Brief Summary
For solid tumors and lymphomacancers of the lymphatic system, respectively: This study is to evaluate the safety and tolerability of EMB-07 and to determine the maximum tolerated dosethe amount of medication taken (MTD) and/or recommended Phase 2 dose (RP2D). Pharmacokinetics (PK), immunogenicity, and the anti-multiple myeloma activity of EMB-07 will also be assessed.
Intervention / Treatment
- Drug: EMB07
Inclusion Criteria:
- Willing and able to provide signed and dated informed consenta process in which a patient receives detailed information about a procedure or treatment, including its potential risks, benefits, and alternatives. The patient then has the opportunity to understand the information and voluntarily agree to the procedure or treatment. 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 advancedat a late stage, far along unresectable or metastatic solid tumors limiting to triple-negative breast cancera disease where abnormal cells split without control and spread to other nearby body tissue and/or organs, lung adenocarcinomacancer arising from mucus-producing glands in organs, ovarian cancer, pancreatic cancer, colorectalrelating to the colon or rectum in the large bowel/intestine cancer, gastric cancer, prostatea walnut-shaped gland in the male reproductive system that is responsible for producing semen - a bodily fluid that acts as a vessel for sperm transport during ejaculation cancer, bladdera hollow, muscular sac in the pelvis that stores urine cancer, and uterus cancer. Treatment group B: Patients with histologically or cytologically relapsethe return of disease/refractory lymphoma limiting to chronica long-lasting disease that changes slowly over time 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 imagingtests that create detailed images of areas inside the body (CT or MRI) (either lymph nodessmall bean-shaped structures that filters harmful substances from lymph fluid 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 bloodthe red bodily fluid that transports oxygen and other nutrients around the body monoclonal B lymphocytes should be ≥ 5.0×109/L.
- Patients must provide archival tumor samples, or a biopsyremoval of a section of tissue to analyse for cancer cells will be required if archival tumor sample is not available. Archival tumor sample must be taken ≤ 2 years prior to screeningtesting for cancer or conditions that can lead to cancer before symptoms appear, also known as cancer 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.