First in Human Study of EMB-07 in Locally Advanced/Metastatic Solid Tumors or Relapse/Refractory Lymphoma
NCT ID: NCT05607498
Last Updated: 2025-03-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
150 participants
INTERVENTIONAL
2023-03-01
2026-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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EMB-07-Patients with solid tumor
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.
EMB07
EMB07 is a MAT-Fab bispecific antibody against CD3 and RORI
EMB07-Patients with lymphoma
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.
EMB07
EMB07 is a MAT-Fab bispecific antibody against CD3 and RORI
Interventions
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EMB07
EMB07 is a MAT-Fab bispecific antibody against CD3 and RORI
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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EpimAb Biotherapeutics (Suzhou)Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Peninsula and South Eastern Haematology and Oncology Group
Frankston, Victoria, Australia
One Clinical Research
Nedlands, Western Australia, Australia
Hunan Cancer Hospital
Changsha, Hunan, China
Affiliated Hospital of Hebei University
Baoding, , China
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, , China
The First Affiliated Hospital of Bengbu Medical College
Bengbu, , China
Zhujiang Hospital of Southern Medical University
Guangzhou, , China
The Affiliated Tumour Hospital of Harbin Medical University
Harbin, , China
Shandong Cancer Hospital
Shandong, , China
Tianjin Medical University Cancer Institue & Hospital
Tianjin, , China
Countries
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Central Contacts
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Facility Contacts
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Quchang Ouyang
Role: primary
Youchao Jia
Role: primary
Yanli Yang
Role: primary
Huan Zhou
Role: backup
Sanfang Tu
Role: primary
Qingyuan Zhang
Role: primary
Zengjun Li
Role: primary
Yuping Sun
Role: backup
Lanfang Li
Role: primary
Other Identifiers
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EMB07X101
Identifier Type: -
Identifier Source: org_study_id
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