Status:
COMPLETED
Efficacy and Safety of Tislelizumab in Combination With Fruquintinib in Participants With Selected Solid Tumors
Lead Sponsor:
BeiGene
Collaborating Sponsors:
Hutchison Medipharma Limited
Conditions:
Advanced Solid Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This was an open label, multicenter, Phase 2 study designed to assess the efficacy and safety of tislelizumab in combination with fruquintinib in participants with advanced or metastatic, unresectable...
Detailed Description
This was an open label, multicenter, Phase 2 study designed to assess the efficacy and safety of tislelizumab in combination with fruquintinib in patients with advanced or metastatic, unresectable GC,...
Eligibility Criteria
Inclusion
- Key
- Signed informed consent form (ICF) and able to comply with study requirements.
- At least 1 measurable lesion as defined by RECIST v1.1
- Tumor tissue (archival tumor tissues as formalin-fixed paraffin-embedded blocks or approximately 15 unstained slides) for central laboratory assessment
- Eastern Cooperative Oncology Group (ECOG) Performance Status less than or equal to (\<=) 1
- Histologically or cytologically confirmed, advanced or metastatic, unresectable adenocarcinoma of gastric or esophagogastric junction or colon or rectum, and histologically or cytologically confirmed, locally advanced (Stage IIIB) not amenable to curative surgery or radiotherapy, or metastatic (Stage IV) NSCLC
- Key
Exclusion
- Had at screening any central nervous system metastasis and/or leptomeningeal disease
- Prior therapy targeting CTLA-4, PD-1, PD-L1 or programmed cell death protein ligand-2 (PD-L2) or any other antibody or drug specifically targeting T-cell costimulation or checkpoint pathways
- Prior treatment with VEGFR-TKI or anti-VEGFR antibody (eg, ramucirumab)
- Received more than 1 line of systemic treatment for advanced or metastatic, unresectable adenocarcinoma of gastric or esophagogastric junction, or more than 2 lines of systemic treatment for advanced or metastatic, unresectable adenocarcinoma of the colon or rectum, or prior systemic therapy for advanced or metastatic NSCLC
- Active autoimmune diseases or history of autoimmune diseases that may relapse, or history of interstitial lung disease, noninfectious pneumonitis, or uncontrolled lung diseases including but not limited to pulmonary fibrosis, acute lung diseases, etc.
- NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Key Trial Info
Start Date :
April 19 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 22 2024
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT04716634
Start Date
April 19 2021
End Date
February 22 2024
Last Update
March 25 2025
Active Locations (13)
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1
Fujian Cancer Hospital
Fuzhou, Fujian, China, 350014
2
The First Hospital of Lanzhou University
Lanzhou, Gansu, China, 730000
3
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China, 150000
4
Henan Cancer Hospital
Zhengzhou, Henan, China, 450000