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NCT Number: NCT07444814

Study Evaluating the Safety and Efficacy of HWK-007, a PTK7-directed Antibody Drug Conjugate in Participants With Advanced Solid Tumors

HWK-007-101 is a multicenter, open-label, first-in-human (FIH) Phase 1 study evaluating HWK-007, a protein tyrosine kinase 7 (PTK7)-targeted antibody drug conjugate (ADC), in adult participants with advanced or metastatic solid tumors known to be expressing PTK7. The study employs a sequential dose escalation and dose expansion design without a control group.

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Key information

Conditions

Endometrial Cancer Adnexal Diseases Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Endocrine Gland Neoplasms Endocrine System Diseases Endometrial Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Non-squamous EGFR Wt NSCLC Ovarian Cancer Ovarian Cancer Metastatic Ovarian Cancer Metastatic Recurrent Ovarian Diseases Ovarian Neoplasms PROC Platinum Resistant Ovarian Cancer Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms Urogenital Diseases Urogenital Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of Arkansas, Little Rock, Arkansas, United States

Loading trial locations.

About this study

The study consists of 2 phases, Phase 1a (dose escalation) and Phase 1b (dose expansion). In Phase 1a, participants with non-squamous Endothelial Growth Factor Receptor Wild type (EGFR Wt) NSCLC, platinum resistant ovarian cancer (PROC), and endometrial cancer will be enrolled. In Phase 1b, non-squamous EGFR Wt NSCLC expansion cohort(s) will be opened, based on the safety, tolerability, PK, and preliminary antitumor data in Phase 1a.

In Phase 1a of the study, HWK-007 will initially be administered as an intravenous (IV) infusion every 3 weeks (Q3W).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Have one of the following solid tumor cancers:

  • Monotherapy escalation and backfill cohorts:
  • non-squamous EGFR-Wt NSCLC
  • Endometrial carcinoma
  • Platinum Resistant Ovarian Cancer
  • Monotherapy expansion cohorts:
  • Non-squamous EGFR-Wt NSCLC
  • Additional tumor indications to be defined in a future amendment

Exclusion criteria

  • Individual with known or suspected uncontrolled central nervous system (CNS) metastases
  • Individual with history of carcinomatous meningitis
  • Individual with active uncontrolled systemic bacterial, viral, fungal, or parasitic infection
  • Individual with evidence of corneal keratopathy or history of cornea transplant
  • Any serious unresolved toxicities from prior therapy
  • Significant cardiovascular disease
  • Prolongation of QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥ 470 milliseconds (ms)
  • History of pneumonitis/interstitial lung disease
  • Individuals who are pregnant, breastfeeding or plan to breastfeed during study or within 30 days of last dose of study intervention

Treatment and study plan

HWK-007

Drug

HWK-007 is a PTK7- targeted ADC being developed for the treatment of solid tumors.

Other names: HWK-007 anti-PTK7 targeted ADC

Primary outcomes

  1. Determine Maximum Tolerated Dose (MTD)

    Time frame: From Cycle 1, Day 1 until Cycle 1, Day 21 (21-day cycles)

    Determine the highest dose of HWK-007 that can be administered without signs of toxicity measured at the end of Cycle 1 (21 day cycle) by: Incidence and severity of Adverse Events (AE). Incidence of Dose-Limiting Toxicities (DLT). Incidence of Serious Adverse Events (SAE).

  2. Determine Maximum Administered Dose (MAD)

    Time frame: From Cycle 1, Day 1 to Cycle 1, Day 21 (21-day cycles) until the MTD is reached.

    Determine the highest dose administered during the dose escalation part of the study measured at the end of Cycle 1 (21 day cycle) by: Incidence and severity of Adverse Events (AE). Incidence of Dose-Limiting Toxicities (DLT). Incidence of Serious Adverse Events (SAE).

  3. Determine the Recommended Dose for Expansion (RDE)

    Time frame: From Cycle 1, Day 1 to Cycle 1, Day 21 (21-day cycles) until MTD is identified.

