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IPH5201 as Monotherapy or in Combination With Durvalumab +/- Oleclumab in Subjects With Advanced Solid Tumors

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ClinicalTrials.gov Identifier: NCT04261075
Recruitment Status : Recruiting
First Posted : February 7, 2020
Last Update Posted : March 13, 2020
Sponsor:
Information provided by (Responsible Party):
MedImmune LLC

Brief 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.

Condition or disease Intervention/treatment Phase
Advanced Solid Tumors Biological: IPH5201 Biological: durvalumab Biological: oleclumab Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 204 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : March 3, 2020
Estimated Primary Completion Date : August 24, 2022
Estimated Study Completion Date : August 24, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Durvalumab

Arm Intervention/treatment
Experimental: IPH5201 monotherapy dose escalation
IPH5201 monotherapy
Biological: IPH5201
Ascending dose levels of IPH5201 every 3 weeks (Q3W) for a maximum of 2 years

Experimental: IPH5201 dose escalation with durvalumab
IPH5201 plus durvalumab
Biological: IPH5201
Ascending dose levels of IPH5201 every 3 weeks (Q3W) for a maximum of 2 years

Biological: durvalumab
Durvalumab Q3W for a maximum of 2 years

Experimental: IPH5201 dose escalation with durvalumab + oleclumab
IPH5201 plus durvalumab and oleclumab
Biological: IPH5201
Ascending dose levels of IPH5201 every 3 weeks (Q3W) for a maximum of 2 years

Biological: durvalumab
Durvalumab Q3W for a maximum of 2 years

Biological: oleclumab
Oleclumab Q3W for a maximum of 2 years




Primary Outcome Measures :
  1. 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).

  2. 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.

  3. 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


Secondary Outcome Measures :
  1. 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) ]
    Evaluate the primary antitumor activity of IPH5201 monotherapy or in combination with durvalumab +/- oleclumab (disease control)

  2. DC (Disease Control; RECIST 1.1) [ Time Frame: From time of consent until date of first documented disease progression (approximately 4 months) ]
    Evaluate the primary antitumor activity of IPH5201 with durvalumab +/- oleclumab (disease control)

  3. Half-life of IPH5201 [ Time Frame: From start of treatment through Cycle 6 (21 day cycle, approximately 5 months) ]
    To characterize the pharmacokinetics of IPH5201 as monotherapy and in combination with durvalumab ± oleclumab

  4. Maximum serum concentration (Cmax) of IPH5201 [ Time Frame: From start of treatment through Cycle 6 (21 day cycle, approximately 5 months) ]
    To characterize the pharmacokinetics of IPH5201 as monotherapy and in combination with durvalumab ± oleclumab

  5. Area under the curve (AUC) of IPH5201 [ Time Frame: From start of treatment through Cycle 6 (21 day cycle, approximately 5 months) ]
    To characterize the pharmacokinetics of IPH5201 as monotherapy and in combination with durvalumab ± oleclumab

  6. Serum trough concentrations (durvalumab) [ Time Frame: From start of treatment through Cycle 6 (21 day cycle, approximately 5 months) ]
    To determine the pharmacokinetics of durvalumab when administered in combination with IPH5201+/- oleclumab

  7. Serum trough concentrations (oleclumab) [ Time Frame: From start of treatment through Cycle 6 (21 day cycle, approximately 5 months) ]
    To determine the pharmacokinetics of oleclumab in combination with durvalumab and IPH5201

  8. Incidence of antidrug antibodies (IPH5201) [ Time Frame: From start of treatment until 90 days after end of treatment (approximately 7 months) ]
    To determine the immunogenicity of IPH5201 as monotherapy and in combination with durvalumab ± oleclumab

  9. Incidence of antidrug antibodies (durvalumab) [ Time Frame: From start of treatment until 90 days after end of treatment (approximately 7 months) ]
    To determine the immunogenicity of durvalumab in combination with IPH5201 ± oleclumab

  10. Incidence of antidrug antibodies (oleclumab) [ Time Frame: From start of treatment until 90 days after end of treatment (approximately 7 months) ]
    To determine the immunogenicity of oleclumab in combination with IPH5201 + durvalumab



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 101 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 .

Exclusion Criteria:

  • 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
  • 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

Information from the National Library of Medicine

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): NCT04261075


Contacts
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Contact: AstraZeneca Clinical Study Information Center 1-877-240-9479 information.center@astrazeneca.com

Locations
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United States, North Carolina
Research Site Recruiting
Huntersville, North Carolina, United States, 28078
United States, Rhode Island
Research Site Not yet recruiting
Providence, Rhode Island, United States, 02906
United States, Tennessee
Research Site Not yet recruiting
Nashville, Tennessee, United States, 37203
France
Research Site Not yet recruiting
Bordeaux Cedex, France, 33076
Research Site Not yet recruiting
Villejuif, France, 94805
Switzerland
Research Site Not yet recruiting
Lausanne, Switzerland, 1011
Sponsors and Collaborators
MedImmune LLC

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Responsible Party: MedImmune LLC
ClinicalTrials.gov Identifier: NCT04261075    
Other Study ID Numbers: D6770C00001
First Posted: February 7, 2020    Key Record Dates
Last Update Posted: March 13, 2020
Last Verified: March 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms
Durvalumab
Antibodies, Monoclonal
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs