A Phase Ib/II Study of SYS6090 Combination Therapy in Advanced Colorectal Cancer

Официальное название

A Phase Ib/II Study to Evaluate the Safety, Tolerability, and Efficacy of SYS6090 in Combination With Other Therapies in Participants With Advanced Coloretal Cancer

Обзор

This study constitutes an open-label, multi-cohort, multi-center Phase Ib/II clinical study, developed to assess the safety, tolerability, and therapeutic efficacy of SYS6090 injection when administered in combination with bevacizumab, or in triple combination with bevacizumab and chemotherapy, among patients diagnosed with advanced colorectal cancer.

Вмешательства

• Препарат SYS6090 (Fixed Dose Level A) + bevacizumab
  Participants will receive intravenous SYS6090 at fixed dose level A combined with intravenous bevacizumab, administered per cycle schedule specified in study protocol, for advanced/palliative unresectable pMMR/MSS colorectal cancer.
• Препарат SYS6090 (Fixed Dose Level B ) + bevacizumab
  Participants will receive intravenous SYS6090 at fixed dose level B plus intravenous bevacizumab per protocol-defined cycle schedule for unresectable advanced pMMR/MSS colorectal cancer.
• Препарат SYS6090 RP2D + bevacizumab +mFOLFOX6
  Participants will receive intravenous SYS6090 at RP2D plus intravenous bevacizumab combined with standard mFOLFOX6 chemotherapy regimen (oxaliplatin, leucovorin, fluorouracil), administered per protocol-defined cycle schedule for unresectable advanced pMMR/MSS colorectal cancer.
• Препарат SYS6090 RP2D + bevacizumab
  Participants will receive intravenous SYS6090 at RP2D plus intravenous bevacizumab, administered per protocol-defined cycle schedule for unresectable advanced pMMR/MSS colorectal cancer.
• Препарат Regorafenib
  Oral regorafenib monotherapy as standard control for metastatic pMMR/MSS colorectal cancer.
• Препарат SYS6090 PR2D+ bevacizumab + FOLFOXIRI
  Participants will receive intravenous SYS6090at RP2D plus intravenous bevacizumab combined with FOLFOXIRI triple chemotherapy (oxaliplatin, irinotecan, leucovorin, fluorouracil) per study cycle schedule for metastatic pMMR/MSS colorectal cancer.
• Препарат bevacizumab + FOLFOXIRI
  Participants will receive intravenous bevacizumab combined with FOLFOXIRI triple chemotherapy (oxaliplatin, irinotecan, leucovorin, fluorouracil) per study cycle schedule for metastatic pMMR/MSS colorectal cancer.

Первичные конечные точки

• Recommended Phase 2 Dose (RP2D), Safety and Tolerability [Срок оценки: up to approximately 3 years after the first enrollment]
• Objective Response Rate (ORR) assessed per RECIST v1.1 [Срок оценки: up to approximately 3 years after the first enrollment]
• Progression-Free Survival (PFS) assessed per RECIST v1.1 [Срок оценки: up to approximately 3 years after the first enrollment]

Критерии участия

\*Eligibility Criteria:

Критерии включения

• Subjects must be ≥18 years of age.
• Histologically or cytologically confirmed unresectable advanced or metastatic colorectal cancer with pMMR/MSS status, assigned to corresponding cohorts as follows:

Cohort 1 (2L/3L) of Phase Ib \& Phase II: Subjects must have disease progression after no more than 2 lines of standard systemic therapy (prior regimens must contain fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy); tumor tissue confirmed as pMMR by IHC or MSS by NGS/PCR; Cohort 2 (1L) of Phase Ib \& Phase II: Subjects have received no prior systemic anti-tumor therapy for advanced disease; tumor tissue confirmed as pMMR by IHC or MSS by NGS/PCR.

• At least one extracranial measurable lesion at baseline according to RECIST 1.1 criteria.
• Eastern Cooperative Oncology Group performance status of 0 or 1.
• Expected survival ≥ 3 months.
• Has protocol-defined adequate organ and bone marrow function.

Критерии исключения

• Subjects with clinically active central nervous system metastases;
• with a history of other primary malignant tumors within 5 years before administration;
• Subjects assigned to Cohort 1 who have received prior regorafenib treatment.;
• Prior documented interstitial lung disease (ILD)/ pneumonitis that required steroids, current ILD/ pneumonitis, or suspected ILD/ pneumonitis that cannot be ruled out by imaging at screening;
• Uncontrolled or significant cardiovascular disease;
• Clinically uncontrolled pleural effusion, ascites or pericardial effusion;
• Has unresolved toxicities from previous anticancer therapy, defined as toxicities not yet resolved to Grade ≤ 1 or baseline .

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Fujian Cancer Hospital — Fujian

Идентификаторы

NCT: NCT07750041 · SYS6090-008

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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