    Determine the dose that will be recommended for further study within the tumor types studied in this clinical trial measured at the end of Cycle 1 (21 day cycle) by: Incidence and severity of Adverse Events (AE). Incidence of Dose-Limiting Toxicities (DLT). Incidence of Serious Adverse Events (SAE).

Secondary outcomes

  1. Characterize the Volume of Distribution (Vd) of HWK-007 (ADC, total antibody, CPT116, and CPT119)

    Time frame: Cycle 1 and Cycle 4 (21-day cycles)

    Pharmacokinetic analysis of HWK-007 in human subjects

  2. Assess ADA (Anti drug antibody) against HWK-007

    Time frame: Every cycle from Cycle 1, Day 1 (21-day cycles) until 30 days past the last dose of study drug for up to 24 months.

    Using a blood test, determine the risk of developing anti-drug antibodies against HWK-007 following infusion in human patients.

  3. Evaluate the Overall Response Rate (ORR)

    Time frame: From Cycle 1, Day 1 (21-day cycles), every 6-weeks for the first 4 assessments and then every 6 weeks for up to 24 months until disease progression or 24 months, whichever comes first.

    Measure the response rate to the study drug by CT-scans evaluated using RECIST1.1

  4. Evaluate Overall Survival (OS).

    Time frame: From Cycle 1, Day 1 (21-day cycles) until death or 24 months, whichever comes first.

    Measure how long patient lives following treatment with HWK-007

  5. Maximum Concentration - Cmax of HWK-007 (ADC, total antibody, CPT116, and CPT119)

    Time frame: At Cycle 1 and Cycle 4 - (21-day cycles)

    Maximum amount of study drug and drug components in blood following infusion.

  6. Time to Maximum Concentration (Tmax) of HWK-007 (ADC, total antibody, CPT116, and CPT119)

    Time frame: At Cycle 1 and Cycle 4 (21-day cycles).

    Time to reach maximum concentration of drug and drug components in blood following infusion.

  7. Area Under the Concentration Time Curve (AUC) for HWK-007 (ADC, total antibody, CPT116, and CPT119)

    Time frame: Cycle 1 and Cycle 4 - (21-day cycles)

    The total area under the concentration time curve of study drug and drug components following infusion.

  8. T1/2 - Half-life of HWK-007 (ADC, total antibody, CPT116, and CPT119)

    Time frame: Cycle 1 and Cycle 4 (21-day cycles)

    Time for 1/2 of the infused drug to be eliminated/metabolized

  9. Clearance (CL)

    Time frame: Cycle 1 and Cycle 4 (21-day cycles)

    Measured rate at which HWK-007 is cleared from the blood following infusion.

  10. Evaluate the Duration of Response (DoR) to HWK-007

    Time frame: From Cycle 1, Day 1 (21-day cycles) until disease progression or 24 months, whichever comes first.

    Measure the time from evidence of response by CT-scan until evidence of progression of cancer.

  11. Evaluate Progression-free Survival (PFS)

    Time frame: From Cycle 1, Day 1 (21-day cycles) infusion to End of Study (up to 24 months)

    Measure the time from the first infusion of HWK-007 until evidence of cancer progression is detected.

  12. Evaluate Disease control Rate (DCR)

    Time frame: From Cycle 1, Day 1 (21-day cycles) until disease progression or 24 months, whichever comes first.

    Measure the time from Cycle 1, Day 1 that cancer does not worsen by RECIST1.1 criteria.

  13. Time to Response (TTR)

    Time frame: From Cycle 1, Day 1 (21-day cycles) until End of Study or 24 months, whichever comes first.

    Time from Cycle 1, Day 1 infusion of HWK-007 until evidence of response via CT scan according to RECIST1.1 criteria.

Study contacts

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

Central email mailbox - Whitehawk Therapeutics

CONTACT

[email protected]

Clinical Trial Manager Lead

CONTACT

[email protected]

888-392-9025

Sponsors and collaborators

Lead sponsor

Whitehawk Therapeutics, Inc.

Industry

Registry information

Official study title

A Phase 1 First-in-Human Study of PTK7-Directed Antibody Drug Conjugate HWK-007 in Participants With Advanced Solid Tumors

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Mar 3, 2026
Registry last updated
Mar 27, 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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