A Study of KIVU-305 in Participants With Locally Advanced or Metastatic Solid Tumors

Starting soon · Phase 1

Conditions studied: Solid Tumors

In brief

This is a 2-part, first-in-human, open-label study to determine the safety, tolerability and preliminary efficacy of KIVU-305, a CEACAM5-directed antibody-drug conjugate, in participants with locally advanced or metastatic solid tumors.

Key facts

Study ID

NCT07545356

Run by

Kivu Bioscience Inc.

People needed

76

Starts

2026-06-01

Expected to finish

2029-12-01

Last updated by the study team

2026-07-10

Who can join

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

You may qualify if…

• Male or female ≥18 years of age
• 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 a topoisomerase 1 inhibitor payload
• Prior treatment with any CEACAM5 targeted therapy
• Uncontrolled cardiovascular disease
• Uncontrolled 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 — Sydney, New South Wales, Australia
• Kivu Trial Site — Wollongong, New South Wales, Australia
• Kivu Trial Site — Brisbane, Queensland, Australia

Full record on ClinicalTrials.gov

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