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RecruitingLast updated: 24 April 2026

KIVU-107-01: Testing how safe and effective a new medicine called KIVU-107 is in people with locally advanced or metastatic solid cancersA Phase 1 Dose-Finding and Dose-Expansion Study of KIVU-107 in Participants With Locally Advanced or Metastatic Solid Tumors

Trial purpose

Medical clipboardCancer treatment

Tumor type

Multi-Cancer Multi-Cancer

Age

People18+

Trial acronym

KIVU-107-01

Clinical summary

Summary

This is a 2-part, first-in-human study to determine how safe and tolerable a targeted medicine called KIVU-107 is in people with locally advanced or metastatic solid cancers. You may be eligible if your tumour is resistant to standard treatment or has no standard therapy available.

In Part A different dose levels of KIVU-107 will be tested to determine the maximum tolerate dose and the dose level that should be further studies.

In Part B, the dose level identified in Part A will be further assessed.

Conditions

This trial is treating people with locally advanced or metastatic solid cancers

Eligibility

Inclusion

  • 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

  • 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.

Inclusion

  • Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
  • Your cancer has not spread to other parts of the body, but it is not possible to perform surgery to remove it (unresectable).
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

Participating hospitals

Recruiting hospitals

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More information

Trial Identifiers

Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:

Trial sponsor

Kivu Bioscience Inc.

Scientific Title

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

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