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Clinical Trials in Australia / NCT07229313
Recruiting Phase 1

A Study of KIVU-107 in Participants With Locally Advanced or Metastatic Solid Tumors

NCT07229313 · tracked via the Priya Life Science Australia tracker
Sponsor
Kivu Bioscience Inc
Phase
Phase 1
Started
2025-11-13
Last updated
2026-09-24

Condition(s) studied

Advance Solid Tumors

Investigational drug(s) / intervention(s)

KIVU-107

KIVU-107: KIVU-107 will be administered IV.

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Part A (Dose Finding): To determine the Maximum Tolerated Dose (MTD) — Up to 18 months
    Number of participants with treatment emergent adverse events
  • Number of participants with treatment related adverse events as assessed by CTCAE version 5.0 — Up to 18 months
  • To evaluate safety and tolerability of KIVU-107 — Up to 30 months
    Number of participants with treatment related adverse events as assessed by CTCAE v5.0

Trial sites (7)

FacilityCityRegionStatus
Kivu Trial Site Santa Monica California Recruiting
Kivu Trial Site New Have Connecticut Recruiting
Kivu Trial Site Camperdown New South Wales Recruiting
Kivu Trial Site Sydney New South Wales Recruiting
Kivu Trial Site Brisbane Queensland Recruiting
Kivu Trial Site Adelaide South Australia Recruiting
Kivu Trial Site Geelong Victoria Recruiting

More Kivu Bioscience Inc. trials in Australia

A Study of KIVU-305 in Participants With Locally Advanced or Metastatic Solid Tumors Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07229313 on ClinicalTrials.gov ↗ ← All trials in Australia