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Phase Ia/Ib Multicenter Trial of Mogamulizumab for Advanced or Recurrent Cancer.

Primary Purpose

Solid Tumor

Status

Unknown status

Phase

Phase 1

Locations

Japan

Study Type

Interventional

Intervention

Mogamulizumab

About this trial

This is an interventional treatment trial for Solid Tumor

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients with histologically confirmed, CCR4 negative lung, stomach, esophageal, ovarian or skin cancer.
Patients with therapy-resistant cancer. Patients with recurrent cancer or advanced cancer who refused standard therapies.
Eastern Cooperative Oncology Group (ECOG) Performance Status is 0, 1 or 2.
Patients should be 20 years or older at the time of informed consent.
No serious dysfunction of major organs (bone marrow, heart, lung, liver and kidney) and meet the following conditions ; 1) WBC count : >=1,500/mm3 2) Hemoglobin : >=8.0g/dL 3) Platelet count : >=75,000/mm3 4) Serum total bilirubin : <=2.0 x ULN 5) AST and ALT : <=2.5 x ULN (Patients with hepatic infiltration which is attributed to primary disease<=5.0 x ULN) 6) Serum creatinine : <=1.5 mg/dL 7) SpO2 : >=93 % 8) ECG : No abnormal findings. 9) EF : >=50 %
Agree to use birth control including condom etc. from the time of obtaining the first consent to 24 weeks after the final administration of the study drug (except female after menopause (1 year or more after the last menstruation) and female/male after the operation for sterilization).
Given written informed consent.
Patients who can be hospitalized from the day of first administration to the next day.
Patients who have target lesions measurable by RECIST ver.1.1.
Life expectancy >= 3 months.

Exclusion Criteria:

Patients with HIV antibody positive.
Patients with HCV antibody positive.
Patients with autoimmune disease.
Patients with HBs antigen or HBV-DNA positive.
History of serious anaphylaxis induced by antibody preparation.
Patients with double cancer.
Within 4 weeks after treatment with anticancer agent, immune suppressant, immune enhancer, cytokine therapy, radiotherapy or surgery for the primary disease.
Pregnant or breast-feeding females and females who have a possibility of pregnancy.
Patients with active infection.
Patients with psychosis or dementia.
Patients who need continuous systemic administration of adrenocorticosteroid.
Patients who have received hematopoietic stem cell transplantation.
Patients who have presence or suspicion of CNS involvement.
Patients who are administered the other investigational product within 4 weeks of the entry.
Patients treated with immunotherapy for cancer (e.g. cancer vaccine therapy) within 12 weeks of the entry.
Any other inadequacy for this study.

Sites / Locations

Aichi Medical University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

<Phase Ia> Mogamulizumab 0.1mg/kg, 0.5mg/kg or 1.0mg/kg

<Phase Ib> Mogamulizumab of the tolerated dose

<Phase Ib> Mogamulizumab 0.1mg/kg

Arm Description

<Phase Ia> Dose-escalation method with Mogamulizumab 0.1mg/kg, 0.5mg/kg or 1.0mg/kg. Mogamulizumab will be administered 8 times every week.

<Phase Ib> Mogamulizumab of the tolerated dose in Phase Ia will be administered 8 times every week.

<Phase Ib> Mogamulizumab 0.1mg/kg will be administered 8 times every week.

Outcomes

Primary Outcome Measures

Maximum tolerated dose(MTD) of Mogamulizumab

Dose limiting toxicity(DLT) of Mogamulizumab

Number of adverse events

Cmax of Mogamulizumab

Ctrough of Mogamulizumab

AUC0-7day of Mogamulizumab

Rate of Treg decrease in PBMC compared to baseline

Secondary Outcome Measures

Objective tumor response rate according to RECIST

Median progression free survival rate

Median Overall survival rate

Full Information

NCT ID

NCT01929486

First Posted

July 24, 2013

Last Updated

February 16, 2016

Sponsor

Aichi Medical University

1. Study Identification

Unique Protocol Identification Number

NCT01929486

Brief Title

Phase Ia/Ib Multicenter Trial of Mogamulizumab for Advanced or Recurrent Cancer.

Official Title

Phase Ia/Ib Multicenter Trial of Mogamulizumab for Advanced or Recurrent Cancer.

Study Type

Interventional

2. Study Status

Record Verification Date

February 2016

Overall Recruitment Status

Unknown status

Study Start Date

February 2013 (undefined)

Primary Completion Date

June 2016 (Anticipated)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Aichi Medical University

4. Oversight

5. Study Description

Brief Summary

The purpose of this study is to investigate safety, pharmacokinetics, effect of regulatory T cell depletion with Mogamulizumab for advanced or recurrent cancer patients.

Detailed Description

This study consists of phase Ia and Ib portions for patients with solid tumors. Phase Ia portion is the standard 3+3 dose-escalation design with 0.1mg/kg, 0.5mg/kg and 1.0mg/kg of Mogamulizumab. Phase Ib portion is the randomized study comparing 0.1mg/kg and tolerated dose of Mogamulizumab based on the phase Ia portion to pursue safer and immunologically more efficient dose.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Solid Tumor

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

58 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

<Phase Ia> Mogamulizumab 0.1mg/kg, 0.5mg/kg or 1.0mg/kg

Arm Type

Experimental

Arm Description

<Phase Ia> Dose-escalation method with Mogamulizumab 0.1mg/kg, 0.5mg/kg or 1.0mg/kg. Mogamulizumab will be administered 8 times every week.

