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

April 16, 2026 updated by: Kivu Bioscience Inc.

A Phase 1 Dose-Finding and Dose Optimization-Expansion Study of KIVU-305 in Participants With Locally Advanced or Metastatic Solid Tumors

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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
    • Australia
      • Sydney, Australia, Australia
        • 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
  • 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

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
Participants will be treated with KIVU-305 in multiple ascending cohorts
Drug: KIVU-305
KIVU-305 will be administered IV .
Experimental: Dose Expansion
Participants will be treated with the Recommended Dose for Expansion from Dose Finding.
Drug: KIVU-305
KIVU-305 will be administered IV .

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To determine Maximum tolerated dose (MTD)
Time Frame: up to 18 months
Number of participants with treatment emergent adverse events as assessed by CTCAE Version 6.0.
up to 18 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 (Estimated)

June 1, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2029

Study Registration Dates

First Submitted

April 16, 2026

First Submitted That Met QC Criteria

April 16, 2026

First Posted (Actual)

April 22, 2026

Study Record Updates

Last Update Posted (Actual)

April 22, 2026

Last Update Submitted That Met QC Criteria

April 16, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KIVU-305-01

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 may 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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