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

A Phase 1 Dose-Finding and Dose Optimization-Expansion 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