Phase I/Ib Multiple Ascending Dose Study in China

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-24

Study Completion Date

2021-02-08

Brief Summary

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The purpose of this study was to evaluate the maximum tolerated dose (MTD) and pharmacokinetics (PK) of Avelumab monotherapy in Chinese subjects.

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Detailed Description

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Conditions

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Metastatic Solid Tumors

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Subsequent cohorts of subjects treated at different dose levels in this study.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Avelumab 3 mg/kg Q2W

Group Type EXPERIMENTAL

Avelumab 3 mg/kg Q2W

Intervention Type DRUG

Participants received intravenous infusion of Avelumab over 1 hour duration at a dose of 3 milligrams per kilogram (mg/kg) once every 2 weeks (Q2W) until disease progression, significant clinical deterioration, unacceptable toxicity, or any criterion for withdrawal from the study or from Avelumab occurs.

Avelumab 10 mg/kg Q2W

Group Type EXPERIMENTAL

Avelumab 10 mg/kg Q2W

Intervention Type DRUG

Participants received intravenous infusion of Avelumab over 1 hour duration at a dose of 10 mg/kg Q2W until disease progression, significant clinical deterioration, unacceptable toxicity, or any criterion for withdrawal from the study or from Avelumab occurs.

Avelumab 20 mg/kg Q2W

Group Type EXPERIMENTAL

Avelumab 20 mg/kg Q2W

Intervention Type DRUG

Participants received intravenous infusion of Avelumab over 1 hour duration at a dose of 20 mg/kg Q2W until disease progression, significant clinical deterioration, unacceptable toxicity, or any criterion for withdrawal from the study or from Avelumab occurs.

Avelumab 10 mg/kg QW

Group Type EXPERIMENTAL

Avelumab 10 mg/kg QW

Intervention Type DRUG

Participants received intravenous infusion of Avelumab over 1 hour duration at a dose of 10 mg/kg every week (QW) for the first 12 weeks followed by once every 2 weeks, started at Week 13 until disease progression, significant clinical deterioration, unacceptable toxicity, or any criterion for withdrawal from the study or from Avelumab occurs.

Interventions

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Avelumab 3 mg/kg Q2W

Participants received intravenous infusion of Avelumab over 1 hour duration at a dose of 3 milligrams per kilogram (mg/kg) once every 2 weeks (Q2W) until disease progression, significant clinical deterioration, unacceptable toxicity, or any criterion for withdrawal from the study or from Avelumab occurs.

Intervention Type DRUG

Avelumab 10 mg/kg Q2W

Participants received intravenous infusion of Avelumab over 1 hour duration at a dose of 10 mg/kg Q2W until disease progression, significant clinical deterioration, unacceptable toxicity, or any criterion for withdrawal from the study or from Avelumab occurs.

Intervention Type DRUG

Avelumab 20 mg/kg Q2W

Participants received intravenous infusion of Avelumab over 1 hour duration at a dose of 20 mg/kg Q2W until disease progression, significant clinical deterioration, unacceptable toxicity, or any criterion for withdrawal from the study or from Avelumab occurs.

Intervention Type DRUG

Avelumab 10 mg/kg QW

Participants received intravenous infusion of Avelumab over 1 hour duration at a dose of 10 mg/kg every week (QW) for the first 12 weeks followed by once every 2 weeks, started at Week 13 until disease progression, significant clinical deterioration, unacceptable toxicity, or any criterion for withdrawal from the study or from Avelumab occurs.

Intervention Type DRUG

Other Intervention Names

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MSB0010718C

Eligibility Criteria

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Inclusion Criteria

* Signed written informed consent prior to any study-related procedures are undertaken that are not part of standard patient management
* Histologically or cytologically proven locally advanced unresectable or metastatic solid tumors, for which no standard therapy exists or standard therapy has failed
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at study entry
* Availability of a recently obtained formalin-fixed, paraffin-embedded block containing tumor tissue (biopsy from a non-irradiated area within 6 months) or 12 or more unstained tumor slides suitable for biomarker detection

Exclusion Criteria

* Prior therapy with any antibody/drug targeting T-cell coregulatory proteins (immune checkpoints) such as programmed death 1 (PD-1), PD-L1, cytotoxic T-lymphocyte antigen-4 (CTLA-4), 4-1BB, Lymphocyte-activation gene 3 (LAG-3), T-cell immunoglobulin and mucin-domain containing-3 (TIM-3) or anti-Cluster of Differentiation (CD)-127
* Persisting toxicity related to prior therapy (Grade greater than equals to \[\>=\] 2 National Cancer Institute- Common Terminology Criteria for Adverse Events \[NCI-CTCAE\] v4.03, except Grade less than \[\<\] 3 neuropathy and alopecia of any grade)
* Concurrent anticancer treatment (for example, cytoreductive therapy, radiotherapy \[with the exception of limited palliative bone-directed radiotherapy\], immune therapy, or cytokine therapy except for erthyropoietin).
* Concurrent immunosuppressive agents (except for corticosteroids at physiologic replacement dose, equivalent to less than equals to \[\<=\] 10 milligram \[mg\] prednisone daily)
* Severe hypersensitivity reactions to monoclonal antibodies (Grade \>= 3 NCI-CTCAE v4.03)
* Active brain metastases (except those treated locally, and have not been progressing for at least 2 weeks after the completion of therapy, with no steroid maintenance therapy required, and no ongoing neurological symptoms related to brain localization of the disease)
* Any history of anaphylaxis, or uncontrolled asthma (that is, 3 or more features of partially controlled asthma)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No