RecruitingPhase 1NCT07229313

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

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


Sponsor

Kivu Bioscience Inc.

Enrollment

76 participants

Start Date

Nov 13, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new drug called KIVU-107 — a type of antibody-drug conjugate (a targeted therapy that delivers a cell-killing payload directly to cancer cells) — in people with advanced or metastatic solid tumors that have not responded to standard treatments. **You may be eligible if...** - You are 18 or older with a confirmed advanced or metastatic solid tumor - Your cancer is resistant to standard therapy or no standard therapy is available - You have adequate bone marrow, kidney, and liver function - You have measurable disease on scans (per RECIST criteria) - Your general health is good (ECOG 0 or 1) and life expectancy is at least 3 months **You may NOT be eligible if...** - You have previously received any antibody-drug conjugate with a topoisomerase 1 inhibitor payload - You have received any PTK7-targeted therapy before - You have active hepatitis B, hepatitis C, or HIV infection - You have a history of interstitial lung disease - You have had major surgery, radiation, or systemic cancer treatment within 3 weeks of starting the study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGKIVU-107

KIVU-107 will be administered IV.


Locations(6)

Kivu Trial Site

Santa Monica, California, United States

Kivu Trial Site

Camperdown, New South Wales, 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

View Full Details on ClinicalTrials.gov

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NCT07229313