A Phase 1, Open-Label, Dose Escalation and Expansion Study of TH1902 in Patients with Advanced Solid Tumors

TH1902 is docetaxel with a targeting peptide that interacts with Sortilin, a membrane protein overexpressed by many tumors.

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

• How much of the study drug can be given with an acceptable level of side effects
• The effects of the study drug (good and bad)
• How much of the study drug 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 TH1902

The length of your individual participation will be about 12 months if you are tolerating the study procedures, and your cancer is stable or improving. The study will be divided into “treatment cycles” of 28 days each in which you will receive the study drug 3 weeks in a row followed by 1 week of pause. The number of cycles you receive will depend on how well you tolerate the study drug and your overall condition.

If you are eligible and agree to participate in the study, you will be randomly (by chance, like the flip of a coin) assigned to one of the doses. You will need to come to the study center for each of your doses of study drug.

You will receive the study drug as an intravenous infusion (slow injection into your veins). Your infusion will take approximately 30 minutes and will be given on Days 1, 8 and 15 of every 28-day cycle (i.e., 3 weeks in row followed by 1 week of pause; 3/1 dosing regimen).