Study Evaluating the Safety and Efficacy of HWK-007, a PTK7-directed Antibody Drug Conjugate in Participants With Advanced Solid Tumors
Purpose
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
- Platinum Resistant Ovarian Cancer
- PROC
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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
- 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
- Phase
- Phase 1
- Study Type
- Interventional
- Allocation
- Non-Randomized
- Intervention Model
- Sequential Assignment
- Intervention Model Description
- The study employs a sequential dose escalation and dose expansion design without a control group
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
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. |
|
Recruiting Locations
Grand Rapids, Michigan 49546
Austin, Texas 78758
Houston, Texas 77054
San Antonio, Texas 78229
Fairfax, Virginia 22031
More Details
- Status
- Recruiting
- Sponsor
- Whitehawk Therapeutics, Inc.
Detailed Description
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).