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RecruitingPhase 1

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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests the safety of KIVU-107 and how well people can handle it. KIVU-107 is an antibody linked to a cancer drug that targets a protein called PTK7. It is being tested in humans for the first time, in adults with solid tumors that have grown nearby or spread to other parts of the body.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are age 18 or older.
  • No treatment known to work is available for your tumor.
  • Lab tests of cells or tissue confirm a solid tumor that has grown nearby or spread. Standard treatment has not worked, or none is available.
  • Your bone marrow, kidneys, and liver work well enough.
  • Your cancer can be measured using the study’s rules.
  • You can do all usual activities, or you can do light work but have trouble with hard physical activity.
  • You are expected to live at least 3 months.

Who can't join

  • You have had an antibody-drug conjugate (an antibody linked to a drug) carrying a topoisomerase 1 inhibitor, a type of cancer drug.
  • You have had any treatment that targets PTK7.
  • You have heart or blood vessel disease that is not controlled.
  • You have an active hepatitis B, hepatitis C, or HIV infection.
  • You have a history of interstitial lung disease, which causes swelling or scarring in the lungs.
  • You had major surgery, radiation, or cancer medicine that treats the whole body within 3 weeks before starting study treatment.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 sites (2)

CA

CT