A Phase 1 Dose-Finding and Dose-Expansion Study of KIVU-107 in Participants With Locally Advanced or Metastatic Solid Tumors
- Study IRB#:2000042905
- Last Updated:09/14/2026
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.
Contact Us
For more information about this study, including how to volunteer, contact:
Ingrid Palma
- Phone Number: 1-203-785-6431
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Trial Purpose and Description
Part A: The primary objective of Part A of this study is to evaluate the safety and tolerability of KIVU-107 and to determine the maximum tolerated dose (MTD)/Recommended Dose for Expansion (RDE).
Part B: The primary objective of Part B of this study is to confirm the safety and tolerability of KIVU-107 at the RDE.
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.
