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
DISEASE: SOLID TUMORS
This Clinical Study is to test a new drug called MRG004A. This is what is a “first in human testing” study. The study will test different doses of the drug to determine the best dose as well as what the side effects are and how well it works on cancer.
MRG004A is an antibody-drug conjugate (a conjugate is comprised of two or more different drugs combined into one drug) that specifically binds to a growth-promoting protein known as Tissue Factor (TF). Many types of tumors have increased levels of TF on their cells, called TF positive cancer. MRG004A travels through the blood and binds to the TF surface receptors on tumor cells and then is taken into the tumor cell where it kills the cell. Since tumors have increased levels of TF the drug is taken into the cancer cells at a much higher amount than what is taken up by normal cells. This potentially decreases the side effects experienced by this drug.
The study consists of two parts: Phase I (Part A) and Phase II (Part B).
Part A: Includes dose escalation that focuses on determining the safest dose to give that works best on the cancer. Patients will go through several dose levels with the safest dose determined by what side effects are experienced. This optimal dose is then used in Part B.
Part B: Will use the optimal dose determined in Part A to study the effects on cancer. While Part A of the study includes people without TF expression, Part B will focus on 5 cancers known to express TF; including pancreatic, cervical, platinum-resistant ovarian cancer, advanced non-small cell lung cancer, and other cancer types.
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