226 Participants NeededMy employer runs this trial

HWK-007 for Ovarian Cancer

Recruiting at 11 trial locations
CT
Ce
Overseen ByCentral email mailbox - Whitehawk Therapeutics
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Whitehawk Therapeutics, Inc.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called HWK-007 for individuals with certain advanced or metastatic solid tumors. The main focus is on the effectiveness and safety of HWK-007 at different doses. The study targets individuals with cancers such as non-squamous EGFR-WT NSCLC (a type of lung cancer), endometrial carcinoma, and ovarian cancer resistant to platinum-based treatments. Ideal candidates are those who have lived with any of these cancers and have not responded well to standard treatments. As a Phase 1 trial, the research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that HWK-007 is likely to be safe for humans?

Research has shown that HWK-007 is currently under evaluation for safety and effectiveness in treating various types of cancer. This marks the first human trial of HWK-007, so no prior safety data exists for people. The study is in Phase 1, focusing primarily on safety and determining the correct dosage.

Before human testing, lab and animal studies demonstrated that HWK-007 could significantly reduce tumors. Although these results are promising, they do not guarantee similar effects in humans.

As an early-stage trial, participants might experience side effects as researchers assess the drug's tolerance. The study is designed to closely monitor these effects and adjust doses as necessary.12345

Why do researchers think this study treatment might be promising for ovarian cancer?

Most treatments for ovarian cancer, like chemotherapy, target rapidly dividing cells. But HWK-007 works differently, as it is a PTK7-directed antibody-drug conjugate (ADC). This means it specifically targets the PTK7 protein, which is often found on cancer cells, delivering the drug directly to the tumor and potentially reducing damage to healthy cells. Researchers are excited about HWK-007 because this targeted approach could lead to more effective treatments with fewer side effects compared to traditional therapies.

What evidence suggests that HWK-007 might be an effective treatment for ovarian cancer?

Research has shown that HWK-007 targets a protein called PTK7, often found in large amounts in some cancers, such as ovarian cancer. Studies indicate that PTK7 is linked to cancer spreading and treatment resistance. HWK-007 is designed to attach to PTK7 and deliver cancer-fighting drugs directly to the tumor. Early tests in the lab and in animals suggested that HWK-007 could outperform previous treatments for ovarian cancer. Its effectiveness stems from targeting PTK7, present in about 70% of certain tumors. Participants in this trial will receive HWK-007 in different dosing regimens to evaluate its safety and effectiveness.13678

Who Is on the Research Team?

AU

Allison Upalawanna

Principal Investigator

Whitehawk Therapeutics

MC

Margaret C Dugan, MD

Principal Investigator

Whitehawk Therapeutics

Are You a Good Fit for This Trial?

This trial is for adults with advanced or metastatic solid tumors (like certain lung, ovarian, endometrial, or prostate cancers) that have a marker called PTK7. Participants must have specific types of these cancers and may have already tried other treatments.

Inclusion Criteria

My lung cancer is non-squamous and does not have EGFR mutations.
I have endometrial cancer.
My ovarian cancer did not respond to platinum-based chemotherapy.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive escalating doses of HWK-007 administered intravenously every 3 weeks

21-day cycles
1 visit every 3 weeks

Dose Expansion

Expanded enrolment at selected doses of HWK-007 in various tumor types

21-day cycles
1 visit every 3 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

up to 24 months

What Are the Treatments Tested in This Trial?

Interventions

  • HWK-007

Trial Overview

The study is testing HWK-007, a new drug designed to target cancer cells with the PTK7 marker. It's an early-phase trial where all participants receive HWK-007 at different dose levels to find the safest and most effective dose.

How Is the Trial Designed?

5

Treatment groups

Experimental Treatment

Group I: Dose Expansion Group 4 - 21-day treatment cycle - Tumor TBDExperimental Treatment1 Intervention
Group II: Dose Expansion Group 3 - 21-day treatment cycle - Tumor TBDExperimental Treatment1 Intervention
Group III: Dose Expansion Group 2 - 21-day treatment cycle - Tumor TBDExperimental Treatment1 Intervention
Group IV: Dose Expansion Group 1- 21-day treatment cycle - non-squamous EGFR-WT NSCLCExperimental Treatment1 Intervention
Group V: Dose Escalation - 21 Day treatment cycleExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Whitehawk Therapeutics, Inc.

Lead Sponsor

Citations

Corporate Presentation

In vitro and in vivo data suggest improved efficacy vs 1st gen predecessor in ovarian cancer. Phase 1 planned in ovarian cancer – potential to expand into ...

NCT07444814 | Study Evaluating the Safety and Efficacy of ...

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 ...

Preclinical assessment of HWK-007, a next-generation, PTK7 ...

Overexpression of PTK7 contributes to metastasis, chemoresistance, and poor clinical outcomes in multiple tumor types. PTK7 is overexpressed in ...

Whitehawk Therapeutics Presents Comprehensive ...

HWK-007 targets PTK7, the third most highly expressed tumor marker among clinically validated and emerging ADC targets, present in ~70% of ...

5.

whitehawktx.com

whitehawktx.com/pipeline/

Pipeline

HWK-007 is being evaluated in a Phase 1 trial that will initially evaluate activity in lung and ovarian cancers, two PTK7-expressing tumor types with ...

HWK-007, a PTK7-directed Antibody Drug Conjugate in ...

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 ...

HWK-007 for Ovarian Cancer

This Phase 1 medical study run by Whitehawk Therapeutics, Inc. is evaluating whether HWK-007 will have tolerable side effects & efficacy for ...

Whitehawk Therapeutics Reports First Quarter 2026 ...

HWK‑007 is being evaluated in patients with non-squamous, EGFR wild ... ovarian cancer; and endometrial cancer (NCT07444814). HWK‑016 ...