RecruitingPhase 1NCT07229313
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
Sponsor
Kivu Bioscience Inc.
Enrollment
76 participants
Start Date
Nov 13, 2025
Study Type
INTERVENTIONAL
Conditions
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
Min Age: 18 Years
Inclusion Criteria7
- 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 Criteria6
- 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.
Interventions
DRUGKIVU-107
KIVU-107 will be administered IV.
Locations(4)
View Full Details on ClinicalTrials.gov
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NCT07229313