Advanced Solid TumorsPhase 1STELLAR-001NCT03665129
IPH5401 (Anti-C5aR) in Combination With Durvalumab in Patients With Advanced Solid Tumors
A Phase 1 study testing IPH5401 and Durvalumab in people with Advanced Solid Tumors, run by Innate Pharma at 12 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- IPH5401 and Durvalumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 12 sitesin 2 countries
- Study dates
- 7 Sep 2018to 24 Feb 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- For patients with Non Small Cell Lung Cancer (NSCLC):
- 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):
- Hepatic encephalopathy in the past 12 months.
- Ascites that requires repeated paracentesis in the past 2 months.
- Main portal vein thrombosis.
Show all 10Show fewer
- 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.
Trial locations and contacts
12 sites in 2 countries.
12 sites in 2 countries
France7 sites
Centre Georges-Francois Leclerc
Dijon
Centre Leon Berard
Lyon, 69373
Hôpital de la Timone- AP-HM
Marseille
Institut du Cancer de Montpellier
Montpellier
Centre Hospitalier Universitaire- Hôpital Nord Laennec
Nantes
Centre Eugène Marquis
Rennes
Institut Gustave Roussy
Villejuif
United States5 sites
James Graham Brown Cancer Center
Louisville, Kentucky, 40202
Sarah Cannon Research Institute
Nashville, Tennessee, 37203
ICAHN School of Medicine at Mount Sinai
New York, New York, 10029-6574
Park Nicollet Frauenshuh Cancer Center
Saint Louis Park, Minnesota, 55426
NEXT Oncology
San Antonio, Texas, 78006
About this study
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
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
- Advanced Solid Tumors
- Being tested
- IPH5401 and Durvalumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IPH5401 and DurvalumabBiological
IPH5401 and durvalumab
| Study group | Role | What they receive |
|---|---|---|
| Dose escalation | Experimental | IPH5401 at different doses and schedule + Durvalumab Receives: Biological: IPH5401 and Durvalumab |
| Cohort expansion NSCLC anti-PD-(L)1 pretreated | Experimental | IPH5401 at recommended dose and schedule + Durvalumab in NSCLC anti-PD-(L)1 pretreated patients Receives: Biological: IPH5401 and Durvalumab |
| Cohort expansion HCC anti-PD-(L)1 naive | Experimental | IPH5401 at recommended dose and schedule + Durvalumab in HCC anti-PD-(L)1 naive patients Receives: Biological: IPH5401 and Durvalumab |
| Cohort expansion HCC anti-PD-(L)1 pretreated | Experimental | IPH5401 at recommended dose and schedule + Durvalumab in HCC anti-PD-(L)1 pretreated patients Receives: Biological: IPH5401 and Durvalumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of Drug Limited Toxicities (DLTs)
To assess the occurrence of Drug Limited Toxicities (DLTs)
Measured: From Time of First dose assessed up to 6 weeks
Adverse events (AEs)
To evaluate the safety profile
Measured: From screening visit up to 30 days after the last dose of study medication
Secondary outcomes (3)
Objective Response Rate
Rate of patients in complete or partial response according to RECIST 1.1
Measured: up to 12 months
Duration of Response
duration between the complete or partial response and the first documented progression
Measured: 2 years and 9 months
Progression Free Survival
time between the start of treatment and the first documented progression or death
Measured: 2 years and 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2018
- Study start7 Sep 2018
- Primary completion24 Feb 2021
- Study completion24 Feb 2021
Why it stopped: early termination
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Innate Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- AstraZeneca
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03665129
- Sponsor's protocol ID
- IPH5401-101
- Acronym
- STELLAR-001
- Status last verified
- Jan 2022
- First submitted
- 1 Sep 2018
- Last updated
- 27 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03665129
- Acronym / sponsor ID
- STELLAR-001 / IPH5401-101
- Conditions
- Advanced Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: early termination
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Innate PharmaIndustry (pharma, biotech, devices)
- Collaborators
- AstraZeneca
- Study start
- 7 Sep 2018 (actual)
- Primary completion
- 24 Feb 2021 (actual)
- Study completion
- 24 Feb 2021 (actual)
- First posted
- 11 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Dose escalation | Experimental | Biological: IPH5401 and DurvalumabIPH5401 at different doses and schedule + Durvalumab |
| Cohort expansion NSCLC anti-PD-(L)1 pretreated | Experimental | Biological: IPH5401 and DurvalumabIPH5401 at recommended dose and schedule + Durvalumab in NSCLC anti-PD-(L)1 pretreated patients |
| Cohort expansion HCC anti-PD-(L)1 naive | Experimental | Biological: IPH5401 and DurvalumabIPH5401 at recommended dose and schedule + Durvalumab in HCC anti-PD-(L)1 naive patients |
| Cohort expansion HCC anti-PD-(L)1 pretreated | Experimental | Biological: IPH5401 and DurvalumabIPH5401 at recommended dose and schedule + Durvalumab in HCC anti-PD-(L)1 pretreated patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- For patients with Non Small Cell Lung Cancer (NSCLC):
- For patient with Hepatocellular carcinoma (HCC):
- Patients with known spinal cord compression.
- Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IPH5401 and DurvalumabIPH5401 and durvalumab | Biological | Cohort expansion HCC anti-PD-(L)1 naive, Cohort expansion HCC anti-PD-(L)1 pretreated, Cohort expansion NSCLC anti-PD-(L)1 pretreated, Dose escalation |
Primary outcome
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
3 secondary outcomes
Objective Response Rate
Time frame: up to 12 months
Duration of Response
Time frame: 2 years and 9 months
Progression Free Survival
Time frame: 2 years and 9 months
Results and safety
The study was stopped early (reason given: early termination). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
12 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing IPH5401 and Durvalumab in people with Advanced Solid Tumors, run by Innate Pharma at 12 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in France, United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: early termination). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of Drug Limited Toxicities (DLTs) (time frame: From Time of First dose assessed up to 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2022.