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

Solid Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01929486
• Other study ID #: KW0761-IIT-01
• Status: Active, not recruiting
• Phase: Phase 1
• First received: July 24, 2013
• Last updated: February 16, 2016
• Start date: February 2013

Study information

• Verified date: February 2016
• Source: Aichi Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 58
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

1. Patients with histologically confirmed, CCR4 negative lung, stomach, esophageal, ovarian or skin cancer.

2. Patients with therapy-resistant cancer. Patients with recurrent cancer or advanced cancer who refused standard therapies.

3. Eastern Cooperative Oncology Group (ECOG) Performance Status is 0, 1 or 2.

4. Patients should be 20 years or older at the time of informed consent.

5. 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 %

6. 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).

7. Given written informed consent.

8. Patients who can be hospitalized from the day of first administration to the next day.

9. Patients who have target lesions measurable by RECIST ver.1.1.

10. Life expectancy >= 3 months.

Exclusion Criteria:

1. Patients with HIV antibody positive.

2. Patients with HCV antibody positive.

3. Patients with autoimmune disease.

4. Patients with HBs antigen or HBV-DNA positive.

5. History of serious anaphylaxis induced by antibody preparation.

6. Patients with double cancer.

7. Within 4 weeks after treatment with anticancer agent, immune suppressant, immune enhancer, cytokine therapy, radiotherapy or surgery for the primary disease.

8. Pregnant or breast-feeding females and females who have a possibility of pregnancy.

9. Patients with active infection.

10. Patients with psychosis or dementia.

11. Patients who need continuous systemic administration of adrenocorticosteroid.

12. Patients who have received hematopoietic stem cell transplantation.

13. Patients who have presence or suspicion of CNS involvement.

14. Patients who are administered the other investigational product within 4 weeks of the entry.

15. Patients treated with immunotherapy for cancer (e.g. cancer vaccine therapy) within 12 weeks of the entry.

16. Any other inadequacy for this study.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Recurrence
• Solid Tumor

Intervention

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

Locations

Country	Name	City	State
Japan	Aichi Medical University	Nagoya	Aichi

Sponsors (1)

Lead Sponsor	Collaborator
Aichi Medical University

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum tolerated dose(MTD) of Mogamulizumab		from first administration until day 28	Yes
Primary	Dose limiting toxicity(DLT) of Mogamulizumab		from first administration until day 28	Yes
Primary	Number of adverse events		from first administration to 24 weeks after the final administration, an expected average of 32 weeks.	Yes
Primary	Cmax of Mogamulizumab		from day 0 to 28 days after the final administration, an expected average of 12 weeks.	No
Primary	Ctrough of Mogamulizumab		from day 0 to 28 days after the final administration, an expected average of 12 weeks.	No
Primary	AUC0-7day of Mogamulizumab		from day 0 to 28 days after the final administration, an expected average of 12 weeks.	No
Primary	Rate of Treg decrease in PBMC compared to baseline		from baseline to every 4 weeks until data cut off	No
Secondary	Objective tumor response rate according to RECIST		from baseline to every 12 weeks, until data cut off	No
Secondary	Median progression free survival rate		from baseline to every 12 weeks, until data cut off (expected date is March 2016)	No
Secondary	Median Overall survival rate		from baseline to every 12 weeks, until data cut off	No