Carcinoma, Renal CellPhase 1NCT01015911
A Phase 1 Dose-escalation Trial of SGN-75 in CD70-positive Non-Hodgkin Lymphoma or Renal Cell Carcinoma
A Phase 1 study testing SGN-75 in people with Carcinoma, Renal Cell and Lymphoma, Non-Hodgkin, run by Seagen Inc. at 9 sites in United States.
Trial summary
This is a phase 1, open-label, dose-escalation clinical trial to evaluate the safety of SGN-75 in patients with CD70-positive relapsed or refractory non-Hodgkin lymphoma or metastatic renal cell carcinoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Renal Cell, Lymphoma, Non-Hodgkin
- What is being tested?
- SGN-75
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 9 sitesUnited States
- Study dates
- Nov 2009to Mar 2012
- 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
- Pathologically-confirmed diagnosis of NHL or RCC
- Relapsed, refractory, or progressive disease following at least 1 prior systemic therapy
- Confirmed CD70 expression
- Measurable disease, defined as at least 1 lesion >1.5 cm in the greatest transverse diameter for patients with NHL, and at least 1 non-resectable tumor lesion > or equal to 10 mm in diameter for patients with RCC
Who cannot join
- Previously received an allogeneic transplant
- History of another primary malignancy that has not been in remission for at least 3 years
- Prior anti-CD70-directed therapy
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
University of Alabama at Birmingham
Birmingham, Alabama, 35294-3300
Karmanos Cancer Institute / Wayne State University
Detroit, Michigan, 48201
City of Hope National Medical Center
Duarte, California, 91010-3000
MD Anderson Cancer Center / University of Texas
Houston, Texas, 77030
UCLA Medical Center / University of California at Los Angeles
Los Angeles, California, 90095-1678
Sarah Cannon Research Institute
Nashville, Tennessee, 37203
Memorial Sloan Kettering Cancer Center
New York, New York, 10021
Mayo Clinic
Rochester, Minnesota, 55905
Seattle Cancer Care Alliance / University of Washington
Seattle, Washington, 98109-1023
About this study
Official title: A Phase 1, Open-label, Dose-escalation Study to Evaluate the Safety and Tolerability of SGN-75 in Patients With CD70-positive Relapsed or Refractory Non-Hodgkin Lymphoma or Metastatic Renal Cell Carcinoma
This is a phase 1, open-label, dose-escalation clinical trial to evaluate the safety of SGN-75 in patients with CD70-positive relapsed or refractory non-Hodgkin lymphoma or metastatic renal cell carcinoma.
- Conditions
- Carcinoma, Renal Cell, Lymphoma, Non-Hodgkin
- Being tested
- SGN-75
- Keywords
- Antibodies, Monoclonal, Antibody-Drug Conjugate, Antigens, CD70, Lymphoma, Non-Hodgkin, Carcