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

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: NCT04261075
Recruitment Status : Completed
First Posted : February 7, 2020
Last Update Posted : August 15, 2022
Sponsor:
Information provided by (Responsible Party):
MedImmune LLC

Tracking Information
First Submitted Date  ICMJE January 7, 2020
First Posted Date  ICMJE February 7, 2020
Last Update Posted Date August 15, 2022
Actual Study Start Date  ICMJE March 3, 2020
Actual Primary Completion Date June 16, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 6, 2020)
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 6, 2020)
  • 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)
  • 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)
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
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 IPH5201 as Monotherapy or in Combination With Durvalumab +/- Oleclumab in Subjects With Advanced Solid Tumors.
Official Title  ICMJE 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
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.
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 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: 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
Study Arms  ICMJE
  • Experimental: IPH5201 monotherapy dose escalation
    IPH5201 monotherapy
    Intervention: Biological: IPH5201
  • Experimental: IPH5201 dose escalation with durvalumab
    IPH5201 plus durvalumab
    Interventions:
    • Biological: IPH5201
    • Biological: durvalumab
  • Experimental: IPH5201 dose escalation with durvalumab + oleclumab
    IPH5201 plus durvalumab and oleclumab
    Interventions:
    • Biological: IPH5201
    • Biological: durvalumab
    • Biological: oleclumab
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 Completed
Actual Enrollment  ICMJE
 (submitted: November 8, 2021)
57
Original Estimated Enrollment  ICMJE
 (submitted: February 6, 2020)
204
Actual Study Completion Date  ICMJE June 16, 2022
Actual Primary Completion Date June 16, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 101 Years   (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,   Spain,   Switzerland,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04261075
Other Study ID Numbers  ICMJE D6770C00001
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party MedImmune LLC
Original Responsible Party Same as current
Current Study Sponsor  ICMJE MedImmune LLC
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account MedImmune LLC
Verification Date August 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP