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NCT Number: NCT01938612

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

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.

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Key information

Conditions

Advanced Solid Tumors Biliary Tract Diseases Biliary Tract Neoplasms Carcinoma Carcinoma, Squamous Cell Digestive System Diseases Digestive System Neoplasms Head and Neck Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Squamous Cell Carcinoma of Head and Neck

Age range

20 year–130 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site, Beppu-shi, Japan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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). - men or women. - 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

  • Any prior Grade ≥ 3 irAE 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 - Hepatitis B or C infection - Other invasive malignancy within 5 years

Treatment and study plan

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

Primary outcomes

  1. Number of participants experiencing dose-limiting toxicities, adverse events (AEs), serious adverse events (SAEs)

    Time frame: 90 days after the last dose of MEDI4736

    Safety profile will be assessed through number of participants experiencing adverse events (AEs), serious adverse events (SAEs), laboratory evaluations, vital signs, and physical examinations.

Secondary outcomes

  1. Area under the concentration of MEDI4736 time curve

    Time frame: Up to 90 days after the last dose of MEDI4736

    If data allow, noncompartmental PK parameter (AUC) will be estimated.

  2. Percentage of participants who developed detectable anti-drug antibodies (ADAs).

    Time frame: Up to 6 months after the last dose of MEDI4736 or up to 1 month after the last dose of tremelimumab where applicable.

    The immunogenic potential of MEDI4736 or tremelimumab will be assessed by summarizing the number percentage of subjects who develop detectable anti-drug antibodies (ADAs).

  3. Objective response rate (ORR)

    Time frame: From first dose of study drug until death or up to 2 years

  4. Maximum tolerated dose (MTD) or optimal biological dose (OBD)

    Time frame: 90 days after the last dose of MEDI4736

    maximum tolerated dose (MTD) or optimal biological dose (OBD) of MEDI4736, if possible

  5. Maximum concentration of MEDI4736

    Time frame: Up to 90 days after the last dose of MEDI4736

    If data allow, noncompartmental PK parameter (Cmax) will be estimated.

  6. Clearance

    Time frame: Up to 90 days after the last dose of MEDI4736

    If data allow, noncompartmental PK parameter (CL) will be estimated.

  7. half-life after administration of MEDI4736

    Time frame: Up to 90 days after the last dose of MEDI4736

    If data allow, noncompartmental PK parameter (t½) will be estimated.

  8. Disease control rate (DCR)

    Time frame: From first dose of study drug until death or up to 2 years

  9. Duration of response (DoR)

    Time frame: From first dose of study drug until death or up to 2 years

  10. Progression-free survival (PFS)

    Time frame: From first dose of study drug until death or up to 2 years

    Alive and progression free at 6 months (APF6) and 12 months (APF12) will be obtained using the Kaplan-Meier plot of PFS.

  11. Overall survival (OS)

    Time frame: From first dose of study drug until death or up to 2 years

    The proportion of patients alive at 12 months will be obtained from the Kaplan-Meier plot of OS.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Important dates

Study start
2013
Primary completion
2018
Study completion
2020
First posted
Sep 10, 2013
Registry last updated
Mar 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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