-derived products, or other drugs.
Sites / Locations
- Peninsula and South Eastern Haematology and Oncology GroupRecruiting
- One Clinical ResearchRecruiting
- Hunan Cancer HospitalRecruiting
- Affiliated Hospital of Hebei UniversityRecruiting
- Cancer Hospital Chinese Academy of Medical SciencesRecruiting
- The First Affiliated Hospital of Bengbu Medical CollegeRecruiting
- Zhujiang Hospital of Southern Medical UniversityRecruiting
- The Affiliated Tumour Hospital of Harbin Medical UniversityRecruiting
- Shandong Cancer HospitalRecruiting
- Tianjin Medical University Cancer Institue & HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
EMB-07-Patients with solid tumor
EMB07-Patients with lymphoma
Patients with solid tumor will receive intravenous infusions of EMB-07 weekly (QW). Dose escalation will continue until the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) is reached or all planned doses are administered.
Patients with lymphoma will receive intravenous infusions of EMB-07 weekly (QW). Dose escalation will continue until the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) is reached or all planned doses are administered.