First in Human Study of EMB-07 in Locally Advanced/Metastatic Solid Tumors or Relapse/Refractory Lymphoma

NCT05607498 | Recruiting Phase 1

• 1 other identifier: EMB07X101
• Study Type: interventional
• Target: 150
• Locations: 2 countries
• Sites: 10

Brief Summary

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.

Conditions

Advanced/Metastatic Solid Tumors; Relapse/Refractory Lymphoma

Keywords

Phase I; Bispecific antibody; CD3; ROR1; EMB07; Dose escalation; Advanced/Metastatic Solid Tumors; Relapse/Refractory Lymphoma

Outcome Measures

Primary Outcomes (5)

• Incidence and severity of adverse events as assessed by CTCAE V5.0.

  Incidence and severity of AE.

  Screening up to 30 days after the last dose.

• Incidence of serious adverse events (SAE).

  Incidence of SAE.

  Screening up to 30 days after the last dose, or beyond 30 days if SAE is confirmed to be treatment related.

• Incidence of dose interruptions.

  Incidence of dose interruptions of EMB-07 during treatment as a measure of tolerability.

  Screening up to 30 days after the last dose.

• Dose intensity.

  Actual amount of drug taken by patients divided by the planned amount.

  Screening up to 30 days after the last dose.

• The incidence of DLTs during the first cycle of treatment.

  The dose limiting toxicities are based on drug related adverse events and are specifically defined in study protocol.

  First infusion to the end of cycle 1. (each cycle is 28 days).

Secondary Outcomes (10)

• Overall response rate.

  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.

• Area under the serum concentration-time curve (AUC) of EMB-07.

  Through treatment until EOT visit, expected average 6 months.

• Maximum serum concentration (Cmax) of EMB-07.

  Through treatment until EOT visit, expected average 6 months.

• Trough concentration (Ctrough) of EMB-07.

  Through treatment until EOT visit, expected average 6 months.

• Average concentration over a dosing interval (Css, avg) of EMB-07.

  Through treatment until EOT visit, expected average 6 months.

Study Arms (2)

EMB-07-Patients with solid tumor

EXPERIMENTAL

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.

Drug: EMB07

EMB07-Patients with lymphoma

EXPERIMENTAL

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.

Drug: EMB07

Interventions

EMB07 DRUG

EMB07 is a MAT-Fab bispecific antibody against CD3 and RORI

EMB-07-Patients with solid tumor; EMB07-Patients with lymphoma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• EpimAb Biotherapeutics (Suzhou)Co., Ltd.: lead

Study Sites (10)

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

MeSH Terms

Conditions

Recurrence; Lymphoma

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Central Study Contacts

Sai Lou

CONTACT

+8613758235260; slou@epimab.com

Junqiang He

CONTACT

+8618302157016; jqhe@epimab.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2022
• First Posted: November 7, 2022
• Study Start: March 1, 2023
• Primary Completion: October 31, 2025
• Study Completion: March 31, 2026
• Last Updated: March 3, 2025

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

AU (2); CN (8)