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.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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.
Clareo Health | A Study of KIVU-107 in Participants With Locally Advanced or Metastatic Solid Tumors
