Multiple MyelomaPhase 1NCT02954796
A Safety Study of SGN-CD352A for Patients With Relapsed/Refractory Multiple Myeloma
A Phase 1 study testing SGN-CD352A in people with Multiple Myeloma, run by Seagen Inc. at 11 sites in United States.
Trial summary
This study tests the safety of a drug called SGN-CD352A, to find out what its side effects are. SGN-CD352A will be given every 4 weeks to a small group of patients with multiple myeloma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- SGN-CD352A
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 11 sitesUnited States
- Study dates
- Dec 2016to 17 Jul 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
- Diagnosis of MM requiring systemic therapy (per the International Myeloma Working Group [IMWG] ).
- Age 18 years or older.
- An Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.
- Life expectancy greater than 3 months.
- Received at least 2 prior lines of therapy for MM including an immunomodulatory drug and a proteasome inhibitor.
- Measurable disease, as defined by at least one of the following: Serum M protein 0.5 g/dL or higher, Urine M protein 200 mg/24 hr or higher, Serum free light chain (SFLC) 10 mg/dL or higher, and Abnormal SFLC ratio.
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- Adequate hematologic, renal, and hepatic function
- A negative pregnancy test (for females of childbearing potential).
- Patients must provide written informed consent.
Who cannot join
- Other invasive malignancy within the past 3 years.
- Active cerebral/meningeal disease related to the underlying malignancy.
- Active Grade 3 or higher infection.
- Known to be positive for HIV or known to have active hepatitis B or C.
- Previous allogeneic stem cell transplant.
- Idiopathic interstitial pneumonia or impaired diffusion capacity of the lung for carbon monoxide (DLCO).
- Cerebrovascular or cardiovascular event, or congestive heart failure within the last 6 months.
- Females who are pregnant or breastfeeding.
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
Charles A. Sammons Cancer Center / Baylor University Medical Center
Dallas, Texas, 75246
Karmanos Cancer Institute / Wayne State University
Detroit, Michigan, 48201
City of Hope National Medical Center
Duarte, California, 91010-3000
Hackensack University Medical Center
Hackensack, New Jersey, 07601
Holden Comprehensive Cancer Center / University of Iowa
Iowa City, Iowa, 52242
Weill Cornell Medical College
New York, New York, 10065
Mayo Clinic Arizona
Scottsdale, Arizona, 85259
Swedish Cancer Institute
Seattle, Washington, 98104
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109-1024
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: Phase 1 Study of SGN-CD352A in Patients With Relapsed or Refractory Multiple Myeloma
This study tests the safety of a drug called SGN-CD352A, to find out what its side effects are. SGN-CD352A will be given every 4 weeks to a small group of patients with multiple myeloma.
Read the detailed description
The study will have 2 parts. In the first part, different doses of SGN-CD352A will be given to different patients (each individual patient will get the same dose for all treatments). The doses will be very low at the start of the trial, and will increase only when the lower dose levels are proven safe.
In the second part of the study, up to 2 dose levels that are both safe and show promising activity against MM will be given to more patients
- Conditions
- Multiple Myeloma
- Being tested
- SGN-CD352A
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SGN-CD352ADrug
On the first day of each 28-day cycle, SGN-CD352A will be given IV. The dose of SGN-CD352A is different in each cohort of the study, with the lowest dose in Cohort -1 (4 mcg/kg) and the highest in Cohort 6 (65 mcg/kg). Patients can only be enrolled into a higher dose level arm if lower doses have proven safe.
| Study group | Role | What they receive |
|---|---|---|
| (Dose Escalation) Cohort -1 - 6 | Experimental | SGN-CD352A will be given intravenously (into a vein; IV) every 28 days at increasing doses. Receives: Drug: SGN-CD352A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Type, incidence, severity, seriousness, and relatedness of adverse events (including laboratory abnormalities)
Measured: Through 1 month following last dose.
