Phase 2
Completed N=84
Efficacy and Safety of Tislelizumab in Combination With Fruquintinib in Participants With Selected Solid Tumors
Source: ClinicalTrials.gov NCT04716634 ↗Enrolled (actual)
84
Serious AEs
47.6%
Results posted
Mar 2025
Primary outcomePrimary: Part 1: Number of Participants With Dose Limiting Toxicities (DLTs) — 0 Participants
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 gastric cancer (GC), or colorectal cancer (CRC) or non-small cell lung cancer (NSCLC). The study was conducted in 2 parts. Part 1 was the safety run-in stage to determine dose-limiting toxicity (DLT) and recommended Phase 2 dose (RP2D). Part 2 assessed the preliminary efficacy of tislelizumab in combination with fruquintinib in participants as measured by the overall response rate (ORR) and other efficacy and safety profiles.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Part 1: Number of Participants With Dose Limiting Toxicities (DLTs) |
— | — |
| PRIMARY Part 1: Recommended Phase 2 Dose (RP2D) |
5.0 | — |
| PRIMARY Objective Response Rate (ORR) as Assessed by the Investigator Based on Response Evaluation Criteria in Solid Tumors (RECIST) Version (v)1.1 |
12.9; 9.7; 40.9 | — |
| SECONDARY Progression-Free Survival (PFS) as Assessed by Investigator Based on RECIST v1.1 |
4.6; 4.6; 15.6 | — |
| SECONDARY Disease Control Rate (DCR) as Assessed by the Investigator Based on RECIST v1.1 |
74.2; 74.2; 68.2 | — |
| SECONDARY Clinical Benefit Rate (CBR) as Assessed by the Investigator Based on RECIST v1.1 |
32.3; 38.7; 59.1 | — |
| SECONDARY Duration of Response (DOR) as Assessed by The Investigator Based on RECIST v1.1 |
NA; 11.9; NA | — |
| SECONDARY Overall Survival (OS) |
10.5; 10.0; NA | — |
| SECONDARY Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs, Grade 3 or Higher TEAEs, TEAEs Leading to Death, TEAEs Related to Tislelizumab, TEAEs Related to Fruquintinib |
30; 31; 22; 13; 14; 13 | — |
Eligibility Criteria
Key Inclusion Criteria
- 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 Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT04716634). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.