Phase 1/2 Study of PRO1184 in Patients With Locally Advanced and/or Metastatic Solid Tumors

PRO1184 is an antibody drug conjugate that is directed to folate molecules to bind to cells with folate receptor in order to deliver the attached cytotoxic payload molecules

In this study, the sponsor and investigators want to learn:

• How much of the study agent can be given with an acceptable level of side effects
• The effects of the study agent (good and bad)
• How much of the study agent is absorbed into the blood and how fast it is removed
• If research tests can be used in the future to predict who will benefit from PRO1184
• How the study agent is acting on your body

This is a dose escalation/expansion study. Dose Escalation means that the amount of the study agent given will be increased in each group of research participants, to find the most appropriate dose for further study. The sponsor anticipates exploring 7 dose levels in the dose escalation part of the study. In the dose expansion part of the study, a larger number of people receive the study drug dose determined to be appropriate in the dose escalation part of the study. The study will be conducted in 4 main parts.

• Part A: Participants will receive the study agent by itself. Study doctors will try different doses of the study agent to see what is safe and what works best.
• Part B: Participants will receive the study agent by itself. Study doctors will give an approved dose deemed safe in Part A. If you are in Part B and have ovarian or endometrial cancer, you may receive one of two approved doses from Part A.
• Part C: Participants will receive the study agent by itself. This part is only for people who have ovarian cancer.
• Part D: Participants will receive the study agent with, Pembrolizumab, Bevacizumab or Carboplatin. If you are in Part D, the combination you receive will depend on your type of cancer.

The part and dose of the study agent you receive will be determined by when you enroll into the study and the type of cancer you have.

The study regimen will be given in cycles.  Each cycle is 21 days.  You will receive the study agent on day 1 of every cycle as an infusion into your vein (IV infusion) over 30 minutes.