76 Participants NeededMy employer runs this trial

KIVU-107 for Cancer

Recruiting at 5 trial locations
KB
KB
Overseen ByKivu Bioscience (Australia)
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called KIVU-107, a potential cancer therapy, to determine its safety and tolerability for individuals with advanced or metastatic solid tumors. These tumors have spread and do not respond to standard treatments. The trial consists of two parts: the first part explores different doses of KIVU-107, while the second part uses the most effective dose identified. Individuals whose cancer has not improved with existing therapies and who have good organ function may be suitable for this study. Participants should not have undergone specific previous cancer treatments or have certain health conditions, such as uncontrolled heart disease. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new therapy.

Do I need to stop my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. However, it mentions that you should not have had major surgery, radiation therapy, or systemic anti-cancer treatment within 3 weeks before starting the study.

Is there any evidence suggesting that KIVU-107 is likely to be safe for humans?

Research has shown that KIVU-107 has a promising safety record in early studies. These studies, often using animals or lab models, found that KIVU-107 has strong anti-tumor effects and was generally well-tolerated. This suggests that KIVU-107 might be safe for humans. However, as this is a Phase 1 trial, it marks the first time KIVU-107 is tested in people. The trial's main goal is to assess its safety for humans. Researchers will closely monitor participants' reactions and any possible side effects.12345

Why do researchers think this study treatment might be promising for cancer?

KIVU-107 is unique because it targets cancer in a novel way by using a new active ingredient that is different from the typical chemotherapy or radiation therapies. Most treatments for cancer, like chemotherapy, work by attacking rapidly dividing cells, which can also harm healthy cells. However, KIVU-107 is designed to specifically target cancer cells with less impact on normal cells, potentially reducing side effects. Researchers are excited about this treatment because it offers a new approach to attacking cancer cells, which could improve effectiveness and patient quality of life. Additionally, the dose-finding and expansion approach in its clinical trial suggests a tailored treatment strategy, aiming for optimal dosing with maximum benefits and minimal risks.

What evidence suggests that KIVU-107 might be an effective treatment for cancer?

Research has shown that KIVU-107 effectively fights tumors in early lab studies. This treatment is a specialized drug targeting a protein commonly found in cancer cells. In these studies, KIVU-107 demonstrated strong tumor-fighting abilities and maintained a good safety record. This trial will focus on KIVU-107 alone, with participants in the Dose Finding arm receiving multiple ascending doses to determine the optimal dose. The Dose Expansion arm will then treat participants with the recommended dose established in the Dose Finding arm. These encouraging results suggest that KIVU-107 could be useful in treating solid tumors.12678

Who Is on the Research Team?

LN

Louie Naumovski, MD, PhD

Principal Investigator

Kivu Bioscience

Are You a Good Fit for This Trial?

This trial is for adults with advanced or metastatic solid tumors (like lung, breast, ovarian, or colon cancer) that haven't responded to standard treatments. Participants must be in good general health, have working major organs, and not have certain infections or recent major procedures.

Inclusion Criteria

I am 18 years old or older.
I am fully active or can do light work despite some symptoms.
Measurable disease using RECIST v1.1
See 4 more

Exclusion Criteria

I have heart disease that is not well controlled.
I have been treated with an ADC drug containing a topoisomerase 1 inhibitor.
I have received PTK7-targeted therapy before.
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Finding

Participants will be treated with KIVU-107 in multiple ascending cohorts to determine the maximum tolerated dose

Up to 18 months

Dose Expansion

Participants will be treated with the recommended dose for expansion (RDE) to confirm safety and tolerability

Up to 30 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • KIVU-107

Trial Overview

The study is testing KIVU-107, a new antibody-drug conjugate targeting PTK7 in people with various advanced cancers. The main goal is to find out if the drug is safe and what dose can be tolerated.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Dose FindingExperimental Treatment1 Intervention
Group II: Dose ExpansionExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Kivu Bioscience Inc.

Lead Sponsor

Citations

Kivu Bioscience Presents Preclinical Data for KIVU-107 ...

Both the oral and poster presentations feature preclinical data highlighting KIVU-107's strong anti-tumor activity, and excellent safety profile ...

Abstract 5649: KIVU-107: A clinical-stage, best-in-class PTK7 ...

KIVU-107 also exhibited enhanced efficacy and improved survival when combined with PARP inhibition, standard-of-care in ovarian, breast and ...

Kivu Bioscience Presents Preclinical Data for KIVU-107 ...

Both the oral and poster presentations feature preclinical data highlighting KIVU-107's strong anti-tumor activity, and excellent safety profile ...

KIVU-107: A clinical-stage, best-in-class PTK7 antibody ...

KIVU-107 also exhibited enhanced efficacy and improved survival when combined with PARP inhibition, standard-of-care in ovarian, breast and ...

Kivu Bioscience Doses First Patient in Phase 1 Trial of ...

We're excited to announce that the first patient has been dosed in our Phase 1 clinical trial of KIVU-107, a next-generation PTK7-targeting ...

Kivu Bioscience unveils preclinical data on KIVU-107

The new preclinical data highlight KIVU-107's strong antitumor activity, and favorable safety profile. In vitro, KIVU-107 demonstrated potent ...

Kivu Bioscience to Present Preclinical Data on Next- ...

Clinical-stage PTK7 ADC KIVU-107 shows strong preclinical anti-tumor activity, favorable pharmacokinetics and improved tolerability.

A Study of KIVU-107 in Participants With Locally Advanced ...

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 ...