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

Recruiting

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Estimated)

76

Phase

  • 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 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

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
Intervention / Treatment
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

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

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

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

Kivu Bioscience Inc.

Investigators

  • 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)

November 13, 2025

Primary Completion (Estimated)

March 31, 2028

Study Completion (Estimated)

March 31, 2030

Study Registration Dates

First Submitted

September 16, 2025

First Submitted That Met QC Criteria

November 13, 2025

First Posted (Actual)

November 14, 2025

Study Record Updates

Last Update Posted (Actual)

April 16, 2026

Last Update Submitted That Met QC Criteria

April 14, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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