A Study to Evaluate the Efficacy and Safety of MRG003 in Patients With Recurrent Metastatic Nasopharyngeal Carcinoma

• Status: Recruiting
• Trial end date: 2023-10-15
• Target enrollment: 0
• Participant gender: All

Summary

The objective of this study is to assess the safety, efficacy, pharmacokinetics, and immunogenicity of MRG003 in patients with recurrent metastatic nasopharyngeal carcinoma.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai Miracogen Inc.

Criteria

Inclusion Criteria:

• Willing to sign the ICF and follow the requirements specified in the protocol.

• Age: ≥18 years, both genders.

• Expected survival time>3 months.

• Patients with histologically confirmed unresectable, radiation-ineligible recurrent metastatic nasopharyngeal carcinoma.

• Part A: Metastatic nasopharyngeal carcinoma that has failed or recurred or was intolerant to at least two lines of prior systemic therapy with platinum-based regimens.

• Part B: Cohort 1: Metastatic nasopharyngeal carcinoma that has failed or recurred or was intolerant to prior systemic therapy with a first-line platinum-based regimen. Cohort 2: Metastatic nasopharyngeal carcinoma that has failed or relapsed after or is intolerant to at least two prior lines of platinum-based systemic therapy.

• Patients must have measurable lesions according to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1).

• ECOG performance score 0 or 1.

• Organ functions and coagulation function must meet the basic requirements.

• No severe cardiac dysfunction with left ventricular ejection fraction (LVEF) ≥ 50%.

• Serum or urine pregnancy test negative within 72 hours before the first dose of investigational drug.

• Patients with childbearing potential must use effective contraception during the treatment and for 6 months after the last dose of treatment.

Exclusion Criteria:

• Part A: received < 2 prior lines of systemic therapy.

• Part B: Cohort 1 received two lines of prior therapies; Cohort 2 received the first line of prior therapy only.

• History of 4 or more systemic anti-tumor therapies for the recurrent metastatic nasopharyngeal carcinoma.

• Expected surgery or any other form of systemic or local anti-tumor therapy.

• History of systemic chemotherapy, antitumor biological therapy or immunotherapy, or major surgery within 3 weeks, >30 Gy thoracic radiotherapy within 6 months, prior radiotherapy within 14 days before the first administration of the investigational drug.

• Known active CNS metastasis and/or cancerous meningitis.

• Residual toxicity reactions caused by previous anti-tumor treatment or abnormal values of laboratory tests higher than grade 1 (CTCAE v5.0).

• Uncontrolled or poorly controlled heart disease.

• History of pulmonary embolism or deep vein thrombosis within 3 months before the first administration of the investigational drug.

• Known history of malignancy.

• Uncontrolled or poorly controlled hypertension.

• Patients with a history of active bleeding, coagulopathy, or receiving coumarin anticoagulation therapy.

• Subjects with a history of ≥ Grade 3 immune-related AEs (irAEs).

• Known allergic reaction to any ingredients or excipients of MRG003.

• Known active hepatitis B or C.

• Complicated with severe, uncontrolled infection or known human immunodeficiency virus (HIV) infection, or diagnosed as acquired immunodeficiency syndrome (AIDS); or uncontrolled autoimmune disease; or history of allogeneic tissue/organ transplantation, stem cell or bone marrow transplantation, or solid organ transplantation.

• Active bacterial, viral, fungal, rickettsia, or parasitic infections that require systemic anti-infective treatment.

• Vaccination of live virus vaccine within 30 days before the first administration of the study drug. Inactivated seasonal influenza vaccine or approved COVID-19 vaccine is allowed.

• Moderate to severe dyspnea at rest caused by advanced cancer or its complications, or severe primary lung disease, oxygen saturation < 93% in non-oxygen state, or history of any interstitial lung disease or interstitial lung disease (ILD) requiring oral or intravenous glucocorticoids or non-infectious pneumonia.

• Patients receiving immunology-based treatment for any reason.

• Chronic autoimmune disease or inflammatory disease requiring systemic therapy or receiving systemic therapy within the past 2 years.

• Uncontrolled pleural effusion, pericardial effusion or recurrent ascites.

• Potent CYP3A4 inhibitors or inducers are in use and cannot be discontinued.

• Women who are lactating or pregnant.

• Other conditions that in the clinical judgement of the investigator make the patient not suitable for participation in this study.