NCT07229313

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 76 (estimated)
• Sponsor: Kivu Bioscience Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Advance Solid Tumors

Interventions

Type	Name	Description
DRUG	KIVU-107	KIVU-107 will be administered IV.

Timeline

• Start date: 2025-11-13
• Primary completion: 2028-03-31
• Completion: 2030-03-31
• First posted: 2025-11-14
• Last updated: 2026-04-16

Locations

6 sites across 2 countries: United States, Australia

Regulatory

• FDA-regulated drug study