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

March 26, 2026 updated by: Whitehawk Therapeutics, Inc.

A Phase 1 First-in-Human Study of PTK7-Directed Antibody Drug Conjugate HWK-007 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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).

Study Type

Interventional

Enrollment (Estimated)

226

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72205-7199
        • Not yet recruiting
        • University of Arkansas
        • Principal Investigator:
          • Michael Birrer, MD
        • Contact:
    • California
      • Los Angeles, California, United States, 90095
        • Not yet recruiting
        • UCLA - Hematology/Oncology Clinical Research Unit
        • Principal Investigator:
          • Aaron Lisberg, MD
        • Contact:
    • Illinois
      • Peoria, Illinois, United States, 61637
        • Not yet recruiting
        • St. Francis Medical Center (OSF Healthcare)
        • Contact:
        • Principal Investigator:
          • Michelle Rowland, MD
    • Michigan
      • Grand Rapids, Michigan, United States, 49546
        • Recruiting
        • START - Midwest
        • Principal Investigator:
          • Manish Sharma
        • Contact:
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Not yet recruiting
        • Hackensack University Medical Center - John Theurer Cancer Center
        • Contact:
        • Principal Investigator:
          • Miguel Gonzalez, MD
    • New York
      • Buffalo, New York, United States, 14263
        • Not yet recruiting
        • Roswell Park Comprehensive Care Center
        • Contact:
        • Principal Investigator:
          • Bailey Fitzgerald, MD
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Not yet recruiting
        • University Hospital - Cleveland Medical Center
        • Contact:
          • C
        • Contact:
        • Principal Investigator:
          • Matthew Mirsky, MD
    • Texas
      • Austin, Texas, United States, 78758
        • Recruiting
        • Next Oncology - Austin
        • Contact:
      • Houston, Texas, United States, 77054
        • Recruiting
        • NEXT - Oncology - Houston
        • Principal Investigator:
          • Jennifer Segar, MD
        • Contact:
      • San Antonio, Texas, United States, 78229
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Recruiting
        • NEXT Oncology - Virginia Cancer Specialists
        • Principal Investigator:
          • Alexander Spira, MD, PhD
        • Contact:
    • Washington
      • Seattle, Washington, United States, 98109
        • Not yet recruiting
        • Fred Hutchinson Cancer Center
        • Contact:
          • C
        • Principal Investigator:
          • Lei Deng, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Have one of the following solid tumor cancers:

  1. Monotherapy escalation and backfill cohorts:

    1. non-squamous EGFR-Wt NSCLC
    2. Endometrial carcinoma
    3. Platinum Resistant Ovarian Cancer

  2. Monotherapy expansion cohorts:

    1. Non-squamous EGFR-Wt NSCLC
    2. Additional tumor indications to be defined in a future amendment

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dose Escalation - 21 Day treatment cycle
Escalating doses of HWK-007 administered intravenously (IV)
Drug: HWK-007
HWK-007 is a PTK7- targeted ADC being developed for the treatment of solid tumors.
Other Names:
  • HWK-007 anti-PTK7 targeted ADC
Experimental: Dose Expansion Group 1- 21-day treatment cycle - non-squamous EGFR-WT NSCLC
Expanded enrolment at selected dose of HWK-007 in NSCLC.
Drug: HWK-007
HWK-007 is a PTK7- targeted ADC being developed for the treatment of solid tumors.
Other Names:
  • HWK-007 anti-PTK7 targeted ADC
Experimental: Dose Expansion Group 2 - 21-day treatment cycle - Tumor TBD
Expanded enrolment at second selected dose of HWK-007 administered intravenously (IV) in Tumor - TBD
Drug: HWK-007
HWK-007 is a PTK7- targeted ADC being developed for the treatment of solid tumors.
Other Names:
  • HWK-007 anti-PTK7 targeted ADC
Experimental: Dose Expansion Group 3 - 21-day treatment cycle - Tumor TBD
Expanded enrolment at third selected dose in Tumor - TBD
Drug: HWK-007
HWK-007 is a PTK7- targeted ADC being developed for the treatment of solid tumors.
Other Names:
  • HWK-007 anti-PTK7 targeted ADC
Experimental: Dose Expansion Group 4 - 21-day treatment cycle - Tumor TBD
Dose Expansion of HWK-007, a PTK7-directed ADC.
Drug: HWK-007
HWK-007 is a PTK7- targeted ADC being developed for the treatment of solid tumors.
Other Names:
  • HWK-007 anti-PTK7 targeted ADC

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
From Cycle 1, Day 1 until Cycle 1, Day 21 (21-day cycles)
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).
From Cycle 1, Day 1 to Cycle 1, Day 21 (21-day cycles) until the MTD is reached.
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).
From Cycle 1, Day 1 to Cycle 1, Day 21 (21-day cycles) until MTD is identified.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Cycle 1 and Cycle 4 (21-day cycles)
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.
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.
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
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.
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
From Cycle 1, Day 1 (21-day cycles) until death or 24 months, whichever comes first.
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.
At Cycle 1 and Cycle 4 - (21-day cycles)
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.
At Cycle 1 and Cycle 4 (21-day cycles).
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.
Cycle 1 and Cycle 4 - (21-day cycles)
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
Cycle 1 and Cycle 4 (21-day cycles)
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.
Cycle 1 and Cycle 4 (21-day cycles)
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.
From Cycle 1, Day 1 (21-day cycles) until disease progression or 24 months, whichever comes first.
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.
From Cycle 1, Day 1 (21-day cycles) infusion to End of Study (up to 24 months)
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.
From Cycle 1, Day 1 (21-day cycles) until disease progression or 24 months, whichever comes first.
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.
From Cycle 1, Day 1 (21-day cycles) until End of Study or 24 months, whichever comes first.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Whitehawk Therapeutics, Inc.

Investigators

  • Study Director: Margaret C Dugan, MD, Whitehawk Therapeutics
  • Study Director: Edward C Spindler, BS, MBA, Whitehawk Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 19, 2025

Primary Completion (Estimated)

October 1, 2028

Study Completion (Estimated)

December 1, 2028

Study Registration Dates

First Submitted

February 11, 2026

First Submitted That Met QC Criteria

February 24, 2026

First Posted (Actual)

March 3, 2026

Study Record Updates

Last Update Posted (Actual)

March 27, 2026

Last Update Submitted That Met QC Criteria

March 26, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HWK-007-101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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