Carcinoma, Non-Small-Cell LungPhase 1NCT02952989
A Safety Study of SGN-2FF for Patients With Advanced Solid Tumors
A Phase 1 study testing SGN-2FF and pembrolizumab in people with Carcinoma, Non-Small-Cell Lung and Carcinoma, Renal Cell, run by Seagen Inc. at 11 sites in United States.
Trial summary
This study is being done to find out the side effects (unwanted effects) that are caused in patients with cancers who are given SGN-2FF. This study will also attempt to find the most suitable dose in the disease or condition being studied and look at other effects of SGN2FF, including its effect on cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung, Carcinoma, Renal Cell, Breast Neoplasms
- What is being tested?
- SGN-2FF and pembrolizumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 11 sitesUnited States
- Study dates
- 23 Feb 2017to 24 Jun 2019
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with histologically or cytologically-confirmed, locally advanced, or metastatic solid malignancy that is relapsed, refractory, or progressing following at least 1 prior systemic therapy (Part A)
- Measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) as defined by RECIST 1.1
- Eastern Cooperative Oncology Group (ECOG) performance status of less than or equal to 1
- Patients in Part B must have histologically or cytologically-confirmed, locally-advanced, or metastatic solid malignancy within the disease indications of Part A
- Adequate baseline hematologic, renal, and hepatic function
- Patients for whom there is no further standard therapy available at the time of enrollment (Part A)
- Patients with a histologically-confirmed, advanced solid malignancy meeting one of the following criteria: (1) indication for which pembrolizumab is approved or (2) relapsed, refractory, or progressive disease following at least 1 prior therapy and for which no further standard therapy is a available (Parts C and D)
Who cannot join
- Patients with carcinomatous meningitis or active central nervous system (CNS) metastases
- Patients with recent (within 14 days) or serious ongoing infection
- Patients requiring systemic treatment with corticosteroids (greater than 10 mg prednisone equivalents) or immunosuppressive medications within 14 days of enrollment
- Patients with active known or suspected autoimmune disease or significant autoimmune-related toxicity from prior immuno-oncology therapy
- Known active or latent tuberculosis
- Uncontrolled diabetes mellitus
Show all 12Show fewer
- History of interstitial lung disease
- Gastrointestinal abnormality that would affect absorption of SGN-2FF
- Patients tested positive for hepatitis B or with a known, active hepatitis C infection
- Women who are pregnant or breastfeeding
- Patients with deep vein thrombosis (DVT)
- Contraindication to prophylactic anticoagulation
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Winship Cancer Institute / Emory University School of Medicine
Atlanta, Georgia, 30322
University of Colorado Hospital / University of Colorado
Aurora, Colorado, 80045-0510
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
Karmanos Cancer Institute / Wayne State University
Detroit, Michigan, 48201
City of Hope National Medical Center
Duarte, California, 91010-3000
Duke University Medical Center
Durham, North Carolina, 27710
MD Anderson Cancer Center / University of Texas
Houston, Texas, 77030-4095
Sarah Cannon Research Institute
Nashville, Tennessee, 37203
Providence Portland Medical Center
Portland, Oregon, 97213
Seattle Cancer Care Alliance / University of Washington
Seattle, Washington, 98109-1023
About this study
Official title: A Phase 1, Multicenter, Open-label, Dose-escalation Study of SGN-2FF in Patients With Advanced Solid Tumors
This study is being done to find out the side effects (unwanted effects) that are caused in patients with cancers who are given SGN-2FF. This study will also attempt to find the most suitable dose in the disease or condition being studied and look at other effects of SGN2FF, including its effect on cancer.
This study has several different parts. Part A will try to find the highest safe dose. Part B will enroll more patients to be treated at the highest safe dose or a lower dose to better understand how well SGN-2FF is tolerated. Part C will try to find the highest safe dose of SGN-2FF when it is given combined with pembrolizumab. Pembrolizumab is a standard treatment for cancer. Part D will enroll more patients to be treated at the highest safe dose of SGN-2FF combined with pembrolizumab or a lower dose of SGN-2FF to better understand how well SGN-2FF is tolerated when it is given with pembrolizumab.
