Not currently recruiting at University of California Health

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

a study on Endometrial Cancer Ovarian Cancer Non-Small Cell Lung Cancer PROC Solid Tumor Lung Cancer Lung Tumor

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA
Dates
study started
study ends around
Principal Investigator
by Aaron Lisberg, MD (ucla)

Description

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.

Official Title

A Phase 1 First-in-Human Study of PTK7-Directed Antibody Drug Conjugate HWK-007 in Participants With Advanced Solid Tumors

Details

The study consists of 2 phases, Phase 1a (dose escalation) and Phase 1b (dose expansion). In Phase 1a, participants with non-squamous Endothelial Growth Factor Receptor Wild type (EGFR Wt) NSCLC, platinum resistant ovarian cancer (PROC), and endometrial cancer will be enrolled. In Phase 1b, non-squamous EGFR Wt NSCLC expansion cohort(s) will be opened, based on the safety, tolerability, PK, and preliminary antitumor data in Phase 1a.

In Phase 1a of the study, HWK-007 will initially be administered as an intravenous (IV) infusion every 3 weeks (Q3W).

Keywords

Endometrial Cancer, Ovarian Cancer, Ovarian Cancer Metastatic, Ovarian Cancer Metastatic Recurrent, Non-squamous EGFR Wt NSCLC, Platinum Resistant Ovarian Cancer, PROC, PTK7, 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, DNA Topoisomerase I, Non-Small-Cell Lung Carcinoma, HWK-007

Eligibility

You can join if…

Open to people ages 18 years and up

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

You CAN'T join if...

  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

Locations

  • UCLA - Hematology/Oncology Clinical Research Unit not yet accepting patients
    Los Angeles California 90095 United States
  • Fred Hutchinson Cancer Center not yet accepting patients
    Seattle Washington 98109 United States
  • START - San Antonio accepting new patients
    San Antonio Texas 78229 United States
  • NEXT Oncology - Austin accepting new patients
    Austin Texas 78758 United States

Lead Scientist at University of California Health

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
Whitehawk Therapeutics, Inc.
ID
NCT07444814
Phase
Phase 1 research study
Study Type
Interventional
Participants
Expecting 226 study participants
Last Updated