Clinical trial · Interventional
IPH5201 as Monotherapy or in Combination With Durvalumab +/- Oleclumab in Subjects With Advanced Solid Tumors.
A Phase 1, First-in-Human, Multicenter, Open-label, Dose-escalation Study of IPH5201 as Monotherapy or in Combination With Durvalumab ± Oleclumab in Advanced Solid Tumors
NCT04261075CI-TRIAL-00060314completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to assess the safety and tolerability and to determine the dose of IPH5201 that can be used as monotherapy or in combination with durvalumab +/- oleclumab in subjects with 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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| durvalumab | Biological | Durvalumab | ALIAS |
| IPH5201 | Biological | — | UNRESOLVED |
| oleclumab | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- IPH5201 monotherapy dose escalation
- description
- IPH5201 monotherapy
- interventionNames
- Biological: IPH5201
- type
- EXPERIMENTAL
- label
- IPH5201 dose escalation with durvalumab
- description
- IPH5201 plus durvalumab
- interventionNames
- Biological: IPH5201
- Biological: durvalumab
- type
- EXPERIMENTAL
- label
- IPH5201 dose escalation with durvalumab + oleclumab
- description
- IPH5201 plus durvalumab and oleclumab
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 101 Years
Show eligibility criteria text
Inclusion Criteria: * Adult subjects; age ≥ 18 years * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1. * Subjects diagnosed with advanced solid tumors. * For Part 1 and Part 2 (IPH5201 in monotherapy or combined with durvalumab):Subjects must be refractory to standard therapy or for which no standard therapy exists. * For Part 3 (IPH5201 combined with durvalumab and oleclumab): Subjects must have received and radiologically progressed on 1 prior line of systemic therapy for metastatic pancreatic ductal adenocarcinoma. * Subjects must have at least 1 measurable lesion according to RECIST v1.1. * Subjects must provide tumor specimens . Exclusion Criteria: * Receipt of any conventional or investigational anticancer therapy (anti-CTLA-4, anti-PD-1, anti-PD-L1 antibodies) within 21 days of the planned first dose. * Receipt of agents targeting CD73, CD39, or adenosine receptors. * Concurrent enrollment in another therapeutic clinical study. * Any toxicity (excluding alopecia) from prior standard therapy that has not been completely resolved to baseline at the time of consent. * No toxicity leading to permanent discontinuation of prior IO therapy * Subjects must not have required the use of additional immunosuppression other than corticosteroids * Active or prior documented autoimmune or inflammatory disorders within the past 5 years * Cardiac and vascular criteria: * Presence of myocardial infarction or unstable angina , or stroke, within 6 months. * Congestive heart failure, serious cardiac arrhythmia requiring medication, or uncontrolled hypertension * History of severe hypertension * History of any grade of blood clot within 6 months * Active infection, including tuberculosis; hepatitis B virus (HBV); hepatitis C virus (HCV); or human immunodeficiency virus (HIV) * Uncontrolled illness including certain lung diseases, uncontrolled diabetes, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study. * Other invasive malignancy within 2 years. * Major surgery within 28 days prior to first dose * Female subjects who are pregnant or breast feeding
References
Publications (0)
Data not yet available
No reference posted for this study.