Arm Title

<Phase Ib> Mogamulizumab of the tolerated dose

Arm Type

Experimental

Arm Description

<Phase Ib> Mogamulizumab of the tolerated dose in Phase Ia will be administered 8 times every week.

Arm Title

<Phase Ib> Mogamulizumab 0.1mg/kg

Arm Type

Experimental

Arm Description

<Phase Ib> Mogamulizumab 0.1mg/kg will be administered 8 times every week.

Intervention Type

Biological

Intervention Name(s)

Mogamulizumab

Other Intervention Name(s)

KW-0761

Intervention Description

Mogamulizumab 0.1mg/kg, 0.5mg/kg or 1.0mg/kg will be administered 8 times every week.

Primary Outcome Measure Information:

Title

Maximum tolerated dose(MTD) of Mogamulizumab

Time Frame

from first administration until day 28

Title

Dose limiting toxicity(DLT) of Mogamulizumab

Time Frame

from first administration until day 28

Title

Number of adverse events

Time Frame

from first administration to 24 weeks after the final administration, an expected average of 32 weeks.

Title

Cmax of Mogamulizumab

Time Frame

from day 0 to 28 days after the final administration, an expected average of 12 weeks.

Title

Ctrough of Mogamulizumab

Time Frame

from day 0 to 28 days after the final administration, an expected average of 12 weeks.

Title

AUC0-7day of Mogamulizumab

Time Frame

from day 0 to 28 days after the final administration, an expected average of 12 weeks.

Title

Rate of Treg decrease in PBMC compared to baseline

Time Frame

from baseline to every 4 weeks until data cut off

Secondary Outcome Measure Information:

Title

Objective tumor response rate according to RECIST

Time Frame

from baseline to every 12 weeks, until data cut off

Title

Median progression free survival rate

Time Frame

from baseline to every 12 weeks, until data cut off (expected date is March 2016)

Title

Median Overall survival rate

Time Frame

from baseline to every 12 weeks, until data cut off

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients with histologically confirmed, CCR4 negative lung, stomach, esophageal, ovarian or skin cancer. Patients with therapy-resistant cancer. Patients with recurrent cancer or advanced cancer who refused standard therapies. Eastern Cooperative Oncology Group (ECOG) Performance Status is 0, 1 or 2. Patients should be 20 years or older at the time of informed consent. No serious dysfunction of major organs (bone marrow, heart, lung, liver and kidney) and meet the following conditions ; 1) WBC count : >=1,500/mm3 2) Hemoglobin : >=8.0g/dL 3) Platelet count : >=75,000/mm3 4) Serum total bilirubin : <=2.0 x ULN 5) AST and ALT : <=2.5 x ULN (Patients with hepatic infiltration which is attributed to primary disease<=5.0 x ULN) 6) Serum creatinine : <=1.5 mg/dL 7) SpO2 : >=93 % 8) ECG : No abnormal findings. 9) EF : >=50 % Agree to use birth control including condom etc. from the time of obtaining the first consent to 24 weeks after the final administration of the study drug (except female after menopause (1 year or more after the last menstruation) and female/male after the operation for sterilization). Given written informed consent. Patients who can be hospitalized from the day of first administration to the next day. Patients who have target lesions measurable by RECIST ver.1.1. Life expectancy >= 3 months. Exclusion Criteria: Patients with HIV antibody positive. Patients with HCV antibody positive. Patients with autoimmune disease. Patients with HBs antigen or HBV-DNA positive. History of serious anaphylaxis induced by antibody preparation. Patients with double cancer. Within 4 weeks after treatment with anticancer agent, immune suppressant, immune enhancer, cytokine therapy, radiotherapy or surgery for the primary disease. Pregnant or breast-feeding females and females who have a possibility of pregnancy. Patients with active infection. Patients with psychosis or dementia. Patients who need continuous systemic administration of adrenocorticosteroid. Patients who have received hematopoietic stem cell transplantation. Patients who have presence or suspicion of CNS involvement. Patients who are administered the other investigational product within 4 weeks of the entry. Patients treated with immunotherapy for cancer (e.g. cancer vaccine therapy) within 12 weeks of the entry. Any other inadequacy for this study.

Facility Information:

Facility Name

Aichi Medical University

City

Nagoya

State/Province

Aichi

Country

Japan

12. IPD Sharing Statement

Citations:

PubMed Identifier

34907192

Citation

Maeda Y, Wada H, Sugiyama D, Saito T, Irie T, Itahashi K, Minoura K, Suzuki S, Kojima T, Kakimi K, Nakajima J, Funakoshi T, Iida S, Oka M, Shimamura T, Doi T, Doki Y, Nakayama E, Ueda R, Nishikawa H. Depletion of central memory CD8+ T cells might impede the antitumor therapeutic effect of Mogamulizumab. Nat Commun. 2021 Dec 14;12(1):7280. doi: 10.1038/s41467-021-27574-0.

Results Reference

derived

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Phase Ia/Ib Multicenter Trial of Mogamulizumab for Advanced or Recurrent Cancer.

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