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Recruiting NCT07229313

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

Phase I Interventional Advance Solid Tumors

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: KIVU-107.
Who it may be relevant to
Registry conditions: Advance Solid Tumors. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Australia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Phase 1 Dose-Finding and Dose-Expansion Study of KIVU-107 in Participants With Locally Advanced or Metastatic Solid Tumors

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.

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.

Interventions

  • Drug KIVU-107
    KIVU-107 will be administered IV.

Primary outcome measures

  • Part A (Dose Finding): To determine the Maximum Tolerated Dose (MTD) [Time frame: Up to 18 months]
  • Number of participants with treatment related adverse events as assessed by CTCAE version 5.0 [Time frame: Up to 18 months]
  • To evaluate safety and tolerability of KIVU-107 [Time frame: Up to 30 months]
Secondary outcome measures (12)
  • Objective Response Rate (ORR) is percentage of participants with best response of complete response (CR) or partial response (PR) according to RECIST 1.1 [Time frame: Up to 30 months]
  • Duration of Response (DOR) [Time frame: Up to 30 months]
  • To evaluate the immunogenicity as measured by change of anti-drug antibodies in participants treated with KIVU-107 [Time frame: Up to 30 months]
  • Maximum Serum concentration of KIVU-107 (Cmax) [Time frame: 21 days]
  • Maximum serum concentration of KIVU-107 (Cmin) [Time frame: 21 days]
  • Maximum Serum concentration of KIVU-107 at Steady State (Cmax, ss) [Time frame: up to 168 days]
  • Minimum Serum Concentration of KIVU-107 at Steady State (Cmin, ss) [Time frame: up to 168 days]
  • Time of Maximum Serum Concentration of KIVU-107 (Tmax) [Time frame: up to 168 days]
  • Time of Minimum Serum Concentration of KIVU-107 (Tmin) [Time frame: up to 168 days]
  • Time of Minimum Serum Concentration of KIVU-107 (Tmin, ss) [Time frame: Up to 168 days]
  • Terminal Half-Life (t1/2) of Serum KIVU-107 [Time frame: Up to 168 days]
  • Area under the Serum Concentration-Time curve from the time of dosing to the last measurable concentration (AUClast) for KIVU-107 [Time frame: 21 days]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

Australia · 5 centers
  • Kivu Trial Site — Camperdown
  • Kivu Trial Site — Sydney
  • Kivu Trial Site — Brisbane
  • Kivu Trial Site — Adelaide
  • Kivu Trial Site — Geelong
United States · 1 center
  • Kivu Trial Site — Santa Monica

Identifiers

NCT: NCT07229313 · KIVU-107-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