A Study of CHS-1000 in Participants With Advanced or Metastatic Solid Tumors

Официальное название

A Phase 1, Multicenter, Open-Label Study of CHS-1000 as a Single Agent and in Combination With Toripalimab-tpzi in Participants With Advanced or Metastatic Solid Tumors

Обзор

The primary purpose of this trial is to assess the tolerability and safety of CHS-1000 alone and in combination with toripalimab-tpzi in participants with advanced solid tumors.

Вмешательства

• Биопрепарат CHS-1000
  Specified dose on specified days
• Биопрепарат Toripalimab
  Specified dose on specified days

Первичные конечные точки

• Number of Participants with Treatment-Emergent Adverse Events (TEAEs) [Срок оценки: Up to approximately 27 months]

Вторичные конечные точки (10)

• Maximum Observed Concentration (Cmax) [Срок оценки: Up to approximately 27 months]
• Area Under the Concentration-time Curve (AUC) [Срок оценки: Up to approximately 27 months]
• Terminal Half-life (t1/2) [Срок оценки: Up to approximately 27 months]
• Number of Participants with Antidrug Antibodies [Срок оценки: Up to approximately 27 months]
• Investigator-assessed Objective Response Rate (ORR) [Срок оценки: Up to approximately 27 months]
• Duration of Response (DoR) [Срок оценки: Up to approximately 27 months]
• Disease Control Rate (DCR) [Срок оценки: Up to approximately 27 months]
• Time to Response (TTP) [Срок оценки: Up to approximately 27 months]
• Progression-free Survival (PFS) [Срок оценки: Up to approximately 27 months]
• Landmark PFS Rate [Срок оценки: Month 6, Month 12]

Критерии участия

Критерии включения

• Histopathologically or cytologically confirmed diagnosis of advanced or metastatic unresectable solid tumors (excluding glioblastoma multiforme (GBM)) by tissue biopsy or archival tumor specimen. Unresectable tumors are defined as tumors with lesions in which clear surgical excision margins cannot be obtained, in close proximity to major blood vessels, not with oligometastatic and with advanced organ and lymph node (LN) involvement, and not leading to significant functional compromise as determined by surgical consult or Tumor Board.
• Participants must have been previously treated or be ineligible for, or intolerant of, available approved standard therapies known to confer clinical benefit (including immunotherapy), or for whom no effective standard therapy exists.
• At least 1 measurable lesion based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as determined by the investigator.

Критерии исключения

• Concurrent enrollment in another clinical study or participation in another clinical study within 28 days prior to the 1st dose of CHS-1000, except for observational (noninterventional) studies or the follow-up period of an interventional study.
• Current or prior use of systemic anticancer treatment, including but not limited to chemotherapy, immunotherapy, biologic treatment, hormone therapy, and targeted therapy, if within 8 weeks or 5 half-lives (whichever is shorter) for biologic therapies, or if within 28 days for most other anticancer therapies, prior to the 1st dose of CHS-1000.
• Concurrent or prior radiotherapy within 28 days prior to the 1st dose of CHS-1000 or unresolved treatment-related radiation toxicity. Limited local radiotherapy for palliative intent (eg, to a single site of metastatic disease) is permitted within 28 days prior to the 1st dose of CHS-1000 provided that the participant has no evidence of or has recovered from any treatment-related radiation toxicity.

Note: Other protocol-defined inclusion and exclusion criteria may apply.

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

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06389526 · CHS-1000-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