A Phase I, Open-Label, Multicentre Study to Evaluate the Safety, Tolerability and Pharmacokinetics of MEDI4736 in Patients With Advanced Solid Tumors
- Conditions
- Advanced Solid Tumors
- Registration Number
- JPRN-jRCT2080222260
- Lead Sponsor
- AstraZeneca KK
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 200
In the dose-escalation phase: patients with advanced solid tumors refractory to standard treatment, intolerant of standard treatment, or for which no standard therapy exists.
- In the dose-expansion phase: histologically - or cytologically-confirmed advanced or metastatic biliary tract cancer (BTC), esophagus cancer(EC) (squamous cell carcinoma) or squamous cell carcinoma of the head and neck (SCCHN).
- Eastern Cooperative Oncology Group (ECOG) status of 0 or 1.
- Adequate organ and marrow function.
- Subjects must have at least 1 measurable lesion.
- Available archived tumor tissue sample.
- Willingness to provide consent for biopsy samples.
-Any prior Grade 3 irAE or more while receiving immunotherapy
-Prior exposure to any anti-PD-1 or anti-PD-L1 antibody
-Active or prior documented autoimmune disease within the past 2 years
-History of primary immunodeficiency
-Symptomatic or untreated central nervous system (CNS) metastases requiring concurrent treatment
-Women who are pregnant or lactating
-Uncontrolled intercurrent illness
-Known history of tuberculosis
-Known to be human immunodeficiency virus (HIV) positive
-Active infection including hepatitis B or hepatitis C
-Other invasive malignancy within 5 years
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method efficacy<br>-
- Secondary Outcome Measures
Name Time Method safety<br>pharmacokinetics<br>-