A Phase I, Open-Label, Multicentre Study to Evaluate the Safety, Tolerability and Pharmacokinetics of MEDI4736 in Patients With Advanced Solid Tumors

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080222260

Enrollment

200

Registered

2013-10-23

Start date

2013-09-12

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Solid Tumors

Interventions

investigational material(s) Generic name etc : MEDI4736, tremelimumab INN of investigational material : - Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investiga

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - 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.

Exclusion criteria

Exclusion criteria: -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

Design outcomes

Primary

Measure	Time frame
efficacy -	—

Secondary

Measure	Time frame
safety pharmacokinetics -	—

Countries

Asia except Japan, Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026