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Recruiting Phase 1 NCT07229313

A Study of KIVU-107 in Participants With Locally Advanced or Metastatic Solid Tumors

Phase 1 – testing safety in a small group of people
Conditions: Advance Solid Tumors

Sponsor: Kivu Bioscience Inc.

trial.available_in: БГ
Overview
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.
Who can participate
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.
Locations 2
Australia (1)
Kivu Trial Site
Camperdown , New South Wales
United States (1)
Kivu Trial Site
Santa Monica , California
Technical details
Status
Recruiting
Phase
Phase 1
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
13.11.2025
Completion date
31.03.2030
Registry ID
NCT07229313
Source
anzctr
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