IPH5401 (Anti-C5aR) in Combination With Durvalumab in Patients With Advanced Solid Tumors (STELLAR-001)
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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 :
Terminated
(early termination)
First Posted : September 11, 2018
Last Update Posted : January 27, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Advanced Solid Tumors | Biological: IPH5401 and Durvalumab | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 73 participants |
Allocation: | Non-Randomized |
Intervention Model: | Sequential Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase I Study of the Anti-C5aR, IPH5401, in Combination With the Anti-PD-L1, Durvalumab, in Patients With Selected Advanced Solid Tumors |
Actual Study Start Date : | September 7, 2018 |
Actual Primary Completion Date : | February 24, 2021 |
Actual Study Completion Date : | February 24, 2021 |

Arm | Intervention/treatment |
---|---|
Experimental: Dose escalation
IPH5401 at different doses and schedule + Durvalumab
|
Biological: IPH5401 and Durvalumab
IPH5401 and durvalumab |
Experimental: Cohort expansion NSCLC anti-PD-(L)1 pretreated
IPH5401 at recommended dose and schedule + Durvalumab in NSCLC anti-PD-(L)1 pretreated patients
|
Biological: IPH5401 and Durvalumab
IPH5401 and durvalumab |
Experimental: Cohort expansion HCC anti-PD-(L)1 naive
IPH5401 at recommended dose and schedule + Durvalumab in HCC anti-PD-(L)1 naive patients
|
Biological: IPH5401 and Durvalumab
IPH5401 and durvalumab |
Experimental: Cohort expansion HCC anti-PD-(L)1 pretreated
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) [ Time Frame: From Time of First dose assessed up to 6 weeks ]To assess the occurrence of Drug Limited Toxicities (DLTs)
- Adverse events (AEs) [ Time Frame: From screening visit up to 30 days after the last dose of study medication ]To evaluate the safety profile
- Objective Response Rate [ Time Frame: up to 12 months ]Rate of patients in complete or partial response according to RECIST 1.1
- Duration of Response [ Time Frame: 2 years and 9 months ]duration between the complete or partial response and the first documented progression
- Progression Free Survival [ Time Frame: 2 years and 9 months ]time between the start of treatment and the first documented progression or death

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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.
- At least 18 years of age.
- ECOG performance status of ≤1.
- Adequate organ function
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)
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For patient with Hepatocellular carcinoma (HCC):
- Hepatic encephalopathy in the past 12 months.
- Ascites that requires repeated paracentesis in the past 2 months.
- Main portal vein thrombosis.
- Active or prior history of gastrointestinal bleeding in the past 12 months.
- Prior hepatic transplantation.
- Patients with known spinal cord compression.
- Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03665129
United States, Kentucky | |
James Graham Brown Cancer Center | |
Louisville, Kentucky, United States, 40202 | |
United States, Minnesota | |
Park Nicollet Frauenshuh Cancer Center | |
Saint Louis Park, Minnesota, United States, 55426 | |
United States, New York | |
ICAHN School of Medicine at Mount Sinai | |
New York, New York, United States, 10029-6574 | |
United States, Tennessee | |
Sarah Cannon Research Institute | |
Nashville, Tennessee, United States, 37203 | |
United States, Texas | |
NEXT Oncology | |
San Antonio, Texas, United States, 78006 | |
France | |
Centre Georges-Francois Leclerc | |
Dijon, France | |
Centre Leon Berard | |
Lyon, France, 69373 | |
Hôpital de la Timone- AP-HM | |
Marseille, France | |
Institut du Cancer de Montpellier | |
Montpellier, France | |
Centre Hospitalier Universitaire- Hôpital Nord Laennec | |
Nantes, France | |
Centre Eugène Marquis | |
Rennes, France | |
Institut Gustave Roussy | |
Villejuif, France |
Responsible Party: | Innate Pharma |
ClinicalTrials.gov Identifier: | NCT03665129 |
Other Study ID Numbers: |
IPH5401-101 |
First Posted: | September 11, 2018 Key Record Dates |
Last Update Posted: | January 27, 2022 |
Last Verified: | January 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Neoplasms Avdoralimab Durvalumab Antineoplastic Agents, Immunological |
Antineoplastic Agents Anti-Inflammatory Agents Antiviral Agents Anti-Infective Agents |