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

April 14, 2026 updated by: Kivu Bioscience Inc.

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Part A: The primary objective of Part A of this study is to evaluate the safety and tolerability of KIVU-107 and to determine the maximum tolerated dose (MTD)/Recommended Dose for Expansion (RDE).

Part B: The primary objective of Part B of this study is to confirm the safety and tolerability of KIVU-107 at the RDE.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
76

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Australia
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
        • Recruiting
        • Kivu Trial Site
      • Sydney, New South Wales, Australia
        • Recruiting
        • Kivu Trial Site
    • Queensland
      • Brisbane, Queensland, Australia
        • Recruiting
        • Kivu Trial Site
    • South Australia
      • Adelaide, South Australia, Australia
        • Recruiting
        • Kivu Trial Site
    • Victoria
      • Geelong, Victoria, Australia
        • Recruiting
        • Kivu Trial Site
  • United States
    • California
      • Santa Monica, California, United States, 90403
        • Recruiting
        • Kivu Trial Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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 Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Dose Finding
Part A: KIVU-107 Dose Finding - Participants will be treated with KIVU-107 in multiple ascending cohorts.
Drug: KIVU-107
KIVU-107 will be administered IV.
Experimental: Dose Expansion
Part B: KIVU-107 Dose Expansion - Participants will be treated with the RDE from Part A.
Drug: KIVU-107
KIVU-107 will be administered IV.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Part A (Dose Finding): To determine the Maximum Tolerated Dose (MTD)
Time Frame: Up to 18 months
Number of participants with treatment emergent adverse events
Up to 18 months
Number of participants with treatment related adverse events as assessed by CTCAE version 5.0
Time Frame: Up to 18 months
Up to 18 months
To evaluate safety and tolerability of KIVU-107
Time Frame: Up to 30 months
Number of participants with treatment related adverse events as assessed by CTCAE v5.0
Up to 30 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Objective Response Rate (ORR) is percentage of participants with best response of complete response (CR) or partial response (PR) according to RECIST 1.1
Time Frame: Up to 30 months
Up to 30 months
Duration of Response (DOR)
Time Frame: Up to 30 months
Time from CR or PR to objective disease progression or death to any cause
Up to 30 months
To evaluate the immunogenicity as measured by change of anti-drug antibodies in participants treated with KIVU-107
Time Frame: Up to 30 months
Up to 30 months
Maximum Serum concentration of KIVU-107 (Cmax)
Time Frame: 21 days
PK assessment
21 days
Maximum serum concentration of KIVU-107 (Cmin)
Time Frame: 21 days
PK assessment
21 days
Maximum Serum concentration of KIVU-107 at Steady State (Cmax, ss)
Time Frame: up to 168 days
PK assessment
up to 168 days
Minimum Serum Concentration of KIVU-107 at Steady State (Cmin, ss)
Time Frame: up to 168 days
PK assessment
up to 168 days
Time of Maximum Serum Concentration of KIVU-107 (Tmax)
Time Frame: up to 168 days
PK assessment
up to 168 days
Time of Minimum Serum Concentration of KIVU-107 (Tmin)
Time Frame: up to 168 days
PK assessment
up to 168 days
Time of Minimum Serum Concentration of KIVU-107 (Tmin, ss)
Time Frame: Up to 168 days
PK assessment
Up to 168 days
Terminal Half-Life (t1/2) of Serum KIVU-107
Time Frame: Up to 168 days
PK assessment
Up to 168 days
Area under the Serum Concentration-Time curve from the time of dosing to the last measurable concentration (AUClast) for KIVU-107
Time Frame: 21 days
PK Assessment
21 days
Area under the Serum Concentration-Time curve from the time of dosing extrapolated to time infinity (AUCinf) for KIVU-107
Time Frame: Up to 168 days
PK Assessment
Up to 168 days
Clearance (CL) of KIVU-107
Time Frame: Up to 168 days
PK Assessment
Up to 168 days
Apparent volume of distribution during the terminal phase (Vz) of KIVU-107
Time Frame: Up to 168 days
PK Assessment
Up to 168 days
Accumulation ration (Rac) of KIVU-107
Time Frame: Up to 168 days
PK Assessment
Up to 168 days

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
To evaluate biomarkers with potential to predict response and/or resistance to KIVU-107 characterize baseline levels and/ or changes in genomic, mRNA and/or protein biomarkers to determine any signatures correlated with response or resistance.
Time Frame: Up to 30 months
Up to 30 months
Progression Free Survival (PFS) is defined as the time from the first dose to either disease progression according to RECIST v. 1.1, or death due to any cause, whichever comes first.
Time Frame: Up to 30 months
Up to 30 months
Overall Survival (OS)
Time Frame: Up to 30 months
Proportion of participants alive at 1 year from the start of treatment to death from any cause
Up to 30 months
Time to Response (TTR)
Time Frame: Up to 30 months
Time from start of treatment to complete response or partial response
Up to 30 months
Disease Control Rate (DCR)
Time Frame: Up to 30 months
Proportion of participants with CR, PR, or SD
Up to 30 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kivu Bioscience Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Louie Naumovski, MD, PhD, Kivu Bioscience

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 13, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 16, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 13, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 14, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 16, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 14, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • KIVU-107-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

We are committed to enhancing public health through responsible sharing of clinical trial data. Following approval of a new product or a new indication for an approved product, the study sponsor and/or its affiliated companies will share study protocols, anonymized patient data and study level data, and redacted clinical study reports with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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