A Phase 1 Dose-Escalation and Expansion Study Evaluating the Safety, Efficacy, and Pharmacokinetics of EVOLVE104 in Subjects with Advanced Urothelial and Squamous Cell Carcinomas

The purpose of this study is to learn about the safety of the study drug, EVOLVE104, to find out if it is effective against several different kinds of cancer, and to find the best dose for treating those kinds of cancer. Some of the tumors that EVOLVE104 might work against include some cancers of the bladder, lungs, esophagus, skin, cervix, anus and genitals. EVOLVE104 is a type of immunotherapy. Immunotherapy is a type of cancer treatment that utilizes the body's own immune system to combat cancer cells. EVOLVE104 sticks to a specific type of immune cell (called T cells) and to several proteins (antigens) found on tumor cells, which may allow the T cell to attack and kill the cancer cell. EVOLVE104 is an “investigational” drug in this study because it has not been approved by the United States Food and Drug Administration (FDA), the health authority that gives approval for new medicines in the United States. This type of drug is sometimes referred to as a “T cell engager,” some of which have been approved by the FDA to treat different types of cancer.

Are you Eligible? (Inclusion Criteria)

• Age ≥18 years at the time of signing informed consent. 2. Understands and voluntarily provides written informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. 3. Able to provide a fresh tumor biopsy, if medically feasible and would not create undue risk for the subject, or an archival tissue sample, preferably obtained within 6 months of study enrollment or since the most recent progression.