Incidence of dose-limiting toxicity
Measured: During Cycle 1 (Trial Days 1-28)
Secondary outcomes (8)
Overall survival
Measured: Up to approximately 3 years
Progression-free survival
Measured: Up to approximately 3 years
Duration of objective response
Measured: Up to approximately 3 years
Duration of complete response
Measured: Up to approximately 3 years
Objective response rate
Measured: Up to approximately 3 years
Complete response rate
Measured: Up to approximately 3 years
Incidence of antitherapeutic antibodies (ATA)
Measured: Up to approximately 3 years
Blood concentrations of SGN-CD352A and metabolites
Measured: Up to approximately 3 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 2016 (estimated)
- Study startDec 2016
- Primary completion17 Jul 2019
- Study completion17 Jul 2019
Why it stopped: Sponsor decision based on portfolio prioritization
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seagen Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mary Campbell, MD, Study director, Seagen Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02954796
- Sponsor's protocol ID
- SGN352-001
- Status last verified
- Aug 2019
- First submitted
- 28 Oct 2016
- Last updated
- 12 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study of SGN-CD352A in Patients With Relapsed or Refractory Multiple Myeloma
- ClinicalTrials.gov ID
- NCT02954796
- Acronym / sponsor ID
- SGN352-001
- Conditions
- Multiple Myeloma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor decision based on portfolio prioritization
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Seagen Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2016 (actual)
- Primary completion
- 17 Jul 2019 (actual)
- Study completion
- 17 Jul 2019 (actual)
- First posted
- 3 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 tests the safety of a drug called SGN-CD352A, to find out what its side effects are. SGN-CD352A will be given every 4 weeks to a small group of patients with multiple myeloma.
Detailed description
The study will have 2 parts. In the first part, different doses of SGN-CD352A will be given to different patients (each individual patient will get the same dose for all treatments). The doses will be very low at the start of the trial, and will increase only when the lower dose levels are proven safe.
In the second part of the study, up to 2 dose levels that are both safe and show promising activity against MM will be given to more patients
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| (Dose Escalation) Cohort -1 - 6 | Experimental | Drug: SGN-CD352ASGN-CD352A will be given intravenously (into a vein; IV) every 28 days at increasing doses. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Diagnosis of MM requiring systemic therapy (per the International Myeloma Working Group [IMWG] ).
- Age 18 years or older.
- An Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.
- Life expectancy greater than 3 months.
- Received at least 2 prior lines of therapy for MM including an immunomodulatory drug and a proteasome inhibitor.
Key exclusion criteria (8 listed)
- Other invasive malignancy within the past 3 years.
- Active cerebral/meningeal disease related to the underlying malignancy.
- Active Grade 3 or higher infection.
- Known to be positive for HIV or known to have active hepatitis B or C.
- Previous allogeneic stem cell transplant.
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-CD352AOn the first day of each 28-day cycle, SGN-CD352A will be given IV. The dose of SGN-CD352A is different in each cohort of the study, with the lowest dose in Cohort -1 (4 mcg/kg) and the highest in Cohort 6 (65 mcg/kg). Patients can only be enrolled into a higher dose level arm if lower doses have proven safe. | Drug | (Dose Escalation) Cohort -1 - 6 |
Primary outcome
Type, incidence, severity, seriousness, and relatedness of adverse events (including laboratory abnormalities)
Time frame: Through 1 month following last dose.
Incidence of dose-limiting toxicity
Time frame: During Cycle 1 (Trial Days 1-28)
8 secondary outcomes
Overall survival
Time frame: Up to approximately 3 years
Progression-free survival
Time frame: Up to approximately 3 years
Duration of objective response
Time frame: Up to approximately 3 years
Duration of complete response
Time frame: Up to approximately 3 years
Objective response rate
Time frame: Up to approximately 3 years
Complete response rate
Time frame: Up to approximately 3 years
Incidence of antitherapeutic antibodies (ATA)
Time frame: Up to approximately 3 years
Blood concentrations of SGN-CD352A and metabolites
Time frame: Up to approximately 3 years
Results and safety
The study was stopped early (reason given: Sponsor decision based on portfolio prioritization). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 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.
Mary Campbell, 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-CD352A in people with Multiple Myeloma, 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 9 inclusion and 8 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 12 Aug 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: Sponsor decision based on portfolio prioritization). 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?
Type, incidence, severity, seriousness, and relatedness of adverse events (including laboratory abnormalities) (time frame: Through 1 month following last dose.). The study lists 2 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 12 Aug 2019.