Multiple MyelomaPhase 1NCT03379584
A Safety Study of SGN-CD48A in Patients With Multiple Myeloma
A Phase 1 study testing SGN-CD48A in people with Multiple Myeloma, run by Seagen Inc. at 6 sites in United States.
Trial summary
This study will test the safety and activity of SGN-CD48A in patients with multiple myeloma. SGN-CD48A will be given on Days 1, 8, and 15 of a 28-day cycle. Prior to protocol amendment 2, SGN-CD48A was given every 3 weeks. 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-CD48A
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 6 sitesUnited States
- Study dates
- 20 Feb 2018to 23 Aug 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])
- Patients must not have other therapeutic options known to provide clinical benefit in MM available to them. Prior lines of therapy must include at least a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 antibody.
- Measureable 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 hour or higher, and serum immunoglobulin free light chain 10 mg/dL or higher and abnormal serum immunoglobulin kappa lambda free light chain ratio
- Adequate hematologic, renal, and hepatic function
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Life expectancy greater than 3 months
- A negative pregnancy test (for females of childbearing potential)
- Patients must provide written consent
Who cannot join
- Pre-existing peripheral neuropathy Grade 2 or higher
- History of malignancy other than MM within the past 3 years
- Active cerebral/meningeal disease related to the underlying malignancy
- Uncontrolled Grade 3 or higher infection
- Known to be positive for HIV or hepatitis B, or known to have active hepatitis C infection
- Previous allogeneic stem cell transplant
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- History of cerebral vascular event, unstable angina, myocardial infarction, or cardiac symptoms consistent with congestive heart failure within the last 6 months
- Treatment with any known P-gp inducers/inhibitors or strong CYP3A inhibitors within 14 days prior to the first dose of study drug
- Prior antitumor therapy that is not completed at least 4 weeks prior to first dose of study drug, or at least 2 weeks if progressing. Prior CAR T-cell therapy must be completed 8 weeks before first dose of study drug.
- Females who are pregnant or breastfeeding
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Levine Cancer Institute
Charlotte, North Carolina, 28204
Yale Cancer Center
New Haven, Connecticut, 06520
Mount Sinai Medical Center
New York, New York, 10029
University of Pennsylvania / Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania, 19104
University of California at San Francisco
San Francisco, California, 94134
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612
About this study
Official title: A Phase 1 Study of SGN-CD48A in Patients With Relapsed or Refractory Multiple Myeloma
This study will test the safety and activity of SGN-CD48A in patients with multiple myeloma. SGN-CD48A will be given on Days 1, 8, and 15 of a 28-day cycle. Prior to protocol amendment 2, SGN-CD48A was given every 3 weeks.
Read the detailed description
This study is designed to evaluate the safety, tolerability, and antitumor activity of SGN-CD48A in patients with relapsed or refractory multiple myeloma. This study will be conducted in 2 parts:
- Dose escalation: This part will evaluate increasing doses of SGN-CD48A to identify the maximum tolerated dose. The first group of patients enrolled on the study will receive the lowest dose of SGN-CD48A. Once this dose is shown to be safe, a second group of patients will be enrolled at the next higher dose. Patients will continue to be enrolled in groups receiving increasing doses until the maximum tolerated dose level is reached. Patients can only be enrolled into a higher dose level once the lower doses have been demonstrated safe. Dose escalation will be conducted using a modified toxicity probability interval (mTPI) study design.
- Dose expansion: This part will further evaluate the safety, tolerability, and antitumor activity of up to 2 dose levels of SGN-CD48A shown to be safe in the first part of the trial.
