A Study of KIVU-305 in Participants With Locally Advanced or Metastatic Solid Tumors

This is a 2-part, first-in-human, open-label study to determine the safety, tolerability and preliminary efficacy of KIVU-305, a CEACAM5-directed antibody-drug conjugate, in participants with locally advanced or metastatic solid tumors.

Inclusion Criteria: * Male or female ≥18 years of age * 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 a topoisomerase 1 inhibitor payload * Prior treatment with any CEACAM5 targeted therapy * Uncontrolled cardiovascular disease * Uncontrolled 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