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

Part of paid clinical trials in Little Rock, Arkansas.

Sponsor
Whitehawk Therapeutics, Inc.
Study ID
NCT07444814
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Dec 19, 2025
Status verified
Mar 2026
Primary completion
Oct 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
226 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

Determine Maximum Tolerated Dose (MTD) [ Time Frame: From Cycle 1, Day 1 until Cycle 1, Day 21 (21-day cycles) ]

Central Contacts

Locations (12)

FacilityCityStateZIPSite coordinators
University of ArkansasLittle RockArkansas72205-7199
Michael Birrer, MD
[email protected]
Michael Birrer, MD (PRINCIPAL_INVESTIGATOR)
UCLA - Hematology/Oncology Clinical Research UnitLos AngelesCalifornia90095
Aaron Lisberg, MD
[email protected]
310-352-8252
Aaron Lisberg, MD (PRINCIPAL_INVESTIGATOR)
St. Francis Medical Center (OSF Healthcare)PeoriaIllinois61637
Michelle C Rowland, MD
[email protected]
309-308-3350
Michelle Rowland, MD (PRINCIPAL_INVESTIGATOR)
START - MidwestGrand RapidsMichigan49546
Manish Sharma, MD
[email protected]
616-954-5554
Manish Sharma (PRINCIPAL_INVESTIGATOR)
Hackensack University Medical Center - John Theurer Cancer CenterHackensackNew Jersey07601
Oncology Clinical Research Referral Office
[email protected]
551-996-1777
Miguel Gonzalez, MD (PRINCIPAL_INVESTIGATOR)
Roswell Park Comprehensive Care CenterBuffaloNew York14263
Bailey Fitzgerald, MD
[email protected]
716-845-2300
Bailey Fitzgerald, MD (PRINCIPAL_INVESTIGATOR)
University Hospital - Cleveland Medical CenterClevelandOhio44106
Matthew C Mirsky, MD
[email protected]
301-980-8969
C
Matthew MIrsky, MD (PRINCIPAL_INVESTIGATOR)
NEXT Oncology - AustinAustinTexas78758
Sheena Sahota, MD
[email protected]
737-610-5200
NEXT - Oncology - HoustonHoustonTexas77054
Jennifer Segar, MD
[email protected]
832-384-7900
Jennifer Segar, MD (PRINCIPAL_INVESTIGATOR)
START - San AntonioSan AntonioTexas78229
Drew Rasco, MD
[email protected]
210-593-5258
NEXT Oncology - Virginia Cancer SpecialistsFairfaxVirginia22031
Alexander Spira, MD, PhD
[email protected]
571-350-8400
Alexander Spira, MD, PhD (PRINCIPAL_INVESTIGATOR)
Fred Hutchinson Cancer CenterSeattleWashington98109
Lei C Deng, MD
[email protected]
206-606-4801
C
Lei Deng, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Little Rock, AR

By condition
Endometrial cancerOvarian cancer
By specialty
OncologyGynecologic oncologyWomen's health
By research site
University of Arkansas· Little Rock, ARUCLA - Hematology/Oncology Clinical Research Unit· Los Angeles, CASt. Francis Medical Center (OSF Healthcare)· Peoria, ILSTART - Midwest· Grand Rapids, MIHackensack University Medical Center - John Theurer Cancer Center· Hackensack, NJRoswell Park Comprehensive Care Center· Buffalo, NY

Related Studies