HWK-007 for Ovarian Cancer

Recruiting at 11 trial locations

Overseen By Central email mailbox - Whitehawk Therapeutics

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Whitehawk Therapeutics, Inc.

Disqualifiers: CNS metastases, Carcinomatous meningitis, Infections, Cardiovascular disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

226 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

Margaret C Dugan, MD

Principal Investigator

Whitehawk Therapeutics

Edward C Spindler, BS, MBA

Principal Investigator

Whitehawk Therapeutics

Are You a Good Fit for This Trial?

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.

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

How Is the Trial Designed?

Group I: Dose Expansion Group 4 - 21-day treatment cycle - Tumor TBD Experimental Treatment 1 Intervention

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

Group II: Dose Expansion Group 3 - 21-day treatment cycle - Tumor TBD Experimental Treatment 1 Intervention

Expanded enrolment at third selected dose in Tumor - TBD

Group III: Dose Expansion Group 2 - 21-day treatment cycle - Tumor TBD Experimental Treatment 1 Intervention

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

Group IV: Dose Expansion Group 1- 21-day treatment cycle - non-squamous EGFR-WT NSCLC Experimental Treatment 1 Intervention

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

Group V: Dose Escalation - 21 Day treatment cycle Experimental Treatment 1 Intervention

Escalating doses of HWK-007 administered intravenously (IV)

Who Is Running the Clinical Trial?

Whitehawk Therapeutics, Inc.

Lead Sponsor