A Study of MRG004A in Patients With Tissue Factor Positive Advanced or Metastatic Solid Tumors
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.
An Open-Label, Multi-center, Phase I/II Dose Escalation and Expansion Study to Assess the Safety, Tolerability, Anti-Tumor Activity and Pharmacokinetics of MRG004A in Patients With Tissue Factor Positive Advanced or Metastatic Solid Tumors
This study consists of two parts. Part A is a dose escalation study to determine the maximum tolerated dose (MTD) and recommended phase II dose (RP2D) of MRG004A. Part B is a disease specific multi-cohort dose expansion study to further assess the efficacy and safety of MRG004A at confirmed RP2D.
You can join if…
Open to people ages 18 years and up
- 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.
10. A negative serum pregnancy test if female and aged between 18-55 years old. 11. 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 CAN'T join 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.
10. Uncontrolled or poorly controlled hypertension. 11. History of ventricular tachycardia, or torsade des pointes. 12. History of moderate to severe dyspnea at rest. 13. 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.
14. 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.
15. 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.
16. Active uncontrolled bacterial, viral, fungal, rickettsial, or parasitic infection. 17. Use of systemic corticosteroids within 4 weeks prior to the first dose of treatment. 18. Use of strong CYP3A4 inhibitors or inducers with MRG004A. 19. Other excluded medications or treatment: therapeutic anti-coagulative, or long-term
anti-platelet treatment; multivitamins, calcium, vitamin D, and prophylactic anti-RANKL (denosumab) and zoledronic acid therapies for bone metastases are allowed.
20. Any patient with a positive pregnancy or is breast-feeding. 21. Any severe and/or uncontrolled systemic disease that at the discretion of investigator
and sponsor makes it undesirable for the patient to participate in this study.
- Chao Family Comprehensive Cancer Center
accepting new patients
Orange California 92868-3201 United States
- The Christ Hospital Cancer Center
accepting new patients
Cincinnati Ohio 45219 United States
- accepting new patients
- Start Date
- Completion Date
- Shanghai Miracogen Inc.
- Phase 1/2 research study
- Study Type
- Expecting 181 study participants
- Last Updated
Please contact me about this study
We will not share your information with anyone other than the team in charge of this study. Submitting your contact information does not obligate you to participate in research.
The study team should get back to you in a few business days.