NCT07229313RecruitingPhase 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
Source: ClinicalTrials.gov · Last updated 24 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 76 (estimated)
- First submitted
- 16 Sept 2025
- Start date
- 13 Nov 2025
- Primary completion date
- 31 Mar 2028
- Lead sponsor
- Kivu Bioscience Inc.
- Diseases
- Head and neck cancer, Cervical cancer, Endometrial cancer, Triple-negative breast cancer, Sarcoma, Lung cancer, Pancreatic cancer, Colorectal cancer, Gastric and esophageal cancer, Ovarian cancer
- NCT number
- NCT07229313
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 76
- From 13 Nov 2025 to the primary completion date, 31 Mar 2028
- 7 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior treatment with any ADC with topoisomerase 1 inhibitor payload
- Any PTK7 - targeted therapy
Other illness
- 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.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (7)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| - Coordinator of this site? Confirm its status | Adelaide | Australia | Recruiting |
| - Coordinator of this site? Confirm its status | Brisbane | Australia | Recruiting |
| - Coordinator of this site? Confirm its status | Camperdown | Australia | Recruiting |
| - Coordinator of this site? Confirm its status | Geelong | Australia | Recruiting |
| - Coordinator of this site? Confirm its status | Sydney | Australia | Recruiting |
| - Coordinator of this site? Confirm its status | New Have | United States | Recruiting |
| - Coordinator of this site? Confirm its status | Santa Monica | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.