Clinical Trials /

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

NCT04261075

Description:

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.

Related Conditions:
  • Malignant Solid Tumor
  • Pancreatic Ductal Adenocarcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

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

Clinical Trial IDs

  • ORG STUDY ID: D6770C00001
  • NCT ID: NCT04261075

Conditions

  • Advanced Solid Tumors

Interventions

DrugSynonymsArms
IPH5201IPH5201 dose escalation with durvalumab
durvalumabIPH5201 dose escalation with durvalumab
oleclumabIPH5201 dose escalation with durvalumab + oleclumab

Purpose

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.
    

Trial Arms

NameTypeDescriptionInterventions
IPH5201 monotherapy dose escalationExperimentalIPH5201 monotherapy
  • IPH5201
IPH5201 dose escalation with durvalumabExperimentalIPH5201 plus durvalumab
  • IPH5201
  • durvalumab
IPH5201 dose escalation with durvalumab + oleclumabExperimentalIPH5201 plus durvalumab and oleclumab
  • IPH5201
  • durvalumab
  • oleclumab

Eligibility 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
      
Maximum Eligible Age:101 Years
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

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
Safety Issue:
Description:The primary endpoint is safety as assessed by the presence of adverse events (AEs), serious adverse events (SAEs), and dose limiting toxicities (DLTs).

Secondary Outcome Measures

Measure: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)
Safety Issue:
Description:Evaluate the primary antitumor activity of IPH5201 monotherapy or in combination with durvalumab +/- oleclumab (disease control)
Measure:DC (Disease Control; RECIST 1.1)
Time Frame:From time of consent until date of first documented disease progression (approximately 4 months)
Safety Issue:
Description:Evaluate the primary antitumor activity of IPH5201 with durvalumab +/- oleclumab (disease control)
Measure:Half-life of IPH5201
Time Frame:From start of treatment through Cycle 6 (21 day cycle, approximately 5 months)
Safety Issue:
Description:To characterize the pharmacokinetics of IPH5201 as monotherapy and in combination with durvalumab ± oleclumab
Measure:Maximum serum concentration (Cmax) of IPH5201
Time Frame:From start of treatment through Cycle 6 (21 day cycle, approximately 5 months)
Safety Issue:
Description:To characterize the pharmacokinetics of IPH5201 as monotherapy and in combination with durvalumab ± oleclumab
Measure:Area under the curve (AUC) of IPH5201
Time Frame:From start of treatment through Cycle 6 (21 day cycle, approximately 5 months)
Safety Issue:
Description:To characterize the pharmacokinetics of IPH5201 as monotherapy and in combination with durvalumab ± oleclumab
Measure:Serum trough concentrations (durvalumab)
Time Frame:From start of treatment through Cycle 6 (21 day cycle, approximately 5 months)
Safety Issue:
Description:To determine the pharmacokinetics of durvalumab when administered in combination with IPH5201+/- oleclumab
Measure:Serum trough concentrations (oleclumab)
Time Frame:From start of treatment through Cycle 6 (21 day cycle, approximately 5 months)
Safety Issue:
Description:To determine the pharmacokinetics of oleclumab in combination with durvalumab and IPH5201
Measure:Incidence of antidrug antibodies (IPH5201)
Time Frame:From start of treatment until 90 days after end of treatment (approximately 7 months)
Safety Issue:
Description:To determine the immunogenicity of IPH5201 as monotherapy and in combination with durvalumab ± oleclumab
Measure:Incidence of antidrug antibodies (durvalumab)
Time Frame:From start of treatment until 90 days after end of treatment (approximately 7 months)
Safety Issue:
Description:To determine the immunogenicity of durvalumab in combination with IPH5201 ± oleclumab
Measure:Incidence of antidrug antibodies (oleclumab)
Time Frame:From start of treatment until 90 days after end of treatment (approximately 7 months)
Safety Issue:
Description:To determine the immunogenicity of oleclumab in combination with IPH5201 + durvalumab

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:MedImmune LLC

Last Updated

February 6, 2020