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New Antibody-Drug conjugate KIVU-107 enters first human trials for Hard-to-Treat cancers

NCT ID NCT07229313

Disease control Sponsor: Kivu Bioscience Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-stage trial tests a new drug called KIVU-107 in 76 adults with advanced solid tumors that have not responded to standard treatments. KIVU-107 is an antibody-drug conjugate designed to target and kill cancer cells. The main goal is to find a safe dose and check for side effects.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
KIVU-107 (an antibody-drug conjugate targeting PTK7)
What this could lead to
If successful, this could lead to a new treatment option for people with advanced solid tumors that have not responded to other therapies.
What could go wrong
This is a very early (Phase 1) and small trial (76 people), so safety and effectiveness are not yet known. The drug may cause side effects or not shrink tumors.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 76 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2025

Expected to finish

Mar 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm cervical cancer colorectal cancer colorectal neoplasm endometrial cancer endometrium neoplasm esophageal squamous cell carcinoma gastroesophageal junction adenocarcinoma head and neck squamous cell carcinoma malignant pancreatic neoplasm Neoplasm Metastasis non-small cell lung carcinoma ovarian cancer pancreatic neoplasm sarcoma small cell lung carcinoma Squamous Cell Carcinoma of Head and Neck triple-negative breast carcinoma Uterine Cervical Neoplasms

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Advance solid tumors Breast cancer Cervical cancer Colorectal cancer Endometrial cancer Esophageal squamous cell cancer Gastric/gastroesophageal junction adenocarcinoma Head and neck squamous cell carcinoma Non-small cell lung cancer Ovarian cancer (OVCA) Pancreatic cancer Sarcoma Small cell lung cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    6 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Kivu Trial Site

    RECRUITING

    Santa Monica, California, 90403, United States

  • Kivu Trial Site

    RECRUITING

    Camperdown, New South Wales, 2050, Australia

  • Kivu Trial Site

    RECRUITING

    Sydney, New South Wales, Australia

  • Kivu Trial Site

    RECRUITING

    Brisbane, Queensland, Australia

  • Kivu Trial Site

    RECRUITING

    Adelaide, South Australia, Australia

  • Kivu Trial Site

    RECRUITING

    Geelong, Victoria, Australia

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