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A Phase I/II Trial of EMB-02, a Bi-specific Antibody Against PD-1 and LAG-3, in Patients with Advanced Solid Tumors

Study

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Description

This is a Phase I/II trial with at least 17 patients in the dose escalation phase and 26-45 patients in the Phase II portion of the trial. In the Phase I portion of the trial, patients will receive EMB-02 at doses escalating from 6 to 900 mg IV once weekly. Following the evaluation of initial PK data, the dosing interval might be adjusted (e.g., to every 2 weeks or longer) should there be drug accumulation upon repeated dosing. Any change to dose interval due to safety concerns will involve data review by the Safety Review Committee and a protocol amendment. One treatment cycle is defined as 28 days. The doselimiting toxicity observation period is defined as 28 days.

Details
Age

Adult

Eligibility

Patients with histologically or cytologically confirmed locally advanced/metastatic solid tumors only including melanoma (excluding uveal melanoma), cutaneous squamous cell carcinoma (CSCC), non-small cell lung cancer (NSCLC), triple negative breast cancer (TNBC), mesothelioma, head and neck squamous cell carcinoma (HNSCC), nasopharyngeal cancer (NPC), hepatocellular carcinoma (HCC), gastric cancer(GC) and small cell lung cancer (SCLC), Standard therapies do not exist, are no longer effective, or are not tolerable or accessible to the patient Measurable or evaluable disease per RECIST v1.1

Phase

I - Research Studies that focus on the safety of a drug. The goal is to determine the drug's most frequent and serious adverse events and, often, how the drug is broken down and excreted by the body. These studies usually involve a small number of participants.

Type of Study

Treatment

Locations

Memorial Hospital Central
Memorial Hospital North

Principal Investigator
Robert Hoyer

Robert Hoyer

Study ID

Protocol Number: 20-2545

More information available at ClinicalTrials.gov: NCT04618393

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