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

  • STATUS
    Recruiting
  • End date
    Feb 20, 2023
  • participants needed
    204
  • sponsor
    MedImmune LLC
Updated on 26 July 2021

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.

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.

Details
Condition Advanced Solid Tumors
Treatment durvalumab, oleclumab, IPH5201
Clinical Study IdentifierNCT04261075
SponsorMedImmune LLC
Last Modified on26 July 2021

Eligibility

Yes No Not Sure

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
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