NCT07229313 A Study of KIVU-107 in Participants With Locally Advanced or Metastatic Solid Tumors
| NCT ID | NCT07229313 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Kivu Bioscience Inc. |
| Condition | Advance Solid Tumors |
| Study Type | INTERVENTIONAL |
| Enrollment | 76 participants |
| Start Date | 2025-11-13 |
| Primary Completion | 2028-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 76 participants in total. It began in 2025-11-13 with a primary completion date of 2028-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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.
Contact & Investigator
Louie Naumovski, MD, PhD
STUDY CHAIR
Kivu Bioscience
Frequently Asked Questions
Who can join the NCT07229313 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Advance Solid Tumors. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07229313 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07229313 currently recruiting?
Yes, NCT07229313 is actively recruiting participants. Contact the research team at KIVU10701@kivubioscience.com for enrollment information.
Where is the NCT07229313 trial being conducted?
This trial is being conducted at Santa Monica, United States, Camperdown, Australia, Sydney, Australia, Brisbane, Australia and 2 additional locations.
Who is sponsoring the NCT07229313 clinical trial?
NCT07229313 is sponsored by Kivu Bioscience Inc.. The principal investigator is Louie Naumovski, MD, PhD at Kivu Bioscience. The trial plans to enroll 76 participants.