Recruiting
Phase 1

HWK-007

Sponsor:

Whitehawk Therapeutics, Inc.

Code:

NCT07444814

Conditions

Endometrial Cancer

Ovarian Cancer

Ovarian Cancer Metastatic

Ovarian Cancer Metastatic Recurrent

Non-squamous EGFR Wt NSCLC

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

HWK-007

Study Details

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.

Conditions

Endometrial Cancer

Ovarian Cancer

Ovarian Cancer Metastatic

Ovarian Cancer Metastatic Recurrent

Non-squamous EGFR Wt NSCLC

Study ID

NCT07444814

Start date

Dec 19, 2025

Status verified date

Aug, 2026

Completion date

Dec, 2028

Anticipated

Primary completion date

Oct, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

226 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Dose Escalation - 21 Day treatment cycle

Escalating doses of HWK-007 administered intravenously (IV)

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

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

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

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

Expanded enrolment at third selected dose in Tumor - TBD

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

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

Interventions

HWK-007

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

Primary outcome measure

  • Determine Maximum Tolerated Dose (MTD) [ Time Frame: 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 Recommended Dose for Expansion (RDE) [ Time Frame: From Cycle 1, Day 1 to Cycle 1, Day 21 (21-day cycles) until MTD is identified. ]

Central Contacts and Locations

Central contacts

Clinical Trial Manager Lead

866-742-9495WHWK-Clinical-Trials@whitehawktx.com

Central email mailbox - Whitehawk Therapeutics

WHWK-Clinical-Trials@whitehawktx.com

Locations

University of Arkansas

Recruiting

Little Rock, Arkansas, United States, 72205-7199

Contacts

Michael Birrer, MD

MJbirrer@uams.edu

Principal Investigator:

Michael Birrer, MD

St. Francis Medical Center (OSF Healthcare)

Recruiting

Peoria, Illinois, United States, 61637

Contacts

Michelle C Rowland, MD

309-308-3350michelle.rowland@osfhealthcare.org

Principal Investigator:

Michelle Rowland, MD

START - Midwest

Recruiting

Grand Rapids, Michigan, United States, 49546

Contacts

Manish Sharma, MD

616-954-5554manish.sharma@startresearch.com

Principal Investigator:

Manish Sharma

Hackensack University Medical Center - John Theurer Cancer Center

Recruiting

Hackensack, New Jersey, United States, 07601

Contacts

Oncology Clinical Research Referral Office

551-996-1777oncologyresearchreferral@hmhn.org

Principal Investigator:

Miguel Gonzalez, MD

Roswell Park Comprehensive Care Center

Recruiting

Buffalo, New York, United States, 14263

Contacts

Bailey Fitzgerald, MD

716-845-2300bailey.fitzgerald@roswellpark.org

Principal Investigator:

Bailey Fitzgerald, MD

University Hospital - Cleveland Medical Center

Recruiting

Cleveland, Ohio, United States, 44106

Contacts

Matthew C Mirsky, MD

301-980-8969Matthew.Mirsky2@UHhospitals.org

Principal Investigator:

Matthew MIrsky, MD

NEXT Oncology - Austin

Recruiting

Austin, Texas, United States, 78758

Contacts

Sheena Sahota, MD

737-610-5200ssahota@nextoncology.com

NEXT - Oncology - Houston

Recruiting

Houston, Texas, United States, 77054

Contacts

Jennifer Segar, MD

832-384-7900jsegar@nextoncology.com

Principal Investigator:

Jennifer Segar, MD

START - San Antonio

Recruiting

San Antonio, Texas, United States, 78229

Contacts

Drew Rasco, MD

210-593-5258drew.rasco@startresearch.com

NEXT Oncology - Virginia Cancer Specialists

Recruiting

Fairfax, Virginia, United States, 22031

Contacts

Alexander Spira, MD, PhD

571-350-8400aspira@nextoncology.com

Principal Investigator:

Alexander Spira, MD, PhD

More Information

Sponsor

Whitehawk Therapeutics, Inc.

Last update posted

Aug 5, 2026

Last verified

Aug, 2026

Keywords

  • PTK7
  • Ovarian cancer
  • Endometrial cancer
  • NSCLC
  • Lung cancer
  • Chemotherapy
  • ADC
  • Antibody-Drug-Conjugate
  • Solid tumor
  • Phase 1
  • Ovarian neoplasms
  • Endometrial neoplasms
  • Carcinoma, Non Small Cell Lung
  • Lung neoplasms
  • Gynecologic cancer
  • EGFR Wt NSCLC
  • Platinum Resistant Ovarian Cancer
  • DNA Topoisomerase I

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-10. This information was provided to ClinicalTrials.gov by Whitehawk Therapeutics, Inc. on 2026-08-05. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.