ARC101 in Advanced Solid Tumors

Официальное название

A Phase 1 Study of ARC101 in Advanced Solid Tumors

Обзор

This first-in-human study will evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of ARC101 in patients with advanced cancer.

Вмешательства

• Препарат ARC101
  ARC101 will be administered according to an assigned dose schedule.

Первичные конечные точки

• Frequency and type of dose-limiting toxicities. [Срок оценки: Day 1-Day 21 of the first treatment cycle]
• Occurrence and severity of adverse events, serious adverse events and laboratory values. [Срок оценки: Day 1 to 100 days after the last dose of study drug.]

Вторичные конечные точки (8)

• PK Assessment: Cmax of ARC101 [Срок оценки: During the intervention/study therapy administration, approximately 1 year on average.]
• PK Assessment: Cmin of ARC101 [Срок оценки: During the intervention/study therapy administration, approximately 1 year on average.]
• PK Assessment: Tmax of ARC101 [Срок оценки: During the intervention/study therapy administration, approximately 1 year on average.]
• PK Assessment: AUC of ARC101 [Срок оценки: During the intervention/study therapy administration, approximately 1 year on average.]
• Overall Response Rate [Срок оценки: During the intervention/study therapy administration, approximately 1 year on average.]
• Duration of Response [Срок оценки: During the intervention/study therapy administration, approximately 1 year on average.]
• Progression-Free Survival [Срок оценки: During the intervention/study therapy administration, approximately 1 year on average.]
• Number of anti-drug antibody (ADA) Positive Participants [Срок оценки: During the intervention/study therapy administration, approximately 1 year on average.]

Критерии участия

Критерии включения

• Locally advanced or metastatic solid tumor ovarian, testicular or other Claudin 6+ cancers
• Measurable or evaluable disease, per RECIST v1.1
• Eastern Cooperative Oncology Group (ECOG) performance status 0-1
• Adequate organ function

Критерии исключения

• Active CNS involvement
• Malignancy diagnosis other than the disease under study within 2 years prior to the first dose of study drug.
• Presence of uncontrolled ascites
• Toxicity related to prior anticancer therapy that has not returned to Grade ≤1 or baseline levels
• Clinically significant pulmonary compromise
• Active autoimmune disease within 12 months prior to first dose of study drug.
• Female participant who is pregnant, breastfeeding, or plans to become pregnant or male participant who plans to father a child either while enrolled or within 90 days after the final administration of study drug.

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 · 3 центра

• Massachusetts General Hospital — Boston
• START Midwest — Grand Rapids
• START San Antonio, LLC. — San Antonio

Австралия · 3 центра

• Sunshine Coast University Private Hospital — Birtinya
• Cancer Research SA — Adelaide
• Cabrini Health Research — Malvern

Канада · 3 центра

• BC Cancer Research Centre — Vancouver
• The Princess Margaret Cancer Centre — Toronto
• McGill University Health Centre — Montreal

Израиль · 3 центра

• Rambam Medical Center — Haifa
• Sheba Medical Center — Ramat Gan
• Sourasky Medical Center — Tel Aviv

Идентификаторы

NCT: NCT06672185 · ARC101-P1-101

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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