Advanced Solid TumorsPhase 1NCT04261075
IPH5201 as Monotherapy or in Combination With Durvalumab +/- Oleclumab in Subjects With Advanced Solid Tumors.
A Phase 1 study testing IPH5201, durvalumab and oleclumab in people with Advanced Solid Tumors, run by MedImmune LLC at 8 sites in 4 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 101 years
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- IPH5201, durvalumab and oleclumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 8 sitesin 4 countries
- Study dates
- 3 Mar 2020to 16 Jun 2022
- 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 to 101 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 .
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
8 sites in 4 countries.
8 sites in 4 countries
United States3 sites
Research Site
Huntersville, North Carolina, 28078
Research Site
Nashville, Tennessee, 37203
Research Site
Providence, Rhode Island, 02906
About this study
Official title: 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
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.
Read the detailed description
Study D6770C00001 is a Phase 1, first-in-human, multicenter, open-label, dose-escalation study to evaluate the safety, tolerability, antitumor activity, pharmacokinetics, and immunogenicity of IPH5201 in adult subjects with advanced solid tumors, when administered as monotherapy or in combination with durvalumab ± oleclumab.
- Conditions
- Advanced Solid Tumors
- Being tested
- IPH5201, durvalumab, oleclumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IPH5201Biological
Ascending dose levels of IPH5201 every 3 weeks (Q3W) for a maximum of 2 years
durvalumabBiological
Durvalumab Q3W for a maximum of 2 years
oleclumabBiological
Oleclumab Q3W for a maximum of 2 years
| Study group | Role | What they receive |
|---|---|---|
| IPH5201 monotherapy dose escalation | Experimental | IPH5201 monotherapy Receives: Biological: IPH5201 |
| IPH5201 dose escalation with durvalumab | Experimental | IPH5201 plus durvalumab Receives: Biological: IPH5201; Biological: durvalumab |
| IPH5201 dose escalation with durvalumab + oleclumab | Experimental | IPH5201 plus durvalumab and oleclumab Receives: Biological: IPH5201; Biological: durvalumab; Biological: oleclumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events as a measure of safety
The primary endpoint is safety as assessed by the presence of adverse events (AEs), serious adverse events (SAEs), and dose limiting toxicities (DLTs).
Measured: From time of informed consent through treatment period and including the follow-up 12 weeks after last dose of investigational product, approximately 7 months
Incidence of clinically significant laboratory values as a measure of safety
Number of subjects with clinically significant laboratory values from baseline including blood counts, liver, kidney and pancreas tests, electrolytes, and blood clotting.
Measured: From time of informed consent through 12 weeks after the last dose of investigational product, approximately 7 months
Incidence of clinically significant electrocardiogram (ECG) abnormalities as a measure of safety
12 lead ECGs will be measured to identify clinical significant abnormalities including ECGs that demonstrate a QTcF value >500ms, 2 additional 12-lead ECGs should be obtained over a 30 minute time period to confirm prolongation based on the average QTcF value
Measured: From time of informed consent through treatment period and including the follow-up period 12 weeks after last dose of investigational product, approximatley 7 months
Secondary outcomes (10)
OR (Objective Response; Response evaluation criteria in solid tumors [RECIST] v1.1)
Evaluate the primary antitumor activity of IPH5201 monotherapy or in combination with durvalumab +/- oleclumab (disease control)
Measured: From time of consent until date of first documented disease progression (approximately 4 months)
DC (Disease Control; RECIST 1.1)
Evaluate the primary antitumor activity of IPH5201 with durvalumab +/- oleclumab (disease control)
Measured: From time of consent until date of first documented disease progression (approximately 4 months)
Half-life of IPH5201
To characterize the pharmacokinetics of IPH5201 as monotherapy and in combination with durvalumab ± oleclumab
Measured: From start of treatment through Cycle 6 (21 day cycle, approximately 5 months)
Maximum serum concentration (Cmax) of IPH5201
To characterize the pharmacokinetics of IPH5201 as monotherapy and in combination with durvalumab ± oleclumab
Measured: From start of treatment through Cycle 6 (21 day cycle, approximately 5 months)
Area under the curve (AUC) of IPH5201
To characterize the pharmacokinetics of IPH5201 as monotherapy and in combination with durvalumab ± oleclumab
Measured: From start of treatment through Cycle 6 (21 day cycle, approximately 5 months)
Serum trough concentrations (durvalumab)
To determine the pharmacokinetics of durvalumab when administered in combination with IPH5201+/- oleclumab
Measured: From start of treatment through Cycle 6 (21 day cycle, approximately 5 months)
Serum trough concentrations (oleclumab)
To determine the pharmacokinetics of oleclumab in combination with durvalumab and IPH5201
Measured: From start of treatment through Cycle 6 (21 day cycle, approximately 5 months)
Incidence of antidrug antibodies (IPH5201)
To determine the immunogenicity of IPH5201 as monotherapy and in combination with durvalumab ± oleclumab
Measured: From start of treatment until 90 days after end of treatment (approximately 7 months)
Incidence of antidrug antibodies (durvalumab)
To determine the immunogenicity of durvalumab in combination with IPH5201 ± oleclumab
Measured: From start of treatment until 90 days after end of treatment (approximately 7 months)
Incidence of antidrug antibodies (oleclumab)
To determine the immunogenicity of oleclumab in combination with IPH5201 + durvalumab
Measured: From start of treatment until 90 days after end of treatment (approximately 7 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2020
- Study start3 Mar 2020
- Primary completion16 Jun 2022
- Study completion16 Jun 2022
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
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- MedImmune LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04261075
- Sponsor's protocol ID
- D6770C00001
- Status last verified
- Aug 2022
- First submitted
- 7 Jan 2020
- Last updated
- 15 Aug 2022
- Results posted
- 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 15 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04261075
- Acronym / sponsor ID
- D6770C00001
- Conditions
- Advanced Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- MedImmune LLCIndustry (pharma, biotech, devices)
- Study start
- 3 Mar 2020 (actual)
- Primary completion
- 16 Jun 2022 (actual)
- Study completion
- 16 Jun 2022 (actual)
- First posted
- 7 Feb 2020 (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.
