SYS6002 Plus JMT101 and Enlonstobart Injection in Participants With HNSCC

Официальное название

A Phase 2 Study of SYS6002 in Combination With JMT101 and Enlonstobart Injection in Participants With Recurrent and/or Metastatic Head and Neck Squamous Cell Cancer (HNSCC)

Обзор

This is a Phase II study of anti-nectin-4 ADC combined with the EGFR monoclonal antibody and the PD-1 monoclonal antibody in participants with advanced head and neck squamous cell carcinoma.

Подробное описание

This trial consists of two parts. Part 1 (Monotherapy Group) evaluates both SYS6002 monotherapy (stratified into two cohorts by dose levels and administration frequencies) and JMT101 monotherapy. Part 2 (Combination Therapy Group) comprises Stage 1 (dose escalation phase) and Stage 2 (proof-of-concept phase). Following completion of the dose escalation phase in Part 2 and evaluation of integrated efficacy and safety analyses of SYS6002 monotherapy in Part 1 of this study as well as other clinical studies involving participants with ≥2L HNSCC, the decision on progressing to Stage 2 of Part 2 will be made through discussion between the Sponsor and investigators.

Вмешательства

• Препарат JMT101
  JMT101 Q2W or Q3W, intravenous injection
• Препарат SYS6002
  SYS6002 Q2W or Q3W, intravenous injection
• Препарат SG001
  SG001 Q2W or Q3W, intravenous injection

Первичные конечные точки

• Dose-limiting Toxicities (DLTs) [Срок оценки: Up to 28 days]
• Incidence of Adverse Events (AEs) [Срок оценки: Up to approximately 2 years]
• Maximum Tolerated Dose (MTD) [Срок оценки: Up to approximately 2 years]
• Objective Response Rate (ORR) [Срок оценки: Up to approximately 2 years]

Вторичные конечные точки (4)

• Disease Control Rate (DCR) [Срок оценки: Up to approximately 2 years]
• Duration of Response (DOR) [Срок оценки: Up to approximately 2 years]
• Progression-free Survival (PFS) [Срок оценки: Up to approximately 2 years]
• Overall Survival (OS) [Срок оценки: Up to approximately 3 years]

Критерии участия

Критерии включения

• Aged 18 years or older, regardless of gender.
• Able to understand and voluntarily sign a written informed consent form (ICF).
• Confirmed recurrent or metastatic HNSCC that is not curable with local treatments. Primary tumor must be located in the oral cavity, oropharynx, hypopharynx, or larynx.
• Able to provide well-preserved or fresh tumor tissue.
• According to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, at least one measurable lesion confirmed by CT or MRI.
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.
• Life expectancy ≥ 3 months.
• Normal major organ function within 7 days prior to treatment.

Критерии исключения

• Primary tumor located in the nasopharynx, nasal cavity, paranasal sinuses, salivary glands, thyroid or parathyroid glands, skin, or squamous cell carcinoma with an unknown primary site.
• Presence of leptomeningeal metastasis, spinal cord compression, symptomatic or progressive brain metastases.
• (Only for Stage 2 in Part 2) Prior systemic anti-tumor therapy for recurrent or metastatic HNSCC.
• Known allergy to any component of SYS6002, JMT101, or Enlonstobart injection.
• Participants who have previously received MMAE toxin ADC treatment (only for Part 1 and Stage 2 in Part 2).
• Adverse events related to prior anti-tumor treatment that have not resolved to ≤ Grade 1 according to NCI-CTCAE v5.0 (except for toxicities deemed low-risk by the investigator, such as Grade 2 alopecia).
• Washout period not met for anti-tumor medications or treatments.
• Any serious and/or uncontrolled comorbid conditions that may interfere with the participant's ability to participate in the study
• Pregnant or breastfeeding women; women of childbearing potential with a positive pregnancy test within 7 days before enrollment. Breastfeeding women may participate if they stop breastfeeding, but they cannot resume breastfeeding during the treatment and after the study ends.
• Any male or female participants of childbearing potential who refuse to use highly effective contraception during the study and for 6 months after the last dose of study drug.
• Unwilling or unable to comply with the study procedures and requirements, or deemed unsuitable for participation by the investigator.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Факторный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06989671 · SYS6002-003

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