KIVU-107 for people with locally advanced or metastatic solid tumors
Official title: A Phase 1 Dose-Finding and Dose-Expansion Study of KIVU-107 in Participants With Locally Advanced or Metastatic Solid Tumors
Run by Kivu Bioscience Inc. · NCT07229313 · Data updated 2026-11-12
This trial will test KIVU-107, a PTK7-targeted antibody–drug conjugate, in adults with locally advanced or metastatic solid tumors that lack effective standard treatment.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 76 (estimated) |
| Sponsor | Kivu Bioscience Inc. Industry-sponsored |
| Drugs / interventions | radiation |
| Locations | 7 sites (Santa Monica, California and 6 other locations) |
| Status | Recruiting |
| Started | November 13, 2025 |
| Main results expected | March 31, 2028 |
| Study ends | March 31, 2030 |
| Registry record updated | September 24, 2026 |
| Trial ID | NCT07229313 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18) with pathologically confirmed locally advanced or metastatic solid tumors refractory to standard therapies, measurable disease, ECOG 0–1, adequate organ function, and no prior PTK7-targeted therapy or topoisomerase I ADC exposure are ideal candidates.
✕Probably not a fit
Patients with prior treatment using topoisomerase I–payload ADCs or PTK7-targeted therapies, active hepatitis B/C or HIV infection, uncontrolled cardiovascular disease, interstitial lung disease, or recent major surgery/radiation may be excluded or less likely to benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is an open-label, first-in-human Phase 1 study of KIVU-107 conducted in two parts. Part A uses dose-escalation to determine the maximum tolerated dose and the recommended dose for expansion while closely monitoring safety, tolerability, and preliminary anti-tumor activity. Part B treats additional participants at the recommended dose to further confirm safety and tolerability. Eligible adults must have measurable disease, ECOG 0–1, adequate organ function, and no prior PTK7-targeted therapy or exposure to topoisomerase I–payload ADCs.
Why it matters
Potential benefit: If successful, KIVU-107 could provide a new targeted treatment option for patients with PTK7-expressing advanced solid tumors, potentially shrinking tumors or delaying progression.
How similar studies have gone: Other PTK7-targeted agents have been explored preclinically and in early-phase work, but KIVU-107 is first-in-human and its clinical benefit has not yet been established.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
-
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
Show 1 more location
-
Kivu Trial Site
Geelong, Victoria, Australia Recruiting
Study contacts
- Study coordinator: Kivu Bioscience (US)
- Email: KIVU10701@kivubioscience.com
- Phone: +1.650.606.5170
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
JMBI-001 in MYC-Positive Advanced Cancers
This study tests JMBI-001 to see if it is safe and tolerable for adults with MYC-positive advanced cancers.
-
INV-8989 in KRAS G12D-mutant advanced solid tumors
This study tests INV-8989 to see if it can be safely given and potentially help patients with KRAS G12D-mutant advanced solid tumors.
-
KIVU-305 for advanced solid tumors
This first-in-human study tests KIVU-305, a CEACAM5-targeted antibody-drug conjugate, in adults with locally advanced or metastatic solid tumors that have no good standard options left or are resistant to current therapies.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.