Solid TumorPhase 1NCT01929486
Phase Ia/Ib Multicenter Trial of Mogamulizumab for Advanced or Recurrent Cancer.
A Phase 1 study testing Mogamulizumab in people with Solid Tumor, run by Aichi Medical University at 1 site in Japan.
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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Solid Tumor
- What is being tested?
- Mogamulizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteJapan
- Study dates
- Feb 2013to Jun 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to investigate safety, pharmacokinetics, effect of regulatory T cell depletion with Mogamulizumab for advanced or recurrent cancer patients.
Read the 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.
- Conditions
- Solid Tumor
- Being tested
- Mogamulizumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MogamulizumabBiological
Also called KW-0761
Mogamulizumab 0.1mg/kg, 0.5mg/kg or 1.0mg/kg will be administered 8 times every week.
| Study group | Role | What they receive |
|---|---|---|
| <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. Receives: 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. Receives: Biological: Mogamulizumab |
| <Phase Ib> Mogamulizumab 0.1mg/kg | Experimental | <Phase Ib> Mogamulizumab 0.1mg/kg will be administered 8 times every week. Receives: Biological: Mogamulizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose(MTD) of Mogamulizumab
Measured: from first administration until day 28
Dose limiting toxicity(DLT) of Mogamulizumab
Measured: from first administration until day 28
Number of adverse events
Measured: from first administration to 24 weeks after the final administration, an expected average of 32 weeks.
Cmax of Mogamulizumab
Measured: from day 0 to 28 days after the final administration, an expected average of 12 weeks.
Ctrough of Mogamulizumab
Measured: from day 0 to 28 days after the final administration, an expected average of 12 weeks.
AUC0-7day of Mogamulizumab
Measured: 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
Measured: from baseline to every 4 weeks until data cut off
Secondary outcomes (3)
Objective tumor response rate according to RECIST
Measured: from baseline to every 12 weeks, until data cut off
Median progression free survival rate
Measured: from baseline to every 12 weeks, until data cut off (expected date is March 2016)
Median Overall survival rate
Measured: from baseline to every 12 weeks, until data cut off
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2013 (estimated)
- Study startFeb 2013
- Primary completionJun 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aichi Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ryuzo Ueda, MD, Aichi Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01929486
- Sponsor's protocol ID
- KW0761-IIT-01
- Status last verified
- Feb 2016
- First submitted
- 24 Jul 2013
- Last updated
- 17 Feb 2016
- Results posted
- No
Publications
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.
PubMed 37729184Maeda 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.
PubMed 34907192
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase Ia/Ib Multicenter Trial of Mogamulizumab for Advanced or Recurrent Cancer.
- ClinicalTrials.gov ID
- NCT01929486
- Acronym / sponsor ID
- KW0761-IIT-01
- Conditions
- Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Aichi Medical UniversityUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Jun 2016 (estimated)
- First posted
- 28 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| <Phase Ia> Mogamulizumab 0.1mg/kg, 0.5mg/kg or 1.0mg/kg | Experimental | Biological: Mogamulizumab<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 | Experimental | Biological: Mogamulizumab<Phase Ib> Mogamulizumab of the tolerated dose in Phase Ia will be administered 8 times every week. |
| <Phase Ib> Mogamulizumab 0.1mg/kg | Experimental | Biological: Mogamulizumab<Phase Ib> Mogamulizumab 0.1mg/kg will be administered 8 times every week. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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 %
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MogamulizumabAlso: KW-0761Mogamulizumab 0.1mg/kg, 0.5mg/kg or 1.0mg/kg will be administered 8 times every week. | Biological | <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 |
Primary outcome
Maximum tolerated dose(MTD) of Mogamulizumab
Time frame: from first administration until day 28
Dose limiting toxicity(DLT) of Mogamulizumab
Time frame: from first administration until day 28
Number of adverse events
Time frame: from first administration to 24 weeks after the final administration, an expected average of 32 weeks.
Cmax of Mogamulizumab
Time frame: from day 0 to 28 days after the final administration, an expected average of 12 weeks.
Ctrough of Mogamulizumab
Time frame: from day 0 to 28 days after the final administration, an expected average of 12 weeks.
AUC0-7day of Mogamulizumab
Time frame: 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
Time frame: from baseline to every 4 weeks until data cut off
3 secondary outcomes
Objective tumor response rate according to RECIST
Time frame: from baseline to every 12 weeks, until data cut off
Median progression free survival rate
Time frame: from baseline to every 12 weeks, until data cut off (expected date is March 2016)
Median Overall survival rate
Time frame: from baseline to every 12 weeks, until data cut off
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2016.
- Derived from this study: PubMed 37729184Fujikawa 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.
- Derived from this study: PubMed 34907192Maeda 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Mogamulizumab in people with Solid Tumor, run by Aichi Medical University at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum tolerated dose(MTD) of Mogamulizumab (time frame: from first administration until day 28). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01929486, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2016.