Study Evaluating the Safety and Efficacy of HWK-007, a PTK7-directed Antibody Drug Conjugate in Participants With Advanced Solid Tumors
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: HWK-007.
- Кому может быть актуально
- Состояния в реестре: Endometrial Cancer, Ovarian Cancer, Ovarian Cancer Metastatic, Ovarian Cancer Metastatic Recurrent. Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- США
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
A Phase 1 First-in-Human Study of PTK7-Directed Antibody Drug Conjugate HWK-007 in Participants With Advanced Solid Tumors
Обзор
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.
Подробное описание
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).
Вмешательства
- Препарат HWK-007
HWK-007 is a PTK7- targeted ADC being developed for the treatment of solid tumors.
Первичные конечные точки
- Determine Maximum Tolerated Dose (MTD) [Срок оценки: From Cycle 1, Day 1 until Cycle 1, Day 21 (21-day cycles)]
- Determine Maximum Administered Dose (MAD) [Срок оценки: 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) [Срок оценки: From Cycle 1, Day 1 to Cycle 1, Day 21 (21-day cycles) until MTD is identified.]
Вторичные конечные точки (12)
- Characterize the Volume of Distribution (Vd) of HWK-007 (ADC, total antibody, CPT116, and CPT119) [Срок оценки: Cycle 1 and Cycle 4 (21-day cycles)]
- Assess ADA (Anti drug antibody) against HWK-007 [Срок оценки: 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) [Срок оценки: 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). [Срок оценки: 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) [Срок оценки: At Cycle 1 and Cycle 4 - (21-day cycles)]
- Time to Maximum Concentration (Tmax) of HWK-007 (ADC, total antibody, CPT116, and CPT119) [Срок оценки: 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) [Срок оценки: Cycle 1 and Cycle 4 - (21-day cycles)]
- T1/2 - Half-life of HWK-007 (ADC, total antibody, CPT116, and CPT119) [Срок оценки: Cycle 1 and Cycle 4 (21-day cycles)]
- Clearance (CL) [Срок оценки: Cycle 1 and Cycle 4 (21-day cycles)]
- Evaluate the Duration of Response (DoR) to HWK-007 [Срок оценки: From Cycle 1, Day 1 (21-day cycles) until disease progression or 24 months, whichever comes first.]
- Evaluate Progression-free Survival (PFS) [Срок оценки: From Cycle 1, Day 1 (21-day cycles) infusion to End of Study (up to 24 months)]
- Evaluate Disease control Rate (DCR) [Срок оценки: From Cycle 1, Day 1 (21-day cycles) until disease progression or 24 months, whichever comes first.]
Критерии участия
Критерии включения
Have one of the following solid tumor cancers:
- Monotherapy escalation and backfill cohorts:
- non-squamous EGFR-Wt NSCLC
- Endometrial carcinoma
- Platinum Resistant Ovarian Cancer
- Monotherapy expansion cohorts:
- Non-squamous EGFR-Wt NSCLC
- Additional tumor indications to be defined in a future amendment
Критерии исключения
- Individual with known or suspected uncontrolled central nervous system (CNS) metastases
- Individual with history of carcinomatous meningitis
- Individual with active uncontrolled systemic bacterial, viral, fungal, or parasitic infection
- Individual with evidence of corneal keratopathy or history of cornea transplant
- Any serious unresolved toxicities from prior therapy
- Significant cardiovascular disease
- Prolongation of QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥ 470 milliseconds (ms)
- History of pneumonitis/interstitial lung disease
- Individuals who are pregnant, breastfeeding or plan to breastfeed during study or within 30 days of last dose of study intervention
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Нерандомизированное
- Модель
- Последовательный дизайн
- Маскирование
- Открытое
- Основная цель
- Лечение
Центры проведения
США · 12 центров
- University of Arkansas — Little Rock
- UCLA - Hematology/Oncology Clinical Research Unit — Los Angeles
- St. Francis Medical Center (OSF Healthcare) — Peoria
- START - Midwest — Grand Rapids
- Hackensack University Medical Center - John Theurer Cancer Center — Hackensack
- Roswell Park Comprehensive Care Center — Buffalo
- University Hospital - Cleveland Medical Center — Cleveland
- NEXT Oncology - Austin — Austin
- … и ещё 4 центра
Идентификаторы
NCT: NCT07444814 · HWK-007-101