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.
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).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
226
HWK-007 is a PTK7- targeted ADC being developed for the treatment of solid tumors.
University of Arkansas
Little Rock, Arkansas, United States
NOT_YET_RECRUITINGUCLA - Hematology/Oncology Clinical Research Unit
Los Angeles, California, United States
NOT_YET_RECRUITINGSt. Francis Medical Center (OSF Healthcare)
Peoria, Illinois, United States
NOT_YET_RECRUITINGSTART - Midwest
Grand Rapids, Michigan, United States
RECRUITINGHackensack University Medical Center - John Theurer Cancer Center
Hackensack, New Jersey, United States
NOT_YET_RECRUITINGRoswell Park Comprehensive Care Center
Buffalo, New York, United States
NOT_YET_RECRUITINGUniversity Hospital - Cleveland Medical Center
Cleveland, Ohio, United States
NOT_YET_RECRUITINGNEXT Oncology - Austin
Austin, Texas, United States
RECRUITINGNEXT - Oncology - Houston
Houston, Texas, United States
RECRUITINGSTART - San Antonio
San Antonio, Texas, United States
RECRUITING...and 2 more locations
Determine Maximum Tolerated Dose (MTD)
Determine the highest dose of HWK-007 that can be administered without signs of toxicity measured at the end of Cycle 1 (21 day cycle) by: Incidence and severity of Adverse Events (AE). Incidence of Dose-Limiting Toxicities (DLT). Incidence of Serious Adverse Events (SAE).
Time frame: From Cycle 1, Day 1 until Cycle 1, Day 21 (21-day cycles)
Determine Maximum Administered Dose (MAD)
Determine the highest dose administered during the dose escalation part of the study measured at the end of Cycle 1 (21 day cycle) by: Incidence and severity of Adverse Events (AE). Incidence of Dose-Limiting Toxicities (DLT). Incidence of Serious Adverse Events (SAE).
Time frame: From Cycle 1, Day 1 to Cycle 1, Day 21 (21-day cycles) until the MTD is reached.
Determine the Recommended Dose for Expansion (RDE)
Determine the dose that will be recommended for further study within the tumor types studied in this clinical trial measured at the end of Cycle 1 (21 day cycle) by: Incidence and severity of Adverse Events (AE). Incidence of Dose-Limiting Toxicities (DLT). Incidence of Serious Adverse Events (SAE).
Time frame: From Cycle 1, Day 1 to Cycle 1, Day 21 (21-day cycles) until MTD is identified.
Characterize the Volume of Distribution (Vd) of HWK-007 (ADC, total antibody, CPT116, and CPT119)
Pharmacokinetic analysis of HWK-007 in human subjects
Time frame: Cycle 1 and Cycle 4 (21-day cycles)
Assess ADA (Anti drug antibody) against HWK-007
Using a blood test, determine the risk of developing anti-drug antibodies against HWK-007 following infusion in human patients.
Time frame: Every cycle from Cycle 1, Day 1 (21-day cycles) until 30 days past the last dose of study drug for up to 24 months.
Evaluate the Overall Response Rate (ORR)
Measure the response rate to the study drug by CT-scans evaluated using RECIST1.1
Time frame: From Cycle 1, Day 1 (21-day cycles), every 6-weeks for the first 4 assessments and then every 6 weeks for up to 24 months until disease progression or 24 months, whichever comes first.
Evaluate Overall Survival (OS).
Measure how long patient lives following treatment with HWK-007
Time frame: From Cycle 1, Day 1 (21-day cycles) until death or 24 months, whichever comes first.
Maximum Concentration - Cmax of HWK-007 (ADC, total antibody, CPT116, and CPT119)
Maximum amount of study drug and drug components in blood following infusion.
Time frame: At Cycle 1 and Cycle 4 - (21-day cycles)
Time to Maximum Concentration (Tmax) of HWK-007 (ADC, total antibody, CPT116, and CPT119)
Time to reach maximum concentration of drug and drug components in blood following infusion.
Time frame: At Cycle 1 and Cycle 4 (21-day cycles).
Area Under the Concentration Time Curve (AUC) for HWK-007 (ADC, total antibody, CPT116, and CPT119)
The total area under the concentration time curve of study drug and drug components following infusion.
Time frame: Cycle 1 and Cycle 4 - (21-day cycles)
T1/2 - Half-life of HWK-007 (ADC, total antibody, CPT116, and CPT119)
Time for 1/2 of the infused drug to be eliminated/metabolized
Time frame: Cycle 1 and Cycle 4 (21-day cycles)
Clearance (CL)
Measured rate at which HWK-007 is cleared from the blood following infusion.
Time frame: Cycle 1 and Cycle 4 (21-day cycles)
Evaluate the Duration of Response (DoR) to HWK-007
Measure the time from evidence of response by CT-scan until evidence of progression of cancer.
Time frame: From Cycle 1, Day 1 (21-day cycles) until disease progression or 24 months, whichever comes first.
Evaluate Progression-free Survival (PFS)
Measure the time from the first infusion of HWK-007 until evidence of cancer progression is detected.
Time frame: From Cycle 1, Day 1 (21-day cycles) infusion to End of Study (up to 24 months)
Evaluate Disease control Rate (DCR)
Measure the time from Cycle 1, Day 1 that cancer does not worsen by RECIST1.1 criteria.
Time frame: From Cycle 1, Day 1 (21-day cycles) until disease progression or 24 months, whichever comes first.
Time to Response (TTR)
Time from Cycle 1, Day 1 infusion of HWK-007 until evidence of response via CT scan according to RECIST1.1 criteria.
Time frame: From Cycle 1, Day 1 (21-day cycles) until End of Study or 24 months, whichever comes first.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.