IPH5201 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