Renal Cell CarcinomaPhase 1NCT02216890
Safety Study of SGN-CD70A in Cancer Patients
A Phase 1 study testing SGN-CD70A in people with Renal Cell Carcinoma and Mantle-Cell Lymphoma, run by Seagen Inc. at 17 sites in United States.
Trial summary
This study will examine the safety profile of SGN-CD70A. The study will test increasing doses of SGN-CD70A given every 3 weeks (or an alternate dosing schedule up to every 6 weeks) to small groups of patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Cell Carcinoma, Mantle-Cell Lymphoma, Diffuse, Large B-Cell, Lymphoma
- What is being tested?
- SGN-CD70A
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 17 sitesUnited States
- Study dates
- Aug 2014to 15 Feb 2017
- 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
- Metastatic renal cell carcinoma, mantle cell lymphoma, or diffuse large B-cell lymphoma including Grade 3b follicular lymphoma
- Relapsed, refractory, or progressive disease following at least 2 prior systemic therapies
- Confirmed positive CD70 expression on tumor tissue
- Eastern Cooperative Oncology Group performance status 0 or 1
- Adequate baseline hematologic, pulmonary, renal, and hepatic function
- Measurable disease
Who cannot join
- Prior treatment with anti-CD70 directed therapy unless CD70 expression is confirmed on tumor tissue obtained after the treatment
- Patients <100 days since prior allogeneic stem cell transplant
- Less than 4 weeks since prior treatment; or 2 weeks if patient experienced disease progression on the prior treatment
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
United States17 sites
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109
Texas Oncology - Austin Midtown
Austin, Texas, 78705
University of Alabama at Birmingham
Birmingham, Alabama, 35294
UNC Lineberger Comprehensive Cancer Center / University of North Carolina
Chapel Hill, North Carolina, 27599
Medical University of South Carolina/Hollings Cancer Center
Charleston, South Carolina, 29425
University of Cincinnati Cancer Institute
Cincinnati, Ohio, 45267
Case Western Reserve University / University Hospitals Case Medical Center
Cleveland, Ohio, 44106
Karmanos Cancer Institute / Wayne State University
Detroit, Michigan, 48201
City of Hope National Medical Center
Duarte, California, 91010-3000
Methodist Cancer Center
Houston, Texas, 77030
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89169
Cardinal Bernardin Cancer Center / Loyola University Medical Center
Maywood, Illinois, 60153
University of Pennsylvania / Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania, 19104
James P. Wilmot Cancer Center / University of Rochester Medical Center
Rochester, New York, 14642
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229
Seattle Cancer Care Alliance / University of Washington
Seattle, Washington, 98109-1023
Northwest Cancer Specialists, P.C.
Vancouver, Washington, 98684
About this study
Official title: A Phase 1 Trial of SGN-CD70A in Patients With CD70-Positive Malignancies
This study will examine the safety profile of SGN-CD70A. The study will test increasing doses of SGN-CD70A given every 3 weeks (or an alternate dosing schedule up to every 6 weeks) to small groups of patients. The goal is to find the highest dose of SGN-CD70A that can be given to patients without causing unacceptable side effects. The pharmacokinetics and antitumor activity of SGN-CD70A will also be evaluated.
