Testing EMB-01 for advanced solid tumors

First-in-human, Phase I/II, Multicenter, Open-Label Study of EMB-01 in Patients With Advanced/Metastatic Solid Tumors

This study is testing a new treatment called EMB-01 for people with advanced solid tumors to see how well it works and if it's safe.

Quick facts

• Phase: PHASE1; PHASE2
• Study type: Interventional
• Enrollment: 186 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Shanghai EpimAb Biotherapeutics Co., Ltd. (industry)
• Drugs / interventions: osimertinib, radiation
• Locations: 5 sites (Boston, Massachusetts and 4 other locations)
• Trial ID: NCT03797391 on ClinicalTrials.gov

What this trial studies

This is a first-in-human, open-label study evaluating EMB-01, a bispecific antibody targeting EGFR and c-Met, in patients with advanced or metastatic solid tumors. The study is divided into two phases: Phase I focuses on dose escalation, while Phase II involves cohort expansion based on molecular status. Participants will be screened for specific genetic aberrations and will receive treatment cycles lasting up to two years, with safety follow-ups after the last dose.

Who should consider this trial

Good fit: Ideal candidates include patients with advanced/metastatic solid tumors, particularly those with EGFR mutations or c-Met aberrations who have progressed on standard therapies.

Not a fit: Patients with early-stage tumors or those who have not yet received standard treatments may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors that have limited or no standard treatment options.

How similar studies have performed: Other studies targeting similar pathways have shown promise, indicating potential for success in this novel approach.

Eligibility criteria

Inclusion Criteria:

Molecular Pre-screening Inclusion criteria (Phase II only)

1. The patient must sign the molecular pre-screening Inform Consent to allow for the molecular pre-screening process. All patients must have documented evidence of EGFR and/or cMet aberrations.

Screening Inclusion Criteria

1. Able to understand and willing to sign the Informed Consent Form (ICF).
2. Histologically/cytologically confirmed advanced/metastatic solid tumors with measurable disease \[Response Evaluation Criteria in Solid Tumors (RECIST) v1.1\]:

   Phase I: advanced/metastatic solid tumors including but not limited to NSCLC, colorectal cancer, gastric cancer and liver cancer refractory to standard therapy or for which no standard therapy is available or accessible.

   Phase II: Advanced/metastatic NSCLC Patients have confirmed EGFR mutant and/or cMET aberration, and have progressed after standard treatment (including platinum-based therapy) or are intolerant to standard treatment. Additionally, patients with T790M mutation have received FDA/Health Authority approved therapies (if accessible) for this indication (i.e., osimertinib) and have progressed or became intolerant.

   A patient who has refused all currently available therapy is allowed to enroll, but must be documented in the source record.
3. Must have adequate organ function.
4. Regarding prior anti-tumor therapy:

   1. Must have stopped treatment at least 4 weeks or within 5 half-lives.
   2. Generalized radiation therapy must have stopped 3 weeks before first dose of EMB 01, or local radiotherapy or radiation therapy for bone metastases must have stopped 2 weeks before first dose of EMB-01. No therapeutic radiopharmaceuticals are taken within 8 weeks before first dose of EMB-01.
   3. Patients must have recovered to ≤Grade 1 from the adverse effects of such above treatment before beginning study treatment.
5. Female patient with fertility or male patient whose partner has fertility should use one or more contraceptive methods for contraception starting from screening period and continue throughout the study treatment and for 3 months.
6. ECOG score 0 or 1 for phase I, and ≤2 for phase II.

Exclusion Criteria:

Molecular Pre-screening Exclusion Criteria (Phase II only)

Subject who meets any of the follow criteria can't be proceeded to clinical screening:

1. Patients who are unwilling to sign the molecular pre-screening ICF.
2. Patients for whom local EGFR and/or cMET data or the results of central laboratory testing do not meet the molecular pre-screening inclusion criteria.

Screening Exclusion Criteria

1. Life expectancy \< 3 months.
2. Subject with primacy central nervous system (CNS) malignancy or symptomatic CNS (leptomeningeal or brain) metastases.
3. Pregnant or nursing females.
4. Subjects who have had major surgery within 28 days prior to screening.
5. Serious underlying medical conditions, including but not limited to un-controlled hypertension, other cardiovascular disease or diabetes, ongoing or active infection, psychiatric, psychological, familial or geographical condition that, in the judgment of the investigator, may interfere the compliance with study treatment.

Where this trial is running

Boston, Massachusetts and 4 other locations

• Dana-Farber Cancer Institute — Boston, Massachusetts, United States (RECRUITING)
• Barbara Ann Karmanos Cancer Institute — Detroit, Michigan, United States (RECRUITING)
• Gabrail Cancer Center Research — Canton, Ohio, United States (RECRUITING)
• Guangdong General Hospital — Guangzhou, Guang Dong, China (RECRUITING)
• Shanghai Chest Hosptial — Shanghai, Shanghai, China (RECRUITING)

Study contacts

• Study coordinator: Xiaodong Sun, MD

Conditions: Neoplasms, Neoplasm Metastasis, Non-Small-Cell Lung Cancer, Human Bispecific antibody,, Epidermal Growth Factor Receptor,, c-Mesenchymal-Epithelial Transition,, Neoplasms, Neoplasm Metastasis,, Non-Small-Cell Lung Cancer, First-in-human,