Full Title
A Phase 1, Open Label, Dose-Escalation and Expansion Study to Evaluate the Safety, Pharmacokinetics and Initial Therapeutic Activity of AVA6000, a Novel FAP-activated Doxorubicin Administered Intravenously in Patients with Locally Advanced or Metastatic Selected Solid TumoursPurpose
The purpose of this study is to find the highest dose of the investigational drug AVA6000 that can be given safely in people with advanced solid tumors that are not responding to treatment. AVA6000 is very similar to a standard chemotherapy drug called doxorubicin. Like doxorubicin, AVA6000 works to slow or stop the growth of cancer cells by blocking an enzyme. Unlike doxorubicin, however, AVA6000 is a “prodrug,” meaning it remains inactive until it reaches the site of the cancer. Because of the way AVA6000 works, it may be useful for treating cancer with fewer side effects than doxorubicin. AVA6000 is given intravenously (by vein).
Who Can Join
To be eligible for this study, patients must meet several requirements, including:
- Participants must have inoperable or metastatic pancreatic, colorectal, non-small cell lung, head and neck, ovarian, breast, bladder, esophageal, prostate, or biliary tract cancer, soft tissue sarcoma, or cancer of unknown primary that continues to grow despite standard treatment.
- At least 4 weeks must pass between the completion of prior therapies and receipt of AVA6000.
- Patients must be physically well enough that they are able to be mobile, take care of themselves, and engage in all but physically strenuous activities. For example, they must be well enough that they could carry out office work or light housework.
- This study is for people age 18 and older.
Contact
For more information and to ask about eligibility for this study, please contact the office of Dr. William Tap at 646-888-4163.