Read the detailed description
This is a phase 1, open-label, multicenter, dose escalation study that will examine the safety profile of SGN-2FF given orally to patients with advanced solid tumors. The primary goal of the study is to identify the maximum tolerated dose (MTD), or optimal biological dose (OBD) that does not exceed the MTD. The pharmacokinetics (PK) and antitumor activity of SGN-2FF will also be evaluated. In this study, SGN-2FF will be evaluated as monotherapy and as combination therapy with the standard approved dose of pembrolizumab.
The monotherapy portion of the study will be conducted in 2 sequential parts (Part A and Part B). Part A will enroll patients for dose escalation to estimate the MTD /OBD and help determine the dosing regimen that will be tested in Part B. The OBD will be evaluated by assessing the activity of SGN-2FF, including pharmacodynamics, PK, and other observations in dose escalation. Part B will explore the recommended dose/regimen in up to 3 focused expansion cohorts.
The combination therapy portion of the study will be conducted in 2 sequential parts (Part C and Part D). SGN-2FF will be administered orally according to the dose and schedule assigned, with a lead-in period of 2 weeks prior to pembrolizumab administration. The lead-in period may be discontinued based on emerging nonclinical and/or clinical data. Part C will enroll patients for dose escalation to estimate the MTD /OBD and the dosing regimen that will be tested in Part D. Part D will explore the recommended dose/regimen in up to 3 focused expansion cohorts.
Safety will be monitored throughout the trial by the safety monitoring committee which will meet frequently to review the emerging safety data and make dose-escalation and dosing-interval recommendations. Antitumor activity will be assessed by radiographic imaging. Patients may continue treatment until progression of their disease or intolerable side effects.
Retreatment with SGN-2FF monotherapy or with SGN-2FF and pembrolizumab combination therapy is permitted with medical monitor approval for patients who achieve stable disease, a complete response, or partial response on study and then experience disease progression after discontinuing prior treatment with SGN 2FF.
- Conditions
- Carcinoma, Non-Small-Cell Lung, Carcinoma, Renal Cell, Breast Neoplasms, Urinary Bladder Neoplasm, Carcinoma, Squamous Cell of Head and Neck, Colorectal Neoplasms
- Being tested
- SGN-2FF, pembrolizumab
- Keywords
- MSI-high, dMMR, PD-L1
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Carcinoma, Renal Cell, Breast Neoplasms, Urinary Bladder Neoplasms, Squamous Cell Carcinoma of Head and Neck, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SGN-2FFDrug
Also called 2-fluorofucose
SGN-2FF oral daily dosing.
pembrolizumabDrug
Also called Keytruda
200 mg every 3 weeks by IV infusion
| Study group | Role | What they receive |
|---|---|---|
| SGN-2FF | Experimental | Dose escalation and dose expansion Receives: Drug: SGN-2FF |
| SGN-2FF and Pembrolizumab | Experimental | Dose escalation and dose expansion Receives: Drug: SGN-2FF; Drug: pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of participants with adverse events that are related to treatment
The number of patients who have side effects that are related to the study drug
Measured: Up to 90 days following last dose
The number of participants with laboratory abnormalities that are related to treatment
The number of patients who have laboratory test results that are outside the normal range
Measured: Up to 90 days following last dose
Incidence of dose-limiting toxicities (DLTs)
The rate of occurrence of side effects that prevent giving more of the treatment
Measured: 28 days from first dose
Secondary outcomes (8)
Pharmacokinetic assessments
Selected PK parameters, including area under the curve, maximum observed concentration, time to maximum observed concentration, and trough concentration.
Measured: Relative to most recent dosing event
Markers of fucosylation status
Changes in pharmacodynamic biomarkers of fucosylation across dose levels
Measured: Up to 90 days following last dose
Objective response rate
The proportion of patients who achieve a complete response (CR) or partial response (PR).
