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
- Advance Solid Tumors
At a glance
- Phase
- Phase 1
- Study type
- Interventional
- Sponsor
- Kivu Bioscience Inc.
- Enrolment target
- 76
- Started
- 13 November 2025
- Main results due
- 31 March 2028
- Study sites
- 7
- Registry updated
- 24 September 2026
Can you take part?
- Aged 18 years and over.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full 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.
What this study is about
In the sponsor’s own words, from the registry.
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.
Study sites(7)
Kivu Trial Site
Santa Monica, California, United States
Recruiting
Kivu Trial Site
New Have, Connecticut, United States
Recruiting
Kivu Trial Site
Camperdown, New South Wales, Australia
Recruiting
Kivu Trial Site
Sydney, New South Wales, Australia
Recruiting
Kivu Trial Site
Brisbane, Queensland, Australia
Recruiting
Kivu Trial Site
Adelaide, South Australia, Australia
Recruiting
Kivu Trial Site
Geelong, Victoria, Australia
Recruiting
Showing 7 of 7 sites. 7 of the 7 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT07229313. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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