First in Human Study of EMB-07 in Locally Advanced/Metastatic Solid Tumors or Relapse/Refractory Lymphoma
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorEpimAb Biotherapeutics (Suzhou)Co., Ltd.
About this trial
For solid tumors and lymphoma, respectively: This study is to evaluate the safety and tolerability of EMB-07 and to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D). Pharmacokinetics (PK), immunogenicity, and the anti-multiple myeloma activity of EMB-07 will also be assessed.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
EMB07
DrugEMB07 is a MAT-Fab bispecific antibody against CD3 and RORI
Treatment groups
150 Participants
are divided into 2 treatment groupsGroup A: EMB-07-Patients with solid tumorExperimental treatment 1 intervention
Group B: EMB07-Patients with lymphomaExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Incidence and severity of adverse events as assessed by CTCAE V5.0.
Incidence and severity of AE.
Time frame
Screening up to 30 days after the last dose.2
Incidence of serious adverse events (SAE).
Incidence of SAE.
Time frame
Screening up to 30 days after the last dose, or beyond 30 days if SAE is confirmed to be treatment related.3
Incidence of dose interruptions.
Incidence of dose interruptions of EMB-07 during treatment as a measure of tolerability.
Time frame
Screening up to 30 days after the last dose.4
Dose intensity.
Actual amount of drug taken by patients divided by the planned amount.
Time frame
Screening up to 30 days after the last dose.Secondary outcomes
1
Overall response rate.
Overall response rate measured by RECIST V1.1, iWCLL-2018, Lugano 2014
Time frame
From the date of dosing untill the date of first documented progression or date of death from any casue, whichever case first, expected average 6 months.2
Area under the serum concentration-time curve (AUC) of EMB-07.
Blood samples for serum PK analysis will be obtained (AUC).
Time frame
Through treatment until EOT visit, expected average 6 months.3
Maximum serum concentration (Cmax) of EMB-07.
Blood samples for serum PK analysis will be obtained (Cmax).
Time frame
Through treatment until EOT visit, expected average 6 months.4
Trough concentration (Ctrough) of EMB-07.
Blood samples for serum PK analysis will be obtained (Ctrough).
Time frame
Through treatment until EOT visit, expected average 6 months.Sponsors and contacts
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Source ClinicalTrials.gov