A Study of MRG003 in Patients With Advanced Solid Tumors
NCT ID: NCT04868344
Last Updated: 2021-04-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
61 participants
INTERVENTIONAL
2018-05-09
2021-03-29
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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MRG003
Phase Ia: MRG003 will be administrated by an IV infusion of escalating doses (0.1, 0.3, 0.6, 1.0, 2.0, 2.5, 3.0 mg/kg) on Day 1 of every 3 weeks (Q3W); Phase Ib: MRG003 will be administrated by an IV infusion of MTD/RP2D.
MRG003
Administered intravenously
Interventions
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MRG003
Administered intravenously
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Shanghai Miracogen Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Ruihua Xu, M.D.
Role: PRINCIPAL_INVESTIGATOR
Sun Yat-sen University
Locations
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Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Countries
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References
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Qiu MZ, Zhang Y, Guo Y, Guo W, Nian W, Liao W, Xu Z, Zhang W, Zhao HY, Wei X, Xue L, Tang W, Wu Y, Ren G, Wang L, Xi J, Jin Y, Li H, Hu C, Xu RH. Evaluation of Safety of Treatment With Anti-Epidermal Growth Factor Receptor Antibody Drug Conjugate MRG003 in Patients With Advanced Solid Tumors: A Phase 1 Nonrandomized Clinical Trial. JAMA Oncol. 2022 Jul 1;8(7):1042-1046. doi: 10.1001/jamaoncol.2022.0503.
Other Identifiers
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MRG003-001
Identifier Type: -
Identifier Source: org_study_id