This is a 2-part, first-in-human, open-label study to determine the safety and tolerability of KIVU-107, a PTK7-directed antibody-drug conjugate, in participants with locally advanced or metastatic solid tumors.

Part A: The primary objective of Part A of this study is to evaluate the safety and tolerability of KIVU-107 and to determine the maximum tolerated dose (MTD)/Recommended Dose for Expansion (RDE).

Part B: The primary objective of Part B of this study is to confirm the safety and tolerability of KIVU-107 at the RDE.

Inclusion Criteria:

• Male or female ≥18 years of age
• No therapy of proven efficacy exists for the tumor
• Pathologically or histologically documented diagnosis of advanced / metastatic solid tumor malignancy that is resistant to standard therapy or for which no standard therapy is available.
• Adequate bone marrow, kidney, and liver function
• Measurable disease using RECIST v1.1
• ECOG 0 or 1
• Life expectancy ≥ 3 months

Exclusion Criteria:

• Prior treatment with any ADC with topoisomerase 1 inhibitor payload
• Any PTK7 - targeted therapy
• Uncontrolled cardiovascular disease
• Active Hepatitis B, Hepatitis C, or HIV infection
• History of interstitial lung disease
• Major surgery, radiation therapy, or systemic anti-cancer within 3 weeks of study treatment start.

We are committed to enhancing public health through responsible sharing of clinical trial data. Following approval of a new product or a new indication for an approved product, the study sponsor and/or its affiliated companies will share study protocols, anonymized patient data and study level data, and redacted clinical study reports with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research.