- Conditions
- Multiple Myeloma
- Being tested
- SGN-CD48A
- Keywords
- Multiple myeloma, Antibody-drug conjugate
- 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-CD48ADrug
Intravenous (IV) infusion on days 1, 8, and 15 of a 28-day cycle
| Study group | Role | What they receive |
|---|---|---|
| SGN-CD48A | Experimental | SGN-CD48A Receives: Drug: SGN-CD48A |
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
Measured: Through 1 month following last dose
Incidence of laboratory abnormalities
Measured: Through 1 month following last dose
Incidence of dose limiting toxicity
Measured: Through 3 weeks following first dose
Secondary outcomes (8)
Objective response rate
The proportion of patients with stringent complete response, complete response, very good partial response, or partial response per investigator
Measured: Through 1 month following last dose
Complete response rate
The proportion of patients with stringent complete response or complete response per investigator
Measured: Through 1 month following last dose
Duration of objective response
Measured: Up to approximately 3 years
Duration of complete response
Measured: Up to approximately 3 years
Progression-free survival
Measured: Up to approximately 3 years
Overall survival
Measured: Up to approximately 3 years
Blood concentrations of SGN-CD48A and metabolites
Measured: Through 1 month following last dose
Incidence of antitherapeutic antibodies
Measured: Through 1 month following last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2017
- Study start20 Feb 2018
- Primary completion23 Aug 2019
- Study completion23 Aug 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 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
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seagen Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Suzanne McGoldrick, MD, MPH, Study director, Seagen Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03379584
- Sponsor's protocol ID
- SGN48A-001
- Status last verified
- Sep 2019
- First submitted
- 13 Dec 2017
- Last updated
- 18 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study of SGN-CD48A in Patients With Relapsed or Refractory Multiple Myeloma
- ClinicalTrials.gov ID
- NCT03379584
- Acronym / sponsor ID
- SGN48A-001
- Conditions
- Multiple Myeloma
- Keywords
- Multiple myeloma, Antibody-drug conjugate
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to overall benefit/risk profile
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Seagen Inc.Industry (pharma, biotech, devices)
- Study start
- 20 Feb 2018 (actual)
- Primary completion
- 23 Aug 2019 (actual)
- Study completion
- 23 Aug 2019 (actual)
- First posted
- 20 Dec 2017 (actual)
- 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 will test the safety and activity of SGN-CD48A in patients with multiple myeloma. SGN-CD48A will be given on Days 1, 8, and 15 of a 28-day cycle. Prior to protocol amendment 2, SGN-CD48A was given every 3 weeks.
Detailed description
This study is designed to evaluate the safety, tolerability, and antitumor activity of SGN-CD48A in patients with relapsed or refractory multiple myeloma. This study will be conducted in 2 parts:
- Dose escalation: This part will evaluate increasing doses of SGN-CD48A to identify the maximum tolerated dose. The first group of patients enrolled on the study will receive the lowest dose of SGN-CD48A. Once this dose is shown to be safe, a second group of patients will be enrolled at the next higher dose. Patients will continue to be enrolled in groups receiving increasing doses until the maximum tolerated dose level is reached. Patients can only be enrolled into a higher dose level once the lower doses have been demonstrated safe. Dose escalation will be conducted using a modified toxicity probability interval (mTPI) study design.
- Dose expansion: This part will further evaluate the safety, tolerability, and antitumor activity of up to 2 dose levels of SGN-CD48A shown to be safe in the first part of the trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SGN-CD48A | Experimental | Drug: SGN-CD48ASGN-CD48A |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Diagnosis of MM requiring systemic therapy (per the International Myeloma Working Group [IMWG])
- Patients must not have other therapeutic options known to provide clinical benefit in MM available to them. Prior lines of therapy must include at least a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 antibody.
- Measureable 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 hour or higher, and serum immunoglobulin free light chain 10 mg/dL or higher and abnormal serum immunoglobulin kappa lambda free light chain ratio
- Adequate hematologic, renal, and hepatic function
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Key exclusion criteria (10 listed)
- Pre-existing peripheral neuropathy Grade 2 or higher
- History of malignancy other than MM within the past 3 years
- Active cerebral/meningeal disease related to the underlying malignancy
- Uncontrolled Grade 3 or higher infection
- Known to be positive for HIV or hepatitis B, or known to have active hepatitis C infection
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-CD48AIntravenous (IV) infusion on days 1, 8, and 15 of a 28-day cycle | Drug | SGN-CD48A |
Primary outcome
Type, incidence, severity, seriousness, and relatedness of adverse events
Time frame: Through 1 month following last dose
Incidence of laboratory abnormalities
Time frame: Through 1 month following last dose
Incidence of dose limiting toxicity
Time frame: Through 3 weeks following first dose
8 secondary outcomes
Objective response rate
Time frame: Through 1 month following last dose
Complete response rate
Time frame: Through 1 month following last dose
Duration of objective response
Time frame: Up to approximately 3 years
Duration of complete response
Time frame: Up to approximately 3 years
Progression-free survival
Time frame: Up to approximately 3 years
Overall survival
Time frame: Up to approximately 3 years
Blood concentrations of SGN-CD48A and metabolites
Time frame: Through 1 month following last dose
Incidence of antitherapeutic antibodies
Time frame: Through 1 month following last dose
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 18 Sep 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.
Suzanne McGoldrick, MD, MPH study director
Seagen Inc.
6 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-CD48A in people with Multiple Myeloma, run by Seagen Inc. at 6 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 8 inclusion and 10 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 18 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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?
Type, incidence, severity, seriousness, and relatedness of adverse events (time frame: Through 1 month 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 18 Sep 2019.