A Study of KIVU-107 in Participants With Locally Advanced or Metastatic Solid Tumors
Recruiting · NCT07229313 · Interventional (participants receive a specific treatment) · Lead sponsor: Kivu Bioscience Inc.
View the official record on ClinicalTrials.gov →Interventions studied
KIVU-107
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
24 locations listed across 1 US state.
- Kivu Trial Site - Santa Monica, California, United States
- Kivu Trial Site - Santa Monica, California, United States
- Kivu Trial Site - Santa Monica, California, United States
- Kivu Trial Site - Santa Monica, California, United States
- Kivu Trial Site - Camperdown, New South Wales, Australia
- Kivu Trial Site - Camperdown, New South Wales, Australia
- Kivu Trial Site - Camperdown, New South Wales, Australia
- Kivu Trial Site - Camperdown, New South Wales, Australia
- Kivu Trial Site - Sydney, New South Wales, Australia
- Kivu Trial Site - Sydney, New South Wales, Australia
- Kivu Trial Site - Sydney, New South Wales, Australia
- Kivu Trial Site - Sydney, New South Wales, Australia
- Kivu Trial Site - Brisbane, Queensland, Australia
- Kivu Trial Site - Brisbane, Queensland, Australia
- Kivu Trial Site - Brisbane, Queensland, Australia
- Kivu Trial Site - Brisbane, Queensland, Australia
- Kivu Trial Site - Adelaide, South Australia, Australia
- Kivu Trial Site - Adelaide, South Australia, Australia
- Kivu Trial Site - Adelaide, South Australia, Australia
- Kivu Trial Site - Adelaide, South Australia, Australia
- Kivu Trial Site - Geelong, Victoria, Australia
- Kivu Trial Site - Geelong, Victoria, Australia
- Kivu Trial Site - Geelong, Victoria, Australia
- Kivu Trial Site - Geelong, Victoria, Australia