IPH5401 (Anti-C5aR) in Combination With Durvalumab in Patients With Advanced Solid Tumors (STELLAR-001)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03665129 |
Recruitment Status :
Active, not recruiting
First Posted : September 11, 2018
Last Update Posted : January 22, 2021
|
Sponsor:
Innate Pharma
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Innate Pharma
Tracking Information | |||||
---|---|---|---|---|---|
First Submitted Date ICMJE | September 1, 2018 | ||||
First Posted Date ICMJE | September 11, 2018 | ||||
Last Update Posted Date | January 22, 2021 | ||||
Actual Study Start Date ICMJE | September 7, 2018 | ||||
Estimated Primary Completion Date | June 2021 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
|
||||
Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
|
||||
Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | IPH5401 (Anti-C5aR) in Combination With Durvalumab in Patients With Advanced Solid Tumors | ||||
Official Title ICMJE | A Phase I Study of the Anti-C5aR, IPH5401, in Combination With the Anti-PD-L1, Durvalumab, in Patients With Selected Advanced Solid Tumors | ||||
Brief Summary | 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. | ||||
Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 1 | ||||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Sequential Assignment Masking: None (Open Label) Primary Purpose: Treatment |
||||
Condition ICMJE | Advanced Solid Tumors | ||||
Intervention ICMJE | Biological: IPH5401 and Durvalumab
IPH5401 and durvalumab
|
||||
Study Arms ICMJE |
|
||||
Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
Recruitment Information | |||||
Recruitment Status ICMJE | Active, not recruiting | ||||
Actual Enrollment ICMJE |
73 | ||||
Original Estimated Enrollment ICMJE |
100 | ||||
Estimated Study Completion Date ICMJE | June 2021 | ||||
Estimated Primary Completion Date | June 2021 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||
Sex/Gender ICMJE |
|
||||
Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | France, United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03665129 | ||||
Other Study ID Numbers ICMJE | IPH5401-101 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
|
||||
IPD Sharing Statement ICMJE |
|
||||
Responsible Party | Innate Pharma | ||||
Study Sponsor ICMJE | Innate Pharma | ||||
Collaborators ICMJE | AstraZeneca | ||||
Investigators ICMJE | Not Provided | ||||
PRS Account | Innate Pharma | ||||
Verification Date | January 2021 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |