A Study of EMB-02 in Participants With Advanced Solid Tumors

NCT ID: NCT04618393

Last Updated: 2024-05-21

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 47 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-11
• Study Completion Date: 2024-03-21

Brief Summary

The primary purpose of this study is to identify the recommended Phase 2 dose(s) (RP2Ds) and schedule assessed to be safe for EMB-02 and to characterize the safety and tolerability of EMB-02 at the RP2Ds. Pharmacokinetics (PK), immunogenicity, and the anti-tumor activity of EMB-02 will also be assessed.

Detailed Description

This is a Phase I/II, multi-center, open label, multiple-dose, first in human study, designed to assess safety and tolerability, and to identify the maximum tolerated dose (MTD) and/or recommended Phase 2 dos(s)e (RP2D[s]) for EMB-02 in patients with advanced solid tumors. Pharmacokinetics, pharmacodynamics, immunogenicity, and response will also be assessed.

Conditions

Advanced Solid Tumors

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

EMB-02

In Phase I part: participants enrolled in the different time will receive EMB-02 once weekly (IV) at different ascending dose levels.

In Phase II part: participants will receive EMB-02 once weekly (IV) at previously defined RP2D.

Group Type: EXPERIMENTAL

EMB-02

Intervention Type: BIOLOGICAL

EMB-02 is a FIT-Ig® bispecific antibody against PD-1 and LAG-3.

Interventions

EMB-02

EMB-02 is a FIT-Ig® bispecific antibody against PD-1 and LAG-3.

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Willing and able to provide written informed consent.
• Phase I: Patients with histologically or cytologically confirmed locally advanced/metastatic solid tumors and have failed (progressed on, or are intolerant of) standard therapies. Moreover, the disease should be measurable or evaluable per RECIST v1.1
• Phase II Cohort A: Patients with histologically or cytologically confirmed locally advanced/metastatic melanoma, excluding uveal melanoma. > 1 prior therapy, including prior treatment with PD-1/L1(mandatory) and/or CTLA-4 inhibitors(optional). And the disease is measurable or evaluable per RECIST v1.1
• Archival tumor samples available for retrospective analysis or biopsy will be taken.
• ECOG performance status 0 or 1 for phase I, and ≤2 for phase II; life expectancy > 3 Months
• Adequate organ function to participate in the trial.
• Recovery from adverse events (AEs) related to prior anticancer therapy.
• Highly effective contraception

Exclusion Criteria

• Patients who have active autoimmune disease or history of autoimmune disease
• History of severe irAE.
• History of severe allergic reactions
• Use of systemic corticosteroids.
• Symptomatic central nervous system metastases.
• Patients with cardiac dysfunction
• Uncontrolled diabetes mellitus with hemoglobin A1c > 8% (via medical history)
• Prior treatment with a LAG-3 inhibitor
• Anticancer therapy or radiation < 5 half-lives or 4 weeks (whichever is shorter) prior to study treatment;
• Prior organ or stem cell/bone marrow transplant.
• Concurrent malignancy < 5 years prior to entry.
• Patients with active infections.
• Major surgery < 4 weeks or minor surgery < 2 weeks prior to study treatment
• Live virus vaccines < 30 days prior to screening
• Pregnant or breast-feeding females
• Any investigational agents or study drugs from a previous clinical study within 30 days of the first dose of study treatment
• Any other serious underlying medical conditions
• Abuse on alcohol, cannabis- derived products or other drugs

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai EpimAb Biotherapeutics Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Colorado Health Medical Group

Colorado Springs, Colorado, United States

Prisma Health-Upstate

Greenville, South Carolina, United States

Southern Medical Day Care Centre

Wollongong, New South Wales, Australia

Monash Health

Clayton, Victoria, Australia

Peninsula & South Eastern Haematology & Oncology Group (PASO)

Frankston, Victoria, Australia

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

The first Affiliated Hospital of Xiamen University

Xiamen, Fujian, China

HanDan Central Hospital

Handan, Hebei, China

HeNan Provincial People's Hospital

Zhengzhou, Henan, China

SuiNing Central Hospital

Suining, Sichuan, China

Countries

United States; Australia; China

References

Day D, Ganju V, Chung K, Si L, Mao L, Aghmesheh M, Hoyer R, Brewin K, Zeng S, Zhang M, Lu Q, Jiang C, Ren F, Zhu Y, Guo J. First-in-human phase I study of EMB-02, a bispecific antibody targeting PD-1 and LAG-3 in patients with advanced solid tumors. Br J Cancer. 2025 Jun;132(10):905-912. doi: 10.1038/s41416-025-02990-x. Epub 2025 Apr 15.

Reference Type: DERIVED

PMID: 40234667 (View on PubMed)

Jiang C, Ren F, Zhang M, Lu Q, Zeng S, Yang G, Zhu Y. Using Pharmacokinetic and Pharmacodynamic Analysis to Optimize the Dosing Regimens of Fanastomig (EMB-02) in Patients With Advanced Solid Tumors. CPT Pharmacometrics Syst Pharmacol. 2025 May;14(5):975-986. doi: 10.1002/psp4.70011. Epub 2025 Mar 11.

Reference Type: DERIVED

PMID: 40067130 (View on PubMed)

Other Identifiers

EMB02X101

Identifier Type: -

Identifier Source: org_study_id