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Study of KIVU-107 for Advanced Solid Tumors

This study is testing a new treatment called KIVU-107 for people with advanced solid tumors (cancers that have spread or are difficult to treat). KIVU-107 is an antibody-drug conjugate, which means it's designed to target cancer cells more directly. The main goals are to find a safe dose of KIVU-107 and to see how well people tolerate it. You might be able to join if you are at least 18 years old, have an advanced solid tumor that hasn't responded to standard treatments or for which no standard treatment exists, and have good organ function. The study will look at side effects and how safe the treatment is over time.

Study design
This is an open-label study, meaning you and your doctors will know what treatment you are receiving. It aims to enroll 76 participants to evaluate the safety and tolerability of KIVU-107.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study will monitor for side effects for up to 30 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07229313

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
Kivu Bioscience Inc.
~76 participants
Updated 2026-04-16 on ClinicalTrials.gov
What's tested:KIVU-107

At a glance

Recruiting sites
6 of 6 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Part A (Dose Finding): To determine the Maximum Tolerated Dose (MTD)
Measured over Up to 18 months
+2 more outcomes measured

Conditions

Advance Solid Tumors

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Where it's being run

6 sites across 5 states
New South Wales2
California1
Queensland1
South Australia1
Victoria1

Study leadership

  • Louie Naumovski, MD, PhD · STUDY_CHAIR · Kivu Bioscience

Who to contact

Kivu Bioscience (US)
[email protected]
+1.650.606.5170
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

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.

What this trial measures

  • Part A (Dose Finding): To determine the Maximum Tolerated Dose (MTD)Up to 18 months

    Number of participants with treatment emergent adverse events

  • Number of participants with treatment related adverse events as assessed by CTCAE version 5.0Up to 18 months
  • To evaluate safety and tolerability of KIVU-107Up to 30 months

    Number of participants with treatment related adverse events as assessed by CTCAE v5.0