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

NCT01929486 | Unknown Phase 1

• 1 other identifier: KW0761-IIT-01
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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.

Conditions

Solid Tumor

Outcome Measures

Primary Outcomes (7)

• Maximum tolerated dose(MTD) of Mogamulizumab

  from first administration until day 28

• Dose limiting toxicity(DLT) of Mogamulizumab

  from first administration until day 28

• Number of adverse events

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

• Cmax of Mogamulizumab

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

• Ctrough of Mogamulizumab

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

• AUC0-7day of Mogamulizumab

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

• Rate of Treg decrease in PBMC compared to baseline

  from baseline to every 4 weeks until data cut off

Secondary Outcomes (3)

• Objective tumor response rate according to RECIST

  from baseline to every 12 weeks, until data cut off

• Median progression free survival rate

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

• Median Overall survival rate

  from baseline to every 12 weeks, until data cut off

Study Arms (3)

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

EXPERIMENTAL

\<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.

Biological: Mogamulizumab

<Phase Ib> Mogamulizumab of the tolerated dose

EXPERIMENTAL

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

Biological: Mogamulizumab

<Phase Ib> Mogamulizumab 0.1mg/kg

EXPERIMENTAL

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

Biological: Mogamulizumab

Interventions

Mogamulizumab BIOLOGICAL

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

Also known as: KW-0761

<Phase Ia> Mogamulizumab 0.1mg/kg, 0.5mg/kg or 1.0mg/kg; <Phase Ib> Mogamulizumab 0.1mg/kg; <Phase Ib> Mogamulizumab of the tolerated dose

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aichi Medical University: lead

Study Sites (1)

Aichi Medical University

Nagoya, Aichi-ken, Japan

Location

Related Publications (2)

• Fujikawa K, Saito T, Kurose K, Kojima T, Funakoshi T, Sato E, Kakimi K, Iida S, Doki Y, Oka M, Ueda R, Wada H. Integrated analysis of phase 1a and 1b randomized controlled trials; Treg-targeted cancer immunotherapy with the humanized anti-CCR4 antibody, KW-0761, for advanced solid tumors. PLoS One. 2023 Sep 20;18(9):e0291772. doi: 10.1371/journal.pone.0291772. eCollection 2023.

  PMID: 37729184 DERIVED

• 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.

  PMID: 34907192 DERIVED

MeSH Terms

Interventions

mogamulizumab

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Aichi Medical University

Study Record Dates

• First Submitted: July 24, 2013
• First Posted: August 28, 2013
• Study Start: February 1, 2013
• Primary Completion: June 1, 2016
• Last Updated: February 17, 2016

Record last verified: 2016-02

Locations

JP (1)