A Phase 1 interventional study of IPH5401 and Durvalumab in Advanced Solid Tumors, sponsored by Innate Pharma. Terminated at 12 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-01-27.
Sponsored by Innate Pharma · Phase 1, Interventional, and Treatment
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.
9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.
This study's enrollment of 73 is above the median of 50 across 7,253 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →Innate Pharma is the lead sponsor of 17 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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)
For patient with Hepatocellular carcinoma (HCC):
IPH5401 at different doses and schedule + Durvalumab
Biological: IPH5401 and Durvalumab
IPH5401 at recommended dose and schedule + Durvalumab in NSCLC anti-PD-(L)1 pretreated patients
Biological: IPH5401 and Durvalumab
IPH5401 at recommended dose and schedule + Durvalumab in HCC anti-PD-(L)1 naive patients
Biological: IPH5401 and Durvalumab
IPH5401 at recommended dose and schedule + Durvalumab in HCC anti-PD-(L)1 pretreated patients
Biological: IPH5401 and Durvalumab
IPH5401 and durvalumab
Occurrence of Drug Limited Toxicities (DLTs)
To assess the occurrence of Drug Limited Toxicities (DLTs)
Time frame: From Time of First dose assessed up to 6 weeks
Adverse events (AEs)
To evaluate the safety profile
Time frame: From screening visit up to 30 days after the last dose of study medication
Objective Response Rate
Rate of patients in complete or partial response according to RECIST 1.1
Time frame: up to 12 months
Duration of Response
duration between the complete or partial response and the first documented progression
Time frame: 2 years and 9 months
Progression Free Survival
time between the start of treatment and the first documented progression or death
Time frame: 2 years and 9 months
Plan to share: No
No publications or documents are linked to this record.
This study is terminated, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.
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Innate Pharma