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

RecruitingPhase 1

A Phase 1 Dose-Finding and Dose-Expansion Study of KIVU-107 in Participants With Locally Advanced or Metastatic Solid Tumors

Who can join

Ages 18 and older · All sexes

Full eligibility criteria

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.

About the study

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.

What is being tested

KIVU-107 (drug)

Sponsor: Kivu Bioscience Inc. · Participants: 76 · Started: Nov 13, 2025

Contact the study team

Kivu Bioscience (US) · Phone: +1.650.606.5170
Kivu Bioscience (Australia) · Phone: +61 8 7223 0122

Official record on ClinicalTrials.gov — NCT07229313

Locations in the U.S.

California	Kivu Trial Site, Santa Monica
Connecticut	Kivu Trial Site, New Have

Conditions

From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.