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.
Detailed description
Study D6770C00001 is a Phase 1, first-in-human, multicenter, open-label, dose-escalation study to evaluate the safety, tolerability, antitumor activity, pharmacokinetics, and immunogenicity of IPH5201 in adult subjects with advanced solid tumors, when administered as monotherapy or in combination with durvalumab ± oleclumab.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| IPH5201 monotherapy dose escalation | Experimental | Biological: IPH5201IPH5201 monotherapy |
| IPH5201 dose escalation with durvalumab | Experimental | Biological: IPH5201, Biological: durvalumabIPH5201 plus durvalumab |
| IPH5201 dose escalation with durvalumab + oleclumab | Experimental | Biological: IPH5201, Biological: durvalumab, Biological: oleclumabIPH5201 plus durvalumab and oleclumab |
Who may qualify
- Ages
- 18 to 101 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (17 listed)
- 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.
- Active or prior documented autoimmune or inflammatory disorders within the past 5 years
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 |
|---|---|---|
| IPH5201Ascending dose levels of IPH5201 every 3 weeks (Q3W) for a maximum of 2 years | Biological | IPH5201 dose escalation with durvalumab, IPH5201 dose escalation with durvalumab + oleclumab, IPH5201 monotherapy dose escalation |
| durvalumabDurvalumab Q3W for a maximum of 2 years | Biological | IPH5201 dose escalation with durvalumab, IPH5201 dose escalation with durvalumab + oleclumab |
| oleclumabOleclumab Q3W for a maximum of 2 years | Biological | IPH5201 dose escalation with durvalumab + oleclumab |
Primary outcome
Incidence of adverse events as a measure of safety
Time frame: From time of informed consent through treatment period and including the follow-up 12 weeks after last dose of investigational product, approximately 7 months
The primary endpoint is safety as assessed by the presence of adverse events (AEs), serious adverse events (SAEs), and dose limiting toxicities (DLTs).
Incidence of clinically significant laboratory values as a measure of safety
Time frame: From time of informed consent through 12 weeks after the last dose of investigational product, approximately 7 months
Number of subjects with clinically significant laboratory values from baseline including blood counts, liver, kidney and pancreas tests, electrolytes, and blood clotting.
Incidence of clinically significant electrocardiogram (ECG) abnormalities as a measure of safety
Time frame: From time of informed consent through treatment period and including the follow-up period 12 weeks after last dose of investigational product, approximatley 7 months
12 lead ECGs will be measured to identify clinical significant abnormalities including ECGs that demonstrate a QTcF value >500ms, 2 additional 12-lead ECGs should be obtained over a 30 minute time period to confirm prolongation based on the average QTcF value
10 secondary outcomes
OR (Objective Response; Response evaluation criteria in solid tumors [RECIST] v1.1)
Time frame: From time of consent until date of first documented disease progression (approximately 4 months)
DC (Disease Control; RECIST 1.1)
Time frame: From time of consent until date of first documented disease progression (approximately 4 months)
Half-life of IPH5201
Time frame: From start of treatment through Cycle 6 (21 day cycle, approximately 5 months)
Maximum serum concentration (Cmax) of IPH5201
Time frame: From start of treatment through Cycle 6 (21 day cycle, approximately 5 months)
Area under the curve (AUC) of IPH5201
Time frame: From start of treatment through Cycle 6 (21 day cycle, approximately 5 months)
Serum trough concentrations (durvalumab)
Time frame: From start of treatment through Cycle 6 (21 day cycle, approximately 5 months)
Serum trough concentrations (oleclumab)
Time frame: From start of treatment through Cycle 6 (21 day cycle, approximately 5 months)
Incidence of antidrug antibodies (IPH5201)
Time frame: From start of treatment until 90 days after end of treatment (approximately 7 months)
Incidence of antidrug antibodies (durvalumab)
Time frame: From start of treatment until 90 days after end of treatment (approximately 7 months)
Incidence of antidrug antibodies (oleclumab)
Time frame: From start of treatment until 90 days after end of treatment (approximately 7 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 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.
8 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing IPH5201, durvalumab and oleclumab in people with Advanced Solid Tumors, run by MedImmune LLC at 8 sites in 4 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 7 inclusion and 17 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: finished, as of the sponsor's last update on 15 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States, France, Spain, Switzerland. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incidence of adverse events as a measure of safety (time frame: From time of informed consent through treatment period and including the follow-up 12 weeks after last dose of investigational product, approximately 7 months). The study lists 3 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 15 Aug 2022.