- Conditions
- Renal Cell Carcinoma, Mantle-Cell Lymphoma, Diffuse, Large B-Cell, Lymphoma, Follicular Lymphoma, Grade 3
- Being tested
- SGN-CD70A
- Keywords
- Renal Cell Carcinoma, Mantle-Cell Lymphoma, Diffuse, Large B-Cell, Lymphoma, Follicular Lymphoma, Grade 3, Antibody-Drug Conjugate, CD70 Antigen, Drug Therapy
- Medical subject headings
- Carcinoma, Renal Cell, Lymphoma, Mantle-Cell, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SGN-CD70ADrug
Given intravenously every 3 weeks (or an alternate dosing schedule up to every 6 weeks)
| Study group | Role | What they receive |
|---|---|---|
| SGN-CD70A | Experimental | Not described Receives: Drug: SGN-CD70A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events
Measured: Through 1 month following last dose
Incidence of laboratory abnormalities
Measured: Through 1 month following last dose
Secondary outcomes (5)
Blood concentrations of SGN-CD70A and metabolites
Measured: Through 3 to 6 weeks after dosing
Incidence of antitherapeutic antibodies
Measured: Through 1 month following last dose
Objective response rate
Measured: Through 1 month following last dose
Progression-free survival
Measured: Approximately 3 years
Duration of response
Measured: 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 posted15 Aug 2014 (estimated)
- Study startAug 2014
- Primary completion15 Feb 2017
- Study completion15 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Cell CarcinomaStudies 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
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seagen Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Elaina Gartner, MD, Study director, Seagen Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02216890
- Sponsor's protocol ID
- SGN70A-001
- Status last verified
- Apr 2018
- First submitted
- 12 Aug 2014
- Last updated
- 19 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Trial of SGN-CD70A in Patients With CD70-Positive Malignancies
- ClinicalTrials.gov ID
- NCT02216890
- Acronym / sponsor ID
- SGN70A-001
- Conditions
- Renal Cell Carcinoma, Mantle-Cell Lymphoma, Diffuse, Large B-Cell, Lymphoma, Follicular Lymphoma, Grade 3
- Keywords
- Renal Cell Carcinoma, Mantle-Cell Lymphoma, Diffuse, Large B-Cell, Lymphoma, Follicular Lymphoma, Grade 3, Antibody-Drug Conjugate, CD70 Antigen, Drug Therapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Seagen Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2014 (actual)
- Primary completion
- 15 Feb 2017 (actual)
- Study completion
- 15 Feb 2017 (actual)
- First posted
- 15 Aug 2014 (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 will examine the safety profile of SGN-CD70A. The study will test increasing doses of SGN-CD70A given every 3 weeks (or an alternate dosing schedule up to every 6 weeks) to small groups of patients. The goal is to find the highest dose of SGN-CD70A that can be given to patients without causing unacceptable side effects. The pharmacokinetics and antitumor activity of SGN-CD70A will also be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SGN-CD70A | Experimental | Drug: SGN-CD70A |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Metastatic renal cell carcinoma, mantle cell lymphoma, or diffuse large B-cell lymphoma including Grade 3b follicular lymphoma
- Relapsed, refractory, or progressive disease following at least 2 prior systemic therapies
- Confirmed positive CD70 expression on tumor tissue
- Eastern Cooperative Oncology Group performance status 0 or 1
- Adequate baseline hematologic, pulmonary, renal, and hepatic function
Key exclusion criteria (3 listed)
- Prior treatment with anti-CD70 directed therapy unless CD70 expression is confirmed on tumor tissue obtained after the treatment
- Patients <100 days since prior allogeneic stem cell transplant
- Less than 4 weeks since prior treatment; or 2 weeks if patient experienced disease progression on the prior treatment
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-CD70AGiven intravenously every 3 weeks (or an alternate dosing schedule up to every 6 weeks) | Drug | SGN-CD70A |
Primary outcome
Incidence of adverse events
Time frame: Through 1 month following last dose
Incidence of laboratory abnormalities
Time frame: Through 1 month following last dose
5 secondary outcomes
Blood concentrations of SGN-CD70A and metabolites
Time frame: Through 3 to 6 weeks after dosing
Incidence of antitherapeutic antibodies
Time frame: Through 1 month following last dose
Objective response rate
Time frame: Through 1 month following last dose
Progression-free survival
Time frame: Approximately 3 years
Duration of response
Time frame: Approximately 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2018.
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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.
Elaina Gartner, MD study director
Seagen Inc.
17 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-CD70A in people with Renal Cell Carcinoma and Mantle-Cell Lymphoma, run by Seagen Inc. at 17 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 6 inclusion and 3 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 19 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incidence of adverse events (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 19 Apr 2018.