A Study of KIVU-107 in Participants With Locally Advanced or Metastatic Solid Tumors
Phase 1 – testing safety in a small group of people
Conditions:
Advance Solid Tumors
Sponsor: Kivu Bioscience Inc.
trial.available_in:
БГ
Overview
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.
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.
Who can participate
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.