Phase I/Ib Multiple Ascending Dose Study in China

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Merck KGaA (EMD Serono)

Status and phase

Completed
Phase 1

Conditions

Metastatic Solid Tumors

Treatments

Drug: Avelumab 10 mg/kg Q2W
Drug: Avelumab 3 mg/kg Q2W
Drug: Avelumab 10 mg/kg QW
Drug: Avelumab 20 mg/kg Q2W

Study type

Interventional

Funder types

Industry

Identifiers

NCT03523390
MS100070_0035

Details and patient eligibility

About

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

Enrollment

24 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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
  • Other protocol defined inclusion criteria could apply

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)
  • Other protocol defined exclusion criteria could apply

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Sequential Assignment

Masking

None (Open label)

24 participants in 4 patient groups

Avelumab 3 mg/kg Q2W
Experimental group
Treatment:
Drug: Avelumab 3 mg/kg Q2W
Avelumab 10 mg/kg Q2W
Experimental group
Treatment:
Drug: Avelumab 10 mg/kg Q2W
Avelumab 20 mg/kg Q2W
Experimental group
Treatment:
Drug: Avelumab 20 mg/kg Q2W
Avelumab 10 mg/kg QW
Experimental group
Treatment:
Drug: Avelumab 10 mg/kg QW

Trial documents
2

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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