First-in-Human Study of ADCE-D01 in Soft Tissue Sarcoma

Официальное название

A First-in-human, Phase 1/2, Multicenter, Open-label, Dose Escalation and Expansion Study to Evaluate the Safety, Pharmacokinetics, and Antitumor Activity of ADCE-D01, a Humanized Anti-human uPARAP Antibody Linked to a Topoisomerase I Inhibitor, in Patients With Metastatic and/or Unresectable Soft Tissue Sarcoma

Обзор

The goal of this clinical trial is to learn about the safety, tolerability and efficacy of ADCE-D01.

Подробное описание

Safety and Tolerability evaluated by incidence of DLTs. Efficacy evaluated by antitumor activity; ORR, DOR, PFS, CBR and TTR per RECIST v i.1.

Вмешательства

• Биопрепарат Antibody-drug conjugate (ADC)
  ADCE-D01 is an antibody-drug conjugate (ADC) composed of an anti-urokinase plasminogen activator receptor-associated protein (uPARAP) antibody, AB-004, conjugated to a topoisomerase I inhibitor, P1021, via a protease cleavage tetra-peptide linker.

Первичные конечные точки

• Determine the MTD/maximum administered dose and RP2DS of ADCE-D01. [Срок оценки: From enrollment to the end of Phase 1b (Approximately 18 months after enrollment)]
• Assess the safety and tolerability of ADCE-D01 [Срок оценки: Throughout the trial duration, completion expected approximately 18 months from completed enrollment]

Вторичные конечные точки (8)

• Maximum concentration (Cmax) [Срок оценки: Throughout the trial duration, completion expected approximately 18 months from completed enrollment]
• ADCE-D01 time to Cmax (Tmax) [Срок оценки: Throughout the trial duration, completion expected approximately 18 months from completed enrollment]
• ADCE-D01 area under the concentration-time curve (AUC) [Срок оценки: Throughout the trial duration, completion expected approximately 18 months from completed enrollment]
• Evaluate ADCE-D01 objective response rate (ORR) [Срок оценки: Throughout the trial duration, completion expected approximately 18 months from completed enrollment]
• Evaluate ADCE-D01 duration of response (DOR) [Срок оценки: Throughout the trial duration, completion expected approximately 18 months from completed enrollment]
• ADCE-D01 progression-free survival (PFS) [Срок оценки: Throughout the trial duration, completion expected approximately 18 months from completed enrollmen]
• ADCE-D01 clinical benefit rate (CBR) [Срок оценки: Throughout the trial duration, completion expected approximately 18 months from completed enrollment]
• ADCE-D01 time to response (TTR) [Срок оценки: Throughout the trial duration, completion expected approximately 18 months from completed enrollment]

Критерии участия

Критерии включения

• ≥ 18 years of age
• Histologically confirmed STS with metastatic and/or unresectable disease (not amenable to treatment with curative intent).
• Prior treatment with at least one but no more than two lines of cytotoxic systemic therapy for metastatic/unresectable disease.
• Measurable disease as per RECIST v 1.1.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Life expectancy of at least 3 months.
• A male patient must agree to use barrier contraception during the treatment period and for at least 4 months after the last infusion of study treatment, and refrain from donating sperm during this period. Male patients with a pregnant partner must practice sexual abstinence or use a barrier method of contraception (e.g., condom) to prevent exposure of the fetus or neonate.
• A female patient is eligible if not pregnant, not breast feeding, and not a woman of childbearing potential (WOCBP), or agrees to follow the contraceptive guidance during the treatment period and for at least 7 months after last infusion of study treatment.

Критерии исключения

• Patients who have had systemic anticancer therapy, including any investigational agent within 4 weeks or 5 half-lives (whichever is shorter) prior to study treatment administration.
• Primary brain malignancy or known, untreated central nervous system (CNS) or leptomeningeal metastases, or symptoms suggesting CNS involvement.
• Clinically significant cardiovascular disease
• Patients with acute infection with human immunodeficiency virus (HIV) 1 or HIV 2.
• Current active liver disease due to hepatitis B
• History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on a chest computed tomography (CT) scan at screening.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 4 центра

• University of Colorado Denver — Aurora
• University of Miami - Sylvester Comprehensive Cancer Center — Miami
• Memorial Sloan Kettering Cancer Center — New York
• University Of Texas MD Anderson Cancer Center — Houston

Бельгия · 1 центр

• Universitair Ziekenhuis Leuven (UZ Leuven) - Campus Gasthuisberg — Leuven

Франция · 1 центр

• Centre Léon Bérard — Lyon

Германия · 1 центр

• Universitätsklinikum Essen West German Tumor Center — Essen

Великобритания · 1 центр

• Royal Marsden — London

Идентификаторы

NCT: NCT06797999 · ADCE-D01-001 · 2024-516900-41-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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