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NCT Number: NCT07229313

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

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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Key information

Conditions

Advance Solid Tumors Adnexal Diseases Breast Diseases Breast Neoplasms Bronchial Neoplasms Carcinoma Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Carcinoma, Squamous Cell Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Endometrial Neoplasms Esophageal Diseases Esophageal Neoplasms Esophageal Squamous Cell Carcinoma Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Head and Neck Neoplasms Intestinal Diseases Intestinal Neoplasms Lung Diseases Lung Neoplasms Neoplasm Metastasis Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Connective and Soft Tissue Neoplasms, Glandular and Epithelial Neoplasms, Squamous Cell Neoplastic Processes Ovarian Diseases Ovarian Neoplasms Pancreatic Diseases Pancreatic Neoplasms Pathologic Processes Pathological Conditions, Signs and Symptoms Rectal Diseases Respiratory Tract Diseases Respiratory Tract Neoplasms Sarcoma Skin Diseases Skin and Connective Tissue Diseases Small Cell Lung Carcinoma Squamous Cell Carcinoma of Head and Neck Thoracic Neoplasms Triple Negative Breast Neoplasms Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Kivu Trial Site, Camperdown, New South Wales, Australia

Loading trial locations.

About this study

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

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

KIVU-107

Drug

KIVU-107 will be administered IV.

Primary outcomes

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

    Time frame: Up to 18 months

    Number of participants with treatment emergent adverse events

  2. Number of participants with treatment related adverse events as assessed by CTCAE version 5.0

    Time frame: Up to 18 months

  3. To evaluate safety and tolerability of KIVU-107

    Time frame: Up to 30 months

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

Secondary outcomes

  1. 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

  2. Duration of Response (DOR)

    Time frame: Up to 30 months

    Time from CR or PR to objective disease progression or death to any cause

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

    Time frame: Up to 30 months

  4. Maximum Serum concentration of KIVU-107 (Cmax)

    Time frame: 21 days

    PK assessment

  5. Maximum serum concentration of KIVU-107 (Cmin)

    Time frame: 21 days

    PK assessment

  6. Maximum Serum concentration of KIVU-107 at Steady State (Cmax, ss)

    Time frame: up to 168 days

    PK assessment

  7. Minimum Serum Concentration of KIVU-107 at Steady State (Cmin, ss)

    Time frame: up to 168 days

    PK assessment

  8. Time of Maximum Serum Concentration of KIVU-107 (Tmax)

    Time frame: up to 168 days

    PK assessment

  9. Time of Minimum Serum Concentration of KIVU-107 (Tmin)

    Time frame: up to 168 days

    PK assessment

  10. Time of Minimum Serum Concentration of KIVU-107 (Tmin, ss)

    Time frame: Up to 168 days

    PK assessment

  11. Terminal Half-Life (t1/2) of Serum KIVU-107

    Time frame: Up to 168 days

    PK assessment

  12. 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

    PK Assessment

  13. Area under the Serum Concentration-Time curve from the time of dosing extrapolated to time infinity (AUCinf) for KIVU-107

    Time frame: Up to 168 days

    PK Assessment

  14. Clearance (CL) of KIVU-107

    Time frame: Up to 168 days

    PK Assessment

  15. Apparent volume of distribution during the terminal phase (Vz) of KIVU-107

    Time frame: Up to 168 days

    PK Assessment

  16. Accumulation ration (Rac) of KIVU-107

    Time frame: Up to 168 days

    PK Assessment

Other outcomes

  1. 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.

    Time frame: Up to 30 months

  2. 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.

    Time frame: Up to 30 months

  3. Overall Survival (OS)

    Time frame: Up to 30 months

    Proportion of participants alive at 1 year from the start of treatment to death from any cause

  4. Time to Response (TTR)

    Time frame: Up to 30 months

    Time from start of treatment to complete response or partial response

  5. Disease Control Rate (DCR)

    Time frame: Up to 30 months

    Proportion of participants with CR, PR, or SD

Study contacts

Contact information is provided by the study sponsor or research team.

Kivu Bioscience (Australia)

CONTACT

[email protected]

+61 8 7223 0122

Kivu Bioscience (US)

CONTACT

[email protected]

+1.650.606.5170

Sponsors and collaborators

Lead sponsor

Kivu Bioscience Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2028
Study completion
2030
First posted
Nov 14, 2025
Registry last updated
Apr 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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