Clinical trial · Interventional
A Study of Fruquintinib in Combination With Tislelizumab in Advanced Solid Tumors
An Open-Label, Phase 1b/2 Study to Evaluate the Safety and Efficacy of Fruquintinib in Combination With Tislelizumab in Patients With Advanced Solid Tumors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): At the time of study termination, both fruquintinib and tislelizumab are commercially available in the United States.
Summary
Brief summary (as posted)
This is an open-label, multi-center, non-randomized, Phase 1b/2 study to assess the safety and efficacy of fruquintinib in combination with tislelizumab in patients with locally advanced or metastatic solid tumors. This study will be conducted in 2 parts; a Safety Lead-in Phase (Part 1) and a Dose Expansion Phase (Part 2). The Safety Lead-in Phase, open to any-comer solid tumors, will determine the RP2D. The RP2D will be administered to 3 cohorts of patients in the Dose Expansion Phase. * Cohort A: Advanced or Metastatic Triple Negative Breast Cancer (TNBC) (IO-treated) * Cohort B: Advanced or Metastatic Triple Negative Breast Cancer (TNBC) (IO-Naïve) * Cohort C: Advanced or Metastatic Endometrial Cancer (EC) (IO-Naïve) * Cohort D: Advanced or Metastatic Colorectal Cancer (mCRC) (IO-Naïve)
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Endometrial Cancer | Malignant Endometrial Neoplasm | CURATED_BROADER | 0.80 |
| Solid Tumor, Unspecified, Adult | Adult Solid Neoplasm | ALIAS | 0.90 |
| Triple Negative Breast Cancer | Triple-Negative Breast Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fruquintinib | Drug | Fruquintinib | ALIAS |
| Tislelizumab | Drug | Tislelizumab | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Part 1
- description
- Approximately 6-12 patients with locally advanced or metastatic solid tumors will be enrolled to receive fruquintinib in combination with tislelizumab and assessed for DLTs during the 28-day DLT observation period
- interventionNames
- Drug: Fruquintinib
- Drug: Tislelizumab
- type
- EXPERIMENTAL
- label
- Part 2
- description
- Patients will be enrolled to one of the following expansion cohorts: * Cohort A: TNBC (immuno-oncology \[IO\]-treated in the metastatic setting) * Cohort B: TNBC (IO-Naïve in the metastatic setting) * Cohort C: EC * Cohort D: MSS CRC
- interventionNames
- Drug: Fruquintinib
- Drug: Tislelizumab
Primary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Willing and able to provide informed consent signed by study patient or legally acceptable representative, as specified by health authorities and institutional guidelines; 2. Age ≥18 years; 3. Histologically or cytologically documented, advanced or metastatic Triple Negative Breast Cancer, histologically or cytologically documented, advanced or metastatic endometrial carcinoma, histologically or cytologically confirmed advanced or metastatic, unresectable adenocarcinoma of the colon or rectum. 4. Tumor tissue (archival or fresh tumor tissues as formalin-fixed paraffin-embedded blocks or approximately 15 unstained slides) for central laboratory assessment. 5. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤1. 6. At least 1 measurable lesion as defined by RECIST v1.1. Exclusion Criteria: 1. Has at screening any central nervous system metastasis and/or leptomeningeal disease. 2. Except for Cohort A, 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. 3. Prior treatment with a VEGFR-TKI or anti-VEGFR antibody (eg, ramucirumab). 4. Except for Cohort D, prior treatment with an anti-VEGFR antibody (eg, bevacizumab). 5. Tumor tissue (archival or fresh tumor tissues as formalin-fixed paraffin-embedded blocks or approximately 15 unstained slides) for central laboratory assessment. 6. 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
References
Publications (0)
Data not yet available