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

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.

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.

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