A Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of CD-001 in Patients With Advanced Solid Tumors

Официальное название

A Phase I, Multicenter, Open-Label, First-In-Human Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of CD 001 in Patients With Advanced Solid Tumors

Обзор

To assess the safety, tolerability, PK and preliminary efficacy of CD-001 in patients with advanced solid tumors. and to determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D).

Вмешательства

• Препарат CD-001
  CD-001 administered as an intravenous (IV) infusion.

Первичные конечные точки

• Number of Participants with Dose Limiting Toxicities (DLTs) [Срок оценки: 28 days]
• Incidence of AE and serious adverse events (SAE) [Срок оценки: Up to 3 Years]
• The recommended dose for expansion (RDE) and/ or maximum tolerated dose (MTD) of CD-001 monotherapy [Срок оценки: Up to 3 Years]

Вторичные конечные точки (9)

• Maximum Observed Plasma Concentration (Cmax) of CD-001 [Срок оценки: Up to 3 Years]
• Time to Achieve Cmax (Tmax) of CD-001 [Срок оценки: Up to 3 Years]
• Area Under the Plasma Concentration-time Curve (AUC) of CD-001 [Срок оценки: Up to 3 Years]
• Objective Response (OR) [Срок оценки: Up to 3 Years]
• Duration of Response (DOR) [Срок оценки: Up to 3 Years]
• Progression-Free Survival (PFS) [Срок оценки: Up to 1 Years]
• Disease Control Rate (DCR) [Срок оценки: Up to 3 Years]
• Overall Survival (OS) [Срок оценки: Up to 3 Years]
• Frequency of anti-drug antibody (ADA) to CD-001 [Срок оценки: Up to 3 Years]

Критерии участия

Критерии включения

• Age ≥ 18 years , regardless of gender.
• Patients with advanced solid tumors that are histologically or cytological confirmed, lacking standard therapy, progressing after adequate standard therapy, or intolerant of standard therapy.
• ECOG score ≤ 2.
• At least one measurable lesion as defined by RECIST v1.1.
• Expected survival ≥ 3 months.

Критерии исключения

• Patients with known active central nervous system (CNS) and/or leptomeningeal metastases .
• Patients who have undergone major organ surgery within 4 weeks prior to the first dosing, or who are expected to require major surgery during this study, or who have severe unhealed wounds, trauma, ulcers, etc.
• Patients who have previously undergone a major organ transplant, bone marrow transplant, or allogeneic stem-cell transplant.
• Patients who have a past or current history of active or chronic autoimmune disease and who have required systemic therapy within the past 2 years or is receiving systemic therapy for an autoimmune or inflammatory disease.
• Patients who have received anti-tumor therapy within 4 weeks or 5 drug half-lives (whichever is shorter) prior to the first dosing.
• At screening as determined by the investigator, the presence of any serious or uncontrollable disease or associated risk.
• Patients with a history of ≥ Grade 3 (CTCAE) immune-related adverse events (irAEs) during prior anti-tumor therapy or permanent drug discontinuation due to irAEs.
• Patients who have had a pulmonary embolism within 6 months prior to first dosing or have interstitial pneumonia at screening.

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

Китай · 1 центр

• Tianjin Medical University Cancer Institute&Hospital — Тяньцзинь

Идентификаторы

NCT: NCT06801470 · CD-001-CT101

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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