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

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.

Interventions

• KIVU-107 · DRUG

  KIVU-107 will be administered IV.

Published eligibility criteria

Verbatim from the registry. Only the site can decide how these apply to a specific patient.

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.

Sites (6)

• Kivu Trial Site, Santa Monica, California · RECRUITING
• Kivu Trial Site, Camperdown, New South Wales, Australia · RECRUITING
• Kivu Trial Site, Sydney, New South Wales, Australia · RECRUITING
• Kivu Trial Site, Brisbane, Queensland, Australia · RECRUITING
• Kivu Trial Site, Adelaide, South Australia, Australia · RECRUITING
• Kivu Trial Site, Geelong, Victoria, Australia · RECRUITING