NCT07229313

Brief 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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
76

participants targeted

Target at P75+ for phase_1

Timeline
47mo left

Started Nov 2025

Longer than P75 for phase_1

Geographic Reach
2 countries

6 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress11%
Nov 2025Mar 2030

First Submitted

Initial submission to the registry

September 16, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

November 13, 2025

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 14, 2025

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2028

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2030

Last Updated

April 16, 2026

Status Verified

April 1, 2026

Enrollment Period

2.4 years

First QC Date

September 16, 2025

Last Update Submit

April 14, 2026

Conditions

Advance Solid Tumors

Keywords

PTK7ADCsolid tumorsPTK-7 expressionmetastaticlocally advancedPTK7 expressionendometrial cancerovarian cancerbreast cancercervical cancerGI/GEJ adenocarcinomaesophageal squamous cell cancercolorectal cancerpancreatic cancernon-small cell lung cancersmall cell lung cancerhead and neck squamous cell carcinomasarcomaOvCaNSCLCSCLCCRCPDACHNSCCTNBCtriple negative breast cancerantibody drug conjugate

Outcome Measures

Primary Outcomes (3)

  • Part A (Dose Finding): To determine the Maximum Tolerated Dose (MTD)

    Number of participants with treatment emergent adverse events

    Up to 18 months

  • 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

    Number of participants with treatment related adverse events as assessed by CTCAE v5.0

    Up to 30 months

Secondary Outcomes (16)

  • Objective Response Rate (ORR) is percentage of participants with best response of complete response (CR) or partial response (PR) according to RECIST 1.1

    Up to 30 months

  • Duration of Response (DOR)

    Up to 30 months

  • To evaluate the immunogenicity as measured by change of anti-drug antibodies in participants treated with KIVU-107

    Up to 30 months

  • Maximum Serum concentration of KIVU-107 (Cmax)

    21 days

  • Maximum serum concentration of KIVU-107 (Cmin)

    21 days

  • +11 more secondary outcomes

Other Outcomes (5)

  • To evaluate biomarkers with potential to predict response and/or resistance to KIVU-107 characterize baseline levels and/ or changes in genomic, mRNA and/or protein biomarkers to determine any signatures correlated with response or resistance.

    Up to 30 months

  • Progression Free Survival (PFS) is defined as the time from the first dose to either disease progression according to RECIST v. 1.1, or death due to any cause, whichever comes first.

    Up to 30 months

  • Overall Survival (OS)

    Up to 30 months

  • +2 more other outcomes

Study Arms (2)

Dose Finding

EXPERIMENTAL

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

Drug: KIVU-107

Dose Expansion

EXPERIMENTAL

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

Drug: KIVU-107

Interventions

KIVU-107DRUG

KIVU-107 will be administered IV.

Dose ExpansionDose Finding

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Kivu Trial Site

Santa Monica, California, 90403, United States

RECRUITING

Kivu Trial Site

Camperdown, New South Wales, 2050, 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

MeSH Terms

Conditions

Neoplasm MetastasisEndometrial NeoplasmsOvarian NeoplasmsBreast NeoplasmsUterine Cervical NeoplasmsEsophageal Squamous Cell CarcinomaColorectal NeoplasmsPancreatic NeoplasmsCarcinoma, Non-Small-Cell LungSmall Cell Lung CarcinomaSquamous Cell Carcinoma of Head and NeckSarcomaTriple Negative Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplastic ProcessesNeoplasmsPathologic ProcessesPathological Conditions, Signs and SymptomsUterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesEndocrine Gland NeoplasmsOvarian DiseasesAdnexal DiseasesEndocrine System DiseasesGonadal DisordersBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesUterine Cervical DiseasesCarcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms, Squamous CellEsophageal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal DiseasesIntestinal NeoplasmsColonic DiseasesIntestinal DiseasesRectal DiseasesPancreatic DiseasesCarcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsLung DiseasesRespiratory Tract DiseasesNeoplasms, Connective and Soft Tissue

Study Officials

  • Louie Naumovski, MD, PhD

    Kivu Bioscience

    STUDY CHAIR

Central Study Contacts

Kivu Bioscience (US)

CONTACT

+1.650.606.5170KIVU10701@kivubioscience.com

Kivu Bioscience (Australia)

CONTACT

+61 8 7223 0122KIVU10701@kivubioscience.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 16, 2025

First Posted

November 14, 2025

Study Start

November 13, 2025

Primary Completion (Estimated)

March 31, 2028

Study Completion (Estimated)

March 31, 2030

Last Updated

April 16, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

We are committed to enhancing public health through responsible sharing of clinical trial data. Following approval of a new product or a new indication for an approved product, the study sponsor and/or its affiliated companies will share study protocols, anonymized patient data and study level data, and redacted clinical study reports with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research.

Locations

AU(5)US(1)