NCT07444814

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
226

participants targeted

Target at P75+ for phase_1

Timeline
30mo left

Started Dec 2025

Typical duration for phase_1

Geographic Reach
1 country

12 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 Progress17%
Dec 2025Dec 2028

Study Start

First participant enrolled

December 19, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 11, 2026

Completed
20 days until next milestone

First Posted

Study publicly available on registry

March 3, 2026

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2028

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

March 27, 2026

Status Verified

March 1, 2026

Enrollment Period

2.8 years

First QC Date

February 11, 2026

Last Update Submit

March 26, 2026

Conditions

Endometrial CancerOvarian CancerOvarian Cancer MetastaticOvarian Cancer Metastatic RecurrentPlatinum Resistant Ovarian CancerPROCNon-squamous EGFR Wt NSCLC

Keywords

PTK7Ovarian cancerEndometrial cancerNSCLCLung cancerChemotherapyADCAntibody-Drug-ConjugateSolid tumorPhase 1Ovarian neoplasmsEndometrial neoplasmsCarcinoma, Non Small Cell LungLung neoplasmsGynecologic cancerEGFR Wt NSCLCPlatinum Resistant Ovarian CancerDNA Topoisomerase I

Outcome Measures

Primary Outcomes (3)

  • Determine Maximum Tolerated Dose (MTD)

    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)

    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)

    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 Outcomes (13)

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

    Cycle 1 and Cycle 4 (21-day cycles)

  • Assess ADA (Anti drug antibody) against HWK-007

    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)

    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).

    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)

    At Cycle 1 and Cycle 4 - (21-day cycles)

  • +8 more secondary outcomes

Study Arms (5)

Dose Escalation - 21 Day treatment cycle

EXPERIMENTAL

Escalating doses of HWK-007 administered intravenously (IV)

Drug: HWK-007

Dose Expansion Group 1- 21-day treatment cycle - non-squamous EGFR-WT NSCLC

EXPERIMENTAL

Expanded enrolment at selected dose of HWK-007 in NSCLC.

Drug: HWK-007

Dose Expansion Group 2 - 21-day treatment cycle - Tumor TBD

EXPERIMENTAL

Expanded enrolment at second selected dose of HWK-007 administered intravenously (IV) in Tumor - TBD

Drug: HWK-007

Dose Expansion Group 3 - 21-day treatment cycle - Tumor TBD

EXPERIMENTAL

Expanded enrolment at third selected dose in Tumor - TBD

Drug: HWK-007

Dose Expansion Group 4 - 21-day treatment cycle - Tumor TBD

EXPERIMENTAL

Dose Expansion of HWK-007, a PTK7-directed ADC.

Drug: HWK-007

Interventions

HWK-007DRUG

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

Also known as: HWK-007 anti-PTK7 targeted ADC
Dose Escalation - 21 Day treatment cycleDose Expansion Group 1- 21-day treatment cycle - non-squamous EGFR-WT NSCLCDose Expansion Group 2 - 21-day treatment cycle - Tumor TBDDose Expansion Group 3 - 21-day treatment cycle - Tumor TBDDose Expansion Group 4 - 21-day treatment cycle - Tumor TBD

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

University of Arkansas

Little Rock, Arkansas, 72205-7199, United States

NOT YET RECRUITING

UCLA - Hematology/Oncology Clinical Research Unit

Los Angeles, California, 90095, United States

NOT YET RECRUITING

St. Francis Medical Center (OSF Healthcare)

Peoria, Illinois, 61637, United States

NOT YET RECRUITING

START - Midwest

Grand Rapids, Michigan, 49546, United States

RECRUITING

Hackensack University Medical Center - John Theurer Cancer Center

Hackensack, New Jersey, 07601, United States

NOT YET RECRUITING

Roswell Park Comprehensive Care Center

Buffalo, New York, 14263, United States

NOT YET RECRUITING

University Hospital - Cleveland Medical Center

Cleveland, Ohio, 44106, United States

NOT YET RECRUITING

NEXT Oncology - Austin

Austin, Texas, 78758, United States

RECRUITING

NEXT - Oncology - Houston

Houston, Texas, 77054, United States

RECRUITING

START - San Antonio

San Antonio, Texas, 78229, United States

RECRUITING

NEXT Oncology - Virginia Cancer Specialists

Fairfax, Virginia, 22031, United States

RECRUITING

Fred Hutchinson Cancer Center

Seattle, Washington, 98109, United States

NOT YET RECRUITING

MeSH Terms

Conditions

Endometrial NeoplasmsOvarian NeoplasmsLung NeoplasmsCarcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesEndocrine Gland NeoplasmsOvarian DiseasesAdnexal DiseasesEndocrine System DiseasesGonadal DisordersRespiratory Tract NeoplasmsThoracic NeoplasmsLung DiseasesRespiratory Tract DiseasesCarcinoma, BronchogenicBronchial Neoplasms

Study Officials

  • Margaret C Dugan, MD

    Whitehawk Therapeutics

    STUDY DIRECTOR

  • Edward C Spindler, BS, MBA

    Whitehawk Therapeutics

    STUDY DIRECTOR

Central Study Contacts

Clinical Trial Manager Lead

CONTACT

888-392-9025WHWK-Clinical-Trials@whitehawktx.com

Central email mailbox - Whitehawk Therapeutics

CONTACT

WHWK-Clinical-Trials@whitehawktx.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Model Details: The study employs a sequential dose escalation and dose expansion design without a control group
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 11, 2026

First Posted

March 3, 2026

Study Start

December 19, 2025

Primary Completion (Estimated)

October 1, 2028

Study Completion (Estimated)

December 1, 2028

Last Updated

March 27, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share
Shared Documents
CSR

Locations

US(12)