A Study of MRG004A in Patients With Tissue Factor Positive Advanced or Metastatic Solid Tumors

NCT04843709 | Completed Phase 1 FDA Drug

• 1 other identifier: MRG004A-001
• Study Type: interventional
• Target: 39
• Locations: 2 countries
• Sites: 9

Brief Summary

The objective of this study is to evaluate the safety, efficacy, pharmacokinetics, and immunogenicity of MRG004A in patients with Tissue Factor positive advanced or metastatic solid tumors.

Conditions

Advanced or Metastatic Solid Tumors

Keywords

MRG004A; Antibody drug conjugate (ADC); Tissue factor; Solid tumors

Outcome Measures

Primary Outcomes (4)

• Maximum Tolerated Dose (MTD)

  The highest dose confirmed wherein less than 2 out of 6, or \< 33% of evaluable patients in a treatment cohort experiences dose-limiting toxicity (DLT).

  DLT will be evaluated during the first treatment cycle (Day 1-21)

• Recommended Phase II Dose (RP2D)

  The dose level of MRG004A recommended for further clinical studies based on assessment of the safety, efficacy and PK data from Part A of this study.

  Baseline to study completion (up to 24 months)

• Objective Response Rate (ORR)

  The proportion of patients who achieve complete response (CR) or partial response (PR) as assessed by the Independent Central Review (ICR).

  Baseline to study completion (up to 24 months)

• Adverse Events (AEs)

  Any reaction, side effect, or untoward event that occurs during the course of the clinical trial whether or not the event is considered related to the study drug.

  From signing informed consent until 45 days after the last dose of MRG004A

Secondary Outcomes (8)

• Duration of Response (DoR)

  Baseline to study completion (up to 24 months)

• Disease Control Rate (DCR)

  Baseline to study completion (up to 24 months)

• Progression Free Survival (PFS)

  Baseline to study completion (up to 24 months)

• Overall Survive (OS)

  Baseline to study completion (up to 24 months)

• Pharmacokinetics (PK) Parameter of MRG004A: Cmax

  Baseline to 30 days after the last dose of study treatment

Study Arms (1)

MRG004A

EXPERIMENTAL

All patients in Part A (dose escalation) and Part B (dose expansion) will be administrated MRG004A on Day 1 of every 3 weeks (21-day cycle).

Drug: MRG004A

Interventions

MRG004A DRUG

Administrated intravenously

MRG004A

Eligibility Criteria

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

You may qualify if:

• Understands and provides written informed consent and willing to follow the requirements specified in protocol.
• Age ≥18 years.
• Life expectancy ≥6 months.
• For Part B patients, documented Tissue Factor (TF) presence in tumor biopsy specimens obtained from archival or re-biopsy specimens by immunohistochemistry (IHC) protein expression.
• Must have histologically or cytologically confirmed unresectable or metastatic cancer with documented disease progression during prior therapy, or relapse or progression following approved standard therapy for their tumor types- Part A and Part B.
• Part B: Patients who have documented progression during or relapse following standard therapy, no further treatment options that are known to improve survival, and participation in a clinical trial is a reasonable therapeutic option.
• Patients must have measurable disease per RECIST v1.1.
• ECOG performance status of 0 or 1.
• Acceptable bone marrow, hepatic, cardiac, renal, and coagulation function.
• A negative serum pregnancy test if female and aged between 18-55 years old.
• Patients, both females and males, of reproductive potential must agree to use adequate contraception during and for 180 days after the last infusion of MRG004A.

You may not qualify if:

• Archival or biopsy tumor shows TF IHC membrane or cytosolic score of zero, no TF-positive expression or no TF-positive staining in Part B patients.
• Toxicities (except alopecia \& fatigue) due to prior antitumor therapy are greater than CTCAE v5.0 Grade 1.
• Toxicities due to prior radiotherapy that have not resolved to Grade ≤ 1 CTCAE v5.0 at least 21 days prior to the first treatment.
• Untreated, unstable or uncontrolled central nervous system (CNS) metastases.
• Any other type of anti-cancer therapy within 21 days of the first dose of study treatment. Use of any other type of anti-cancer treatment is prohibited throughout the study.
• Patients with increased bleeding risk.
• Presence of severe cardiac dysfunction.
• Pulmonary embolism or deep vein thrombosis within 3 months prior to the first dose of study drug.
• Concurrent malignancy within 5 years prior to entry.
• Uncontrolled or poorly controlled hypertension.
• History of ventricular tachycardia, or torsade des pointes.
• History of moderate to severe dyspnea at rest.
• Major surgery within 4 weeks of the first dose of study treatment and not fully recovered. Minor surgery within 2 weeks prior to study treatment.
• Known allergic reactions to any component or excipient of MRG004A or known allergic reactions to other prior anti-TF (including investigational) or other monoclonal antibody ≥ Grade 3.
• Patients who have any known liver disease, including chronic hepatitis B, hepatitis C, autoimmune hepatic disorders, primary biliary cirrhosis or sclerosing cholangitis; Patients who have concurrent, serious, uncontrolled infections or known infection with HIV, or have a diagnosed acquired immunodeficiency syndrome (AIDS); or an uncontrolled autoimmune disease, or have undergone organ transplant.

Sponsors & Collaborators

• Lepu Biopharma Co., Ltd.: lead

Study Sites (9)

Chao Family Comprehensive Cancer Center

Orange, California, 92868-3201, United States

Location

Memorial Sloan Kettering 60th Street Outpatient Center

New York, New York, 10065, United States

Location

Gabrail Cancer Center Research

Canton, Ohio, 44718, United States

Location

The Christ Hospital Cancer Center

Cincinnati, Ohio, 45219, United States

Location

Gettysburg Cancer Center

Gettysburg, Pennsylvania, 17325, United States

Location

Virginia Cancer Specialists

Fairfax, Virginia, 22031, United States

Location

Hunan Cancer Hospital

Changsha, Hunan, 410013, China

Location

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 201321, China

Location

The First Affiliated Hospital, College of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310003, China

Location

Study Officials

• Nashat Y Gabrail, MD

  Gabrail Cancer Center Research

  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 8, 2021
• First Posted: April 13, 2021
• Study Start: July 26, 2021
• Primary Completion: March 20, 2024
• Study Completion: July 26, 2024
• Last Updated: May 15, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3); US (6)