A Study of MRG003 in Patients With Advanced Solid Tumors

NCT04868344 | Completed Phase 1

• 1 other identifier: MRG003-001
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Advanced Solid Tumors

Keywords

MRG003; Antibody Drug Conjugate (ADC); Solid tumors

Outcome Measures

Primary Outcomes (2)

• Dose Limiting Toxicity (DLT) - Phase Ia

  DLT is assessed on Day 21 (Day 1 to 21) of the first dose administration.

  First cycle (21 days)

• Objective Response Rate (ORR) - Phase Ib

  ORR was defined as the proportions of subjects with a complete response (CR) and partial response (PR). ORR will be assessed by investigator according to RECIST v1.1.

  Baseline to study completion (up to 24 weeks)

Secondary Outcomes (11)

• PK parameter for MRG003: Maximum Drug Concentration (Cmax)

  Baseline to study completion (up to 24 weeks)

• PK parameter for MRG003: Area Under the Curve Up to the Last Validated Measurable Plasma Concentration (AUClast)

  Baseline to study completion (up to 24 weeks)

• PK parameter for total antibody (TAb): Cmax

  Baseline to study completion (up to 24 weeks)

• PK parameter for TAb: AUClast

  Baseline to study completion (up to 24 weeks)

• PK parameter for Monomethyl Auristatin E (MMAE): Cmax

  Baseline to study completion (up to 24 weeks)

Study Arms (1)

MRG003

EXPERIMENTAL

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.

Drug: MRG003

Interventions

MRG003 DRUG

Administered intravenously

MRG003

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Miracogen Inc.: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location

Related Publications (1)

• 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.

  PMID: 35511148 DERIVED

Study Officials

• Ruihua Xu, M.D.

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2021
• First Posted: April 30, 2021
• Study Start: May 9, 2018
• Primary Completion: March 29, 2021
• Study Completion: March 29, 2021
• Last Updated: April 30, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)