Measured: Up to 90 days following last dose
Disease control rate
The proportion of patients who achieve either complete response (CR), partial response (PR), or stable disease (SD)
Measured: Up to approximately 5 years
Duration of response
The time from the first documentation of objective response (CR or PR) to the first documentation of tumor progression (progressive disease per response criteria or clinical disease progression) or to death due to any cause, whichever comes first
Measured: Up to approximately 5 years
Clinical benefit rate
The proportion of patients who achieve either complete response (CR), partial response (PR), or stable disease (SD) for at least 24 weeks
Measured: Up to approximately 5 years
Progression-free survival
The time from start of study treatment to the first documentation of tumor progression (progressive disease per response criteria or clinical disease progression) or death due to any cause, whichever comes first
Measured: Up to approximately 5 years
Overall survival
The time from start of study treatment to date of death due to any cause
Measured: Up to approximately 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2016 (estimated)
- Study start23 Feb 2017
- Primary completion24 Jun 2019
- Study completion24 Jun 2019
Why it stopped: Due to overall benefit/risk profile
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Non-Small-Cell LungStudies 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
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seagen Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christina Derleth, MD, Study director, Seagen Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02952989
- Sponsor's protocol ID
- SGN2FF-001
- Status last verified
- Jul 2019
- First submitted
- 27 Oct 2016
- Last updated
- 19 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Multicenter, Open-label, Dose-escalation Study of SGN-2FF in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT02952989
- Acronym / sponsor ID
- SGN2FF-001
- Conditions
- Carcinoma, Non-Small-Cell Lung, Carcinoma, Renal Cell, Breast Neoplasms, Urinary Bladder Neoplasm, Carcinoma, Squamous Cell of Head and Neck, Colorectal Neoplasms
- Keywords
- MSI-high, dMMR, PD-L1
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to overall benefit/risk profile
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Seagen Inc.Industry (pharma, biotech, devices)
- Study start
- 23 Feb 2017 (actual)
- Primary completion
- 24 Jun 2019 (actual)
- Study completion
- 24 Jun 2019 (actual)
- First posted
- 2 Nov 2016 (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.
This study is being done to find out the side effects (unwanted effects) that are caused in patients with cancers who are given SGN-2FF. This study will also attempt to find the most suitable dose in the disease or condition being studied and look at other effects of SGN2FF, including its effect on cancer.
This study has several different parts. Part A will try to find the highest safe dose. Part B will enroll more patients to be treated at the highest safe dose or a lower dose to better understand how well SGN-2FF is tolerated. Part C will try to find the highest safe dose of SGN-2FF when it is given combined with pembrolizumab. Pembrolizumab is a standard treatment for cancer. Part D will enroll more patients to be treated at the highest safe dose of SGN-2FF combined with pembrolizumab or a lower dose of SGN-2FF to better understand how well SGN-2FF is tolerated when it is given with pembrolizumab.
Detailed description
This is a phase 1, open-label, multicenter, dose escalation study that will examine the safety profile of SGN-2FF given orally to patients with advanced solid tumors. The primary goal of the study is to identify the maximum tolerated dose (MTD), or optimal biological dose (OBD) that does not exceed the MTD. The pharmacokinetics (PK) and antitumor activity of SGN-2FF will also be evaluated. In this study, SGN-2FF will be evaluated as monotherapy and as combination therapy with the standard approved dose of pembrolizumab.
The monotherapy portion of the study will be conducted in 2 sequential parts (Part A and Part B). Part A will enroll patients for dose escalation to estimate the MTD /OBD and help determine the dosing regimen that will be tested in Part B. The OBD will be evaluated by assessing the activity of SGN-2FF, including pharmacodynamics, PK, and other observations in dose escalation. Part B will explore the recommended dose/regimen in up to 3 focused expansion cohorts.
