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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-13

Study Completion Date

2030-03-31

Brief Summary

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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.

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Detailed Description

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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

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Advance Solid Tumors

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Dose Finding

Part A: KIVU-107 Dose Finding - Participants will be treated with KIVU-107 in multiple ascending cohorts.

Group Type EXPERIMENTAL

KIVU-107

Intervention Type DRUG

KIVU-107 will be administered IV.

Dose Expansion

Part B: KIVU-107 Dose Expansion - Participants will be treated with the RDE from Part A.

Group Type EXPERIMENTAL

KIVU-107

Intervention Type DRUG

KIVU-107 will be administered IV.

Interventions

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KIVU-107

KIVU-107 will be administered IV.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No