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

Sponsor
AstraZeneca
Study ID
NCT01938612
Phase
PHASE1
Status
Completed

Conditions

  • Advanced Solid Tumors

Eligibility Criteria

Sex
ALL
Age
20 Years - 130 Years
Healthy Volunteers
Not accepted

Interventions

  • MEDI4736 — DRUG
    MEDI4736 will be administered by IV infusion every 14, 21 or 28 days.
  • tremelimumab — DRUG
    tremelimumab is administered by IV infusion every 4 weeks

Study Details

This is a phase I, open-label, multicentre study of MEDI4736 administered intravenously with a standard 3+3 dose-escalation phase to evaluate safety, tolerability, and pharmacokinetics in patients with advanced solid tumor followed by an expansion phase in patients with advanced solid tumors.

Key Dates

Start date
Sep 12, 2013
Status verified
Mar 2021
Primary completion
Mar 1, 2018
Completion
Nov 25, 2020

Study Design

Enrollment
269 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: MEDI4736 Q2W
    Evaluate MEDI4736 given every 2 weeks
  • Experimental: MEDI4736 Q3W
    Evaluate MEDI4736 given every 3 weeks
  • Experimental: MEDI4736 Dose Expansion
    evaluate MEDI4736 given every 2 weeks
  • Experimental: MEDI4736 Q4W
    Evaluate MEDI4736 given every 4 weeks
  • Experimental: MEDI4736 combined with another drug
    evaluate MEDI4736 in combination with another drug given every 4 weeks

Primary Outcome Measure

Number of participants experiencing dose-limiting toxicities, adverse events (AEs), serious adverse events (SAEs) [ Time Frame: 90 days after the last dose of MEDI4736 ]

Related Studies