A Study of ADRX-0405 in Subjects With Select Advanced Solid Tumors

Официальное название

A Phase 1a/b Study of ADRX-0405 in Subjects With Select Advanced Solid Tumors

Обзор

The primary purpose of this study is to assess the safety, tolerability, and pharmacokinetics, and to identify the optimal dose of ADRX-0405 in patients with select advanced solid tumors.

Подробное описание

This is a 2-part study. The Phase 1a will consist of a dose escalation of ADRX-0405 to evaluate initial safety and tolerability in patients with select advanced solid tumors \[including metastatic castration resistant prostate cancer (mCRPC), gastric cancer (GC), and non-small cell lung cancer (NSCLC)\], and to identify the recommended dose to be used in the Phase 1b. The Phase 1b will further evaluate the safety and tolerability, as well as preliminary efficacy, and identify the optimal dose of ADRX-0405 in subjects with previously treated metastatic castration resistant prostate cancer (mCRPC).

Вмешательства

• Препарат ADRX-0405
  Antibody Drug Conjugate targeting STEAP1

Первичные конечные точки

• Incidence of adverse events [Срок оценки: Until study completion (estimated 2 years)]

Вторичные конечные точки (12)

• Measurement of End of Infusion or observed maximum blood concentration (Ceoi orCmax) of ADRX-0405 [Срок оценки: Until study completion (estimated 2 years)]
• Measurement of trough concentration (Ctrough) of ADRX-0405 [Срок оценки: Until study completion (estimated 2 years)]
• Measurement of area under the blood concentration-time curve (AUC) of ADRX-0405 [Срок оценки: Until study completion (estimated 2 years)]
• Measurement of partial area under the concentration-time curve after first dose (AUC0-21) of ADRX-0405 and as appropriate [Срок оценки: Until study completion (estimated 2 years)]
• Measurement of terminal or apparent terminal half-life (t1/2) of ADRX-0405 [Срок оценки: Until study completion (estimated 2 years)]
• Measurement of systemic clearance (CL) and volume of distribution at steady state (Vss) as appropriate of ADRX-0405 [Срок оценки: Until study completion (estimated 2 years)]
• Incidence of anti-drug antibody (ADA) to ADRX-0405 [Срок оценки: Until study completion (estimated 2 years)]
• Measurement of objective response rate (ORR) per RECIST 1.1 [Срок оценки: Until study completion (estimated 2 years)]
• ORR per Prostate Cancer Working Group 3 (PCWG3) [Срок оценки: Until study completion (estimated 2 years)]
• Measurement of duration of response (DOR) [Срок оценки: Until study completion (estimated 2 years)]
• Measurement of disease control rate (DCR) [Срок оценки: Until study completion (estimated 2 years)]
• Measurement of progression free survival (PFS) [Срок оценки: Until study completion (estimated 2 years)]

Критерии участия

Критерии включения

• Phase 1a Dose Escalation: Subjects with histologically confirmed select advanced solid tumors, including metastatic castration resistant prostate cancer (mCRPC), gastric cancer (GC), and non-small cell lung cancer (NSCLC).
• Phase 1b Dose Expansion: Subjects with histologically confirmed prostate adenocarcinoma that is confirmed to be castration resistant (i.e., serum testosterone < 50 ng/dL \[< 2.0 nM\]) and that is intolerant/resistant to standard of care (SOC) therapies.
• Measurable disease according to RECIST version 1.1 or evaluable disease per PCWG3 for subjects with prostate cancer
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 in 1a; 0-2 in 1b
• Adequate hematologic, liver, and renal function

Критерии исключения

• Active and uncontrolled central nervous system metastases
• Significant cardiovascular disease
• History of another malignancy other than the one for which the subject is being treated on this study within 3 years
• Receipt of any anticancer or investigational therapy within: 5 elimination half-lives or 14 days (whichever is less); 4 weeks for any therapeutic radiopharmaceutical for prostate cancer
• History of (non-infectious) ILD/pneumonitis that required steroids within 2 years of study enrollment, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening.
• Receiving systemic antimicrobial treatment for active infection; routine antimicrobial prophylaxis is permitted

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 · 8 центров

• City of Hope — Duarte
• UCLA — Santa Monica
• START Midwest — Grand Rapids
• University of Minnesota Masonic Cancer Center — Minneapolis
• NEXT Austin — Austin
• The University of Texas MD Anderson Cancer Center — Houston
• START Mountain Region — West Valley City
• NEXT Virginia — Fairfax

Идентификаторы

NCT: NCT06710379 · ADRX-0405-001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