A Study of MRG003 in Patients With Advanced Solid Tumors

• Status: Completed
• Trial end date: 2021-03-29
• Target enrollment: 0
• Participant gender: All

Summary

The objective of this study is to assess the safety, efficacy, and pharmacokinetics of MRG003, as well as immunogenicity as defined by the incidence of anti-drug antibody (ADA) of MRG003 in patients with advanced solid tumors, including colorectal cancer, squamous cell carcinoma of head and neck, and nasopharyngeal carcinoma.

• Phase: Phase 1
• 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 and ≤75 years, both genders

• Expected survival time≥12 weeks

• Phase Ia: Patients with histologically and cytologically confirmed advanced or metastatic solid tumor

• Phase Ib: Patients with histologically and cytologically confirmed EGFR-positive advanced or metastatic colorectal cancer, squamous cell carcinoma of head and neck, and nasopharyngeal carcinoma

• Subjects must have measurable lesions according to the response Evaluation Criteria In Solid Tumors（RECIST v1.1）

• ECOG performance score 0 or 1

• Acceptable liver, renal, and hematologic function

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

Exclusion Criteria:

• History of hypersensitivity to any component of the investigational product

• Presence of central nervous system metastasis

• Prior history of other primary malignancies

• Known history of clinically significant hepatic diseases

• Evidence of active infection of human immunodeficiency virus (HIV)

• History of ophthalmic abnormalities

• Any severe or uncontrolled systemic disease judged by the investigator

• Patients with poorly controlled heart diseases

• Received radiotherapy, chemotherapy, biotherapy, immunotherapy or other anti-tumor drugs within 4 weeks prior to the first dose of study treatment

• Major surgery or surgical therapy for any cause within 4 weeks prior to the first dose of investigational drug

• Planned surgery or surgery is the best interest of patients as determined by investigator

• History of severe skin disease requiring interruption of previous EGFR targeted therapy; or chronic skin disease requiring oral or intravenous therapy

• Active concomitant diseases that might increase risks of toxicity

• Pregnancy, or breast feeding