Clinical trial · Interventional
A Study to Evaluate Lucitanib in Combination With Nivolumab in Patients With a Solid Tumor
LIO-1: A Phase 1b/2, Open-Label Study to Evaluate the Safety and Efficacy of Lucitanib in Combination With Nivolumab in Patients With An Advanced, Metastatic Solid Tumor
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Company decision
Summary
Brief summary (as posted)
This is an open-label, Phase 1b/2 study to determine the recommended dose of lucitanib in combination with nivolumab in patients with an advanced solid tumor (Phase 1b); followed by evaluation of the safety and efficacy of lucitanib and nivolumab in patients with an advanced gynecological solid tumor (Phase 2) and evaluate the effects of dosing under fasting or fed state (Food Effect)
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
| Gynecologic Cancer | Malignant Female Reproductive System Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
Design
Arms and outcomes
Arms (6)
- type
- EXPERIMENTAL
- label
- Phase 1b: Dose Escalation
- description
- \- Up to 50 patients with advanced solid tumor
- interventionNames
- Drug: Lucitanib
- Drug: Nivolumab
- type
- EXPERIMENTAL
- label
- Phase 1b: Food Effect Cohort
- description
- \- Approximately 16 evaluable patients with an advanced, metastatic solid tumor will be enrolled
- interventionNames
- Drug: Lucitanib
- Drug: Nivolumab
- type
- EXPERIMENTAL
- label
- Phase 2: Expansion Cohort - Endometrial Cancer
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
General Inclusion Criteria: * ≥ 18 years of age * Adequate organ function * Life expectancy ≥ 3 months * Women of childbearing potential must have a negative serum pregnancy test * Advanced/metastatic solid tumor (Phase 1b) * Availability of tumor tissue at screening * ECOG performance status of 0 to 1 * Measurable disease (RECIST v1.1) (Phase 2) * Advanced, recurrent, or metastatic gynecological solid tumor (Phase 2) * Willing and able to fast, and to eat a high-fat breakfast (Food Effect) General Exclusion Criteria: * Prior treatment with lucitanib * Active second malignancy * Active central nervous system brain metastases * Pre-existing duodenal stent or any gastrointestinal disorder * Known history of HIV or AIDs; positive result of hepatitis B or C viruses * Evidence of interstitial lung disease, active pneumonitis, myocarditis, or history of myocarditis * Active, known or suspected autoimmune disease (eg, autoimmune hepatitis) * Condition requiring systemic treatment with corticosteroids or other immune suppressive medications * Unstable or uncontrolled hypertension (BP ≥ 140/90 mmHg) * Prior treatment with a VEGFR-tyrosine kinase inhibitor (Phase 2)
References
Publications (0)
Data not yet available