The combination therapy portion of the study will be conducted in 2 sequential parts (Part C and Part D). SGN-2FF will be administered orally according to the dose and schedule assigned, with a lead-in period of 2 weeks prior to pembrolizumab administration. The lead-in period may be discontinued based on emerging nonclinical and/or clinical data. Part C will enroll patients for dose escalation to estimate the MTD /OBD and the dosing regimen that will be tested in Part D. Part D will explore the recommended dose/regimen in up to 3 focused expansion cohorts.
Safety will be monitored throughout the trial by the safety monitoring committee which will meet frequently to review the emerging safety data and make dose-escalation and dosing-interval recommendations. Antitumor activity will be assessed by radiographic imaging. Patients may continue treatment until progression of their disease or intolerable side effects.
Retreatment with SGN-2FF monotherapy or with SGN-2FF and pembrolizumab combination therapy is permitted with medical monitor approval for patients who achieve stable disease, a complete response, or partial response on study and then experience disease progression after discontinuing prior treatment with SGN 2FF.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SGN-2FF | Experimental | Drug: SGN-2FFDose escalation and dose expansion |
| SGN-2FF and Pembrolizumab | Experimental | Drug: SGN-2FF, Drug: pembrolizumabDose escalation and dose expansion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients with histologically or cytologically-confirmed, locally advanced, or metastatic solid malignancy that is relapsed, refractory, or progressing following at least 1 prior systemic therapy (Part A)
- Measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) as defined by RECIST 1.1
- Eastern Cooperative Oncology Group (ECOG) performance status of less than or equal to 1
- Patients in Part B must have histologically or cytologically-confirmed, locally-advanced, or metastatic solid malignancy within the disease indications of Part A
- Adequate baseline hematologic, renal, and hepatic function
Key exclusion criteria (12 listed)
- Patients with carcinomatous meningitis or active central nervous system (CNS) metastases
- Patients with recent (within 14 days) or serious ongoing infection
- Patients requiring systemic treatment with corticosteroids (greater than 10 mg prednisone equivalents) or immunosuppressive medications within 14 days of enrollment
- Patients with active known or suspected autoimmune disease or significant autoimmune-related toxicity from prior immuno-oncology therapy
- Known active or latent tuberculosis
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 |
|---|---|---|
| SGN-2FFAlso: 2-fluorofucoseSGN-2FF oral daily dosing. | Drug | SGN-2FF, SGN-2FF and Pembrolizumab |
| pembrolizumabAlso: Keytruda200 mg every 3 weeks by IV infusion | Drug | SGN-2FF and Pembrolizumab |
Primary outcome
The number of participants with adverse events that are related to treatment
Time frame: Up to 90 days following last dose
The number of patients who have side effects that are related to the study drug
The number of participants with laboratory abnormalities that are related to treatment
Time frame: Up to 90 days following last dose
The number of patients who have laboratory test results that are outside the normal range
Incidence of dose-limiting toxicities (DLTs)
Time frame: 28 days from first dose
The rate of occurrence of side effects that prevent giving more of the treatment
8 secondary outcomes
Pharmacokinetic assessments
Time frame: Relative to most recent dosing event
Markers of fucosylation status
Time frame: Up to 90 days following last dose
Objective response rate
Time frame: Up to 90 days following last dose
Disease control rate
Time frame: Up to approximately 5 years
Duration of response
Time frame: Up to approximately 5 years
Clinical benefit rate
Time frame: Up to approximately 5 years
Progression-free survival
Time frame: Up to approximately 5 years
Overall survival
Time frame: Up to approximately 5 years
Results and safety
The study was stopped early (reason given: Due to overall benefit/risk profile). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2019.
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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.
Christina Derleth, MD study director
Seagen Inc.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SGN-2FF and pembrolizumab in people with Carcinoma, Non-Small-Cell Lung and Carcinoma, Renal Cell, run by Seagen Inc. at 11 sites 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 7 inclusion and 12 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: stopped early, as of the sponsor's last update on 19 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites 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 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?
The study was stopped early (reason given: Due to overall benefit/risk profile). 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?
The number of participants with adverse events that are related to treatment (time frame: Up to 90 days following last dose). The study lists 3 primary outcomes in all. 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 19 Jul 2019.