Clinical trial · Interventional
IPH5401 (Anti-C5aR) in Combination With Durvalumab in Patients With Advanced Solid Tumors
A Phase I Study of the Anti-C5aR, IPH5401, in Combination With the Anti-PD-L1, Durvalumab, in Patients With Selected Advanced Solid Tumors
NCT03665129CI-TRIAL-00056202STELLAR-001terminatedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): early termination
Summary
Brief summary (as posted)
This is a multicenter, open-label, dose-escalation and dose-expansion study to evaluate the safety, tolerability, antitumor activity of IPH5401 (anti C5aR) in combination with Durvalumab (MEDI4736) in Adult Subjects with selected advanced solid tumors.
Conditions
Conditions (1)
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 Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| IPH5401 and Durvalumab | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Dose escalation
- description
- IPH5401 at different doses and schedule + Durvalumab
- interventionNames
- Biological: IPH5401 and Durvalumab
- type
- EXPERIMENTAL
- label
- Cohort expansion NSCLC anti-PD-(L)1 pretreated
- description
- IPH5401 at recommended dose and schedule + Durvalumab in NSCLC anti-PD-(L)1 pretreated patients
- interventionNames
- Biological: IPH5401 and Durvalumab
- type
- EXPERIMENTAL
- label
- Cohort expansion HCC anti-PD-(L)1 naive
- description
- IPH5401 at recommended dose and schedule + Durvalumab in HCC anti-PD-(L)1 naive patients
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients with advanced and/or metastatic histologically solid tumors with evidence of active disease, who have been treated with a minimum of one line of systemic therapy in the metastatic setting, and in expansion part, no more than two prior systemic therapies. 2. At least 18 years of age. 3. ECOG performance status of ≤1. 4. Adequate organ function Exclusion Criteria: 1. For patients with Non Small Cell Lung Cancer (NSCLC): a. Known actionable mutation or rearrangement (including but not limited to the epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK) gene rearrangements, ROS-1 alterations or BRAF mutations) 2. For patient with Hepatocellular carcinoma (HCC): 1. Hepatic encephalopathy in the past 12 months. 2. Ascites that requires repeated paracentesis in the past 2 months. 3. Main portal vein thrombosis. 4. Active or prior history of gastrointestinal bleeding in the past 12 months. 5. Prior hepatic transplantation. 3. Patients with known spinal cord compression. 4. Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases.
References
Publications (0)
Data not yet available
No reference posted for this study.