Advanced Solid TumorsPhase 1/2NCT02281409
Safety, Tolerability, and Immunoregulatory Activity of Mogamulizumab (KW-0761) in Subjects With Advanced and/or Metastatic Solid Tumors
A Phase 1/2 study testing Mogamulizumab (KW-0761) in people with Advanced Solid Tumors and Metastatic Solid Tumors, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
The purpose of this study is to find out what effects, good and/or bad, KW-0761, an investigational drug, has on the patient and their cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumors, Metastatic Solid Tumors
- What is being tested?
- Mogamulizumab (KW-0761)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2014to Feb 2020
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed Consent form signed by the subject.
- Males and females 18 years or older at the time of dose initiation.
- Histologically confirmed unresectable solid tumor malignancy with at least 1 measurable lesion. In the expansion phase, eligibility will be limited to metastatic triple negative breast cancer that has received prior taxane and anthracycline therapy; Metastatic NSCLC that is not ALK+ and does not have a EGFR sensitizing mutation; and metastatic gastric cancer
- Previously treated for an advanced cancer and there are no curative therapy options available
- Karnofsky Performance Status ≥70 in the 30 day baseline period immediately prior to dosing.
- Evidence of adequate organ function by standard laboratory tests:
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- Serum creatinine (Cr) ≤1.5 X upper limit of normal (ULN)
- Serum total and (T -Bil ) ≤1.5 X ULN (prior diagnosis or past history consistent with Gilbert's syndrome is an exception)
- Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 X ULN
- Platelets (Plts) ≥ 100,000/μl
- Hemoglobin (Hgb) ≥ 9.0 g/dL
- Absolute neutrophil count (ANC) ≥1000/mm3
- All female subjects of childbearing age must be either surgically sterile, postmenopausal for at least 1 year, or using an acceptable method of contraception. Examples of adequate methods of contraception include abstinence, intrauterine device, hormonal contraception, use of spermicide and a condom by sexual partner, or partner with a vasectomy. Adequate contraception must be used from the beginning of the screening period until at least 16 weeks after the last dose of KW-0761. Male subjects with partners of childbearing potential must use a barrier method of contraception from the day of the first dose of KW-0761 until at least 16 weeks after the last dose.
- Life expectancy > 12 weeks
- Previously treated for advanced cancer with no additional therapy options available known to prolong survival.
Who cannot join
- Evidence of clinically significant of central nervous system (CNS) metastases or symptomatic CNS metastases within 30 days prior to dosing.
- History of autoimmune disease, except for vitiligo, diabetes, and autoimmune thyroiditis.
- A history of any major surgery within 6 weeks prior to dosing.
- Any history of systemic anticancer therapy (standard or experimental) completed within 30 days prior to dosing, with the exception of palliative ablation of lesion(s) as long as measurable disease lesion(s) remain for evaluation of exploratory endpoints.
- Any concomitant serious physical illness other than cancer (i.e., immune deficiency disease, bleeding disorder, etc.) within 1 year prior to dosing.
- Any history of Stevens-Johnson syndrome.
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- Clinically significant heart disease, defined as NYHA Class III or IV.
- Any allergic reaction to a previously administered monoclonal antibody or other therapeutic protein.
- Any significant systemic infection within 4 weeks prior to dosing.
- Pregnancy or breast-feeding.
- An existing diagnosis of HIV, hepatitis B, hepatitis C, or any current laboratory findings or clinical signs and symptoms that suggest these conditions.
- Subjects with active herpes simplex or herpes zoster. Subjects with a history of herpes zoster who have had an outbreak within the last year will also be excluded. Subjects on prophylaxis for herpes who started taking medication at least 30 days prior to study entry, should continue to take the prescribed medication for the duration of the study.
- Unresolved immune- related adverse events following prior biological therapy
- Use of any investigational drugs within 30 days prior to dosing.
- Any condition that requires or is likely to require treatment with systemic corticosteroids within the Core Study Period and short term follow-up.
- Subjects that have had a myocardial infarction within the last 6 months.
- Subjects on any immunomodulatory drug.
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
Official title: A Phase I/II Study of the Safety, Tolerability, and Immunoregulatory Activity of Mogamulizumab (KW-0761) in Subjects With Advanced and/or Metastatic Solid Tumors
The purpose of this study is to find out what effects, good and/or bad, KW-0761, an investigational drug, has on the patient and their cancer.
- Conditions
- Advanced Solid Tumors, Metastatic Solid Tumors
- Being tested
- Mogamulizumab (KW-0761)
- Keywords
- Mogamulizumab (KW-0761), 14-135
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mogamulizumab (KW-0761)Biological
| Study group | Role | What they receive |
|---|---|---|
| Phase I: Mogamulizumab (KW-0761) | Experimental | Patients will be enrolled to receive a weekly intravenous (IV) dose of KW-0761 ranging from 0.5 mg/kg to 10.0 mg/kg as feasible starting on Day 1 for 4 weeks. In the absence of toxicity or progression of disease, patients may continue receiving KW-0761 for up to 12 months. Subsequent treatment courses will consist of an infusion every other week. Following end of treatment or treatment completion date, a 24-week short term follow-up (STFU) period of observation will begin. Receives: Biological: Mogamulizumab (KW-0761) |
| Phase II: Mogamulizumab (KW-0761) | Experimental | Phase II of the study will enroll a total of 48 subjects, 16 patients in 3 tumor-specific expansion cohorts each treated at the RP2D (MTD, or highest dose tested in Phase I part of trial). Receives: Biological: Mogamulizumab (KW-0761) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose (MTD)
A standard 3+3 design will be utilized to determine the MTD. Four dose levels of KW-0761 will be investigated (0.5mg/kg, 1mg/kg, 3mg/kg, 10mg/kg). Patients will be treated in cohorts of size three to six and the dosage will be escalated if the clinical toxicity is acceptable.
Measured: 1 year
Secondary outcomes (1)
Overall Response
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2014 (estimated)
- Study startOct 2014
- Primary completionFeb 2020
- Study completionFeb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Advanced Solid TumorsStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Kyowa Hakko Kirin Pharma, Inc.
- Responsible party
- Sponsor
- Investigators
- Jedd Wolchok, MD, PhD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02281409
- Sponsor's protocol ID
- 14-135
- Status last verified
- Dec 2020
- First submitted
- 29 Oct 2014
- Last updated
- 23 Apr 2021
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Study of the Safety, Tolerability, and Immunoregulatory Activity of Mogamulizumab (KW-0761) in Subjects With Advanced and/or Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT02281409
- Acronym / sponsor ID
- 14-135
- Conditions
- Advanced Solid Tumors, Metastatic Solid Tumors
- Keywords
- Mogamulizumab (KW-0761), 14-135
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- Kyowa Hakko Kirin Pharma, Inc.
- Study start
- Oct 2014
- Primary completion
- Feb 2020 (actual)
- Study completion
- Feb 2020 (actual)
- First posted
- 3 Nov 2014 (estimated)
- Results
- Posted 23 Apr 2021
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 find out what effects, good and/or bad, KW-0761, an investigational drug, has on the patient and their cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phase I: Mogamulizumab (KW-0761) | Experimental | Biological: Mogamulizumab (KW-0761)Patients will be enrolled to receive a weekly intravenous (IV) dose of KW-0761 ranging from 0.5 mg/kg to 10.0 mg/kg as feasible starting on Day 1 for 4 weeks. In the absence of toxicity or progression of disease, patients may continue receiving KW-0761 for up to 12 months. Subsequent treatment courses will consist of an infusion every other week. Following end of treatment or treatment completion date, a 24-week short term follow-up (STFU) period of observation will begin. |
| Phase II: Mogamulizumab (KW-0761) | Experimental | Biological: Mogamulizumab (KW-0761)Phase II of the study will enroll a total of 48 subjects, 16 patients in 3 tumor-specific expansion cohorts each treated at the RP2D (MTD, or highest dose tested in Phase I part of trial). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Informed Consent form signed by the subject.
- Males and females 18 years or older at the time of dose initiation.
- Histologically confirmed unresectable solid tumor malignancy with at least 1 measurable lesion. In the expansion phase, eligibility will be limited to metastatic triple negative breast cancer that has received prior taxane and anthracycline therapy; Metastatic NSCLC that is not ALK+ and does not have a EGFR sensitizing mutation; and metastatic gastric cancer
- Previously treated for an advanced cancer and there are no curative therapy options available
- Karnofsky Performance Status ≥70 in the 30 day baseline period immediately prior to dosing.
Key exclusion criteria (17 listed)
- Evidence of clinically significant of central nervous system (CNS) metastases or symptomatic CNS metastases within 30 days prior to dosing.
- History of autoimmune disease, except for vitiligo, diabetes, and autoimmune thyroiditis.
- A history of any major surgery within 6 weeks prior to dosing.
- Any history of systemic anticancer therapy (standard or experimental) completed within 30 days prior to dosing, with the exception of palliative ablation of lesion(s) as long as measurable disease lesion(s) remain for evaluation of exploratory endpoints.
- Any concomitant serious physical illness other than cancer (i.e., immune deficiency disease, bleeding disorder, etc.) within 1 year prior to dosing.
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 |
|---|---|---|
| Mogamulizumab (KW-0761) | Biological | Phase I: Mogamulizumab (KW-0761), Phase II: Mogamulizumab (KW-0761) |
Primary outcome
Maximum Tolerated Dose (MTD)
Time frame: 1 year
A standard 3+3 design will be utilized to determine the MTD. Four dose levels of KW-0761 will be investigated (0.5mg/kg, 1mg/kg, 3mg/kg, 10mg/kg). Patients will be treated in cohorts of size three to six and the dosage will be escalated if the clinical toxicity is acceptable.
1 secondary outcome
Overall Response
Time frame: 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
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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.
Jedd Wolchok, MD, PhD principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Mogamulizumab (KW-0761) in people with Advanced Solid Tumors and Metastatic Solid Tumors, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
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 15 inclusion and 17 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: finished, as of the sponsor's last update on 23 Apr 2021. 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 United States. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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) (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Apr 2021.