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

Recruiting now · Phase 1

Conditions studied: Advance Solid Tumors

In brief

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.

Key facts

Study ID

NCT07229313

Run by

Kivu Bioscience Inc.

People needed

76

Starts

2025-11-13

Expected to finish

2030-03-31

Last updated by the study team

2026-04-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Kivu Trial Site — Santa Monica, California, United States (enrolling)
• Kivu Trial Site — Camperdown, New South Wales, Australia (enrolling)
• Kivu Trial Site — Sydney, New South Wales, Australia (enrolling)
• Kivu Trial Site — Brisbane, Queensland, Australia (enrolling)
• Kivu Trial Site — Adelaide, South Australia, Australia (enrolling)
• Kivu Trial Site — Geelong, Victoria, Australia (enrolling)

Full record on ClinicalTrials.gov

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