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NCT07229313PHASE1Recruiting

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

Kivu Bioscience Inc.

Start Date

11/13/2025

Completion Date

3/31/2030

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.

Detailed 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 Criteria

Age Range: 18 years to No maximum

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.

Interventions

DRUG

KIVU-107

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Conditions

Advance Solid Tumors

Locations

Kivu Trial Site

Santa Monica, California 90403

United States

Kivu Trial Site

Camperdown, New South Wales 2050

Australia

Kivu Trial Site

Sydney, New South Wales

Australia

Kivu Trial Site

Brisbane, Queensland

Australia

Kivu Trial Site

Adelaide, South Australia

Australia

Kivu Trial Site

Geelong, Victoria

Australia