A Study to Investigate the Pharmacokinetics and Safety of Subcutaneous Rilvegostomig in Adult Participants With Advanced Solid Tumors Previously Treated With Standard of Care Therapy

Официальное название

A Phase I, Multicenter, Dose Finding and Dose Confirmation Study to Investigate the Pharmacokinetics, and Safety of Subcutaneous Rilvegostomig in Adult Participants With Advanced Solid Tumors Previously Treated With Standard of Care Therapy (ARTEMIDE-subQ)

Обзор

The purpose of this study is to determine the subcutaneous (SC) dose that gives rilvegostomig exposure comparable to the intravenous (IV) exposure, and to evaluate the pharmacokinetics (PK) and safety of SC rilvegostomig in adult participants with advanced solid tumors previously treated with standard of care therapy for whom immunooncology (IO) monotherapy would be deemed appropriate by the investigator.

Подробное описание

This is a Phase I, open-label, multicenter, multi-part, dose finding and dose confirmation study to evaluate the PK and safety of SC rilvegostomig.

The study includes 2 parts: Part 1 (Dose Finding) and Part 2 (Dose Confirmation).

Part 1 will determine a SC rilvegostomig dose co-administered with rHu that yields drug exposure comparable with IV rilvegostomig. It will include 2 planned dose levels (DL1 in Cohort A and DL2 in Cohort B). Additional dose levels will be added, if needed.

Part 2 will be initiated once a dose has been identified based on Part 1. This part will evaluate the bioavailability, safety, and tolerability of SC rilvegostomig + rHu.

Вмешательства

• Препарат IV Rilvegostomig
  Rilvegostomig administered IV.
• Препарат Recombinant Human Hyaluronidase (rHu)
  rHu administered subcutaneously.
• Препарат SC Rilvegostomig
  Rilvegostomig administered subcutaneously.
• Препарат SC rilvegostomig + rHu
  SC rilvegostomig + rHu administered subcutaneously.

Первичные конечные точки

• Area under the Concentration-time Curve During One Dosing Interval (AUCtau) [Срок оценки: From Day 1 up to end of Cycle 2 in Part 1 and end of Cycle 1 in Part 2 (each cycle will be of 3 weeks)]

Вторичные конечные точки (5)

• Number of participants with adverse events (AEs) [Срок оценки: From Day 1 up to 90 days post last dose (Up to approximately 29 months)]
• Observed Lowest Concentration before the Next Dose is Administered (Ctrough) [Срок оценки: From first dose of study intervention (Day 1), at predefined intervals throughout the administration of rilvegostomig (approximately 29 months).]
• Average drug concentration over a dosing interval (Cavg) [Срок оценки: From first dose of study intervention (Day 1), at predefined intervals throughout the administration of rilvegostomig (approximately 29 months).]
• AUCtau [Срок оценки: From first dose of study intervention (Day 1), at predefined intervals throughout the administration of rilvegostomig (approximately 29 months).]
• Serum rilvegostomig concentration [Срок оценки: From first dose of study intervention (Day 1), at predefined intervals throughout the administration of rilvegostomig (approximately 29 months).]

Критерии участия

Критерии включения

• Histologically or cytologically documented advanced (metastatic and/or unresectable) solid tumor.
• Participants must have received prior anticancer treatment for the disease under study.
• IO monotherapy deemed appropriate by the investigator.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at enrollment with no deterioration.
• Minimum life expectancy of ≥ 12 weeks at enrollment.
• Adequate organ and marrow function.
• Body weight ≥ 30 kg.

Критерии исключения

• Any severe or uncontrolled systemic diseases, which makes it undesirable for the participant to participate in the study or that would jeopardize compliance with the protocol.
• History of organ transplant.
• History of another primary malignancy that was active within past 2 years.
• Persistent toxicities caused by previous anticancer treatment(s) excluding alopecia, not yet improved to Grade ≤ 1 or baseline.
• Unstable, symptomatic brain metastasis or spinal cord compression.
• History of leptomeningeal carcinomatosis.
• Active primary immunodeficiency/active infectious disease including tuberculosis (TB), human immunodeficiency virus (HIV) infection or hepatitis A, B or C infection.
• History of clinically significant arrhythmia, cardiomyopathy of any etiology; symptomatic congestive heart failure, history of myocardial infarction within the past 6 months.
• Uncontrolled intercurrent illness including but not limited to ongoing or active known infection; interstitial lung disease (ILD), serious chronic gastrointestinal conditions associated with diarrhea; active non-infectious skin disease requiring systemic treatment.
• Active or prior documented autoimmune or inflammatory disorders requiring chronic treatment with steroids or other immunosuppressive treatment.
• Known allergy or hypersensitivity to rilvegostomig, hyaluronidase, or any excipients of the investigational products.
• Participants experienced a toxicity to prior immunotherapy that led to permanent discontinuation of prior immunotherapy.
• Prior anticancer treatment, including immunotherapy, up to 28 days prior to the first dose of study treatment.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Испания · 4 центра

• Research Site — Barcelona
• Research Site — Barcelona
• Research Site — Madrid
• Research Site — Madrid

США · 3 центра

• Research Site — Huntersville
• Research Site — San Antonio
• Research Site — Fairfax

South Korea · 2 центра

• Research Site — Seoul
• Research Site — Seoul

Великобритания · 2 центра

• Research Site — Newcastle upon Tyne
• Research Site — Sutton

Идентификаторы

NCT: NCT07161414 · D702EC00001 · 2025-521614-26-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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