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

RecruitingPhase 1Ages 18 Years - anyAllKivu Bioscience Inc.
NCT07545356 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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 Exclusion Criteria: * 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
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What it tests

  • KIVU-305
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Where

3 sites
Kivu Trial Site
Sydney, Australia
Kivu Trial Site
Wollongong, Australia
Kivu Trial Site
Brisbane, Australia
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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