A Phase 1 Dose-Finding and Dose-Expansion Study of KIVU-107 in Participants With Locally Advanced or Metastatic Solid Tumors
Kivu Bioscience Inc.
Summary
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.
Description
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 H…
Interventions
- DrugKIVU-107
KIVU-107 will be administered IV.
Locations (6)
- Kivu Trial SiteSanta Monica, California
- Kivu Trial SiteCamperdown, New South Wales
- Kivu Trial SiteSydney, New South Wales
- Kivu Trial SiteBrisbane, Queensland
- Kivu Trial SiteAdelaide, South Australia
- Kivu Trial SiteGeelong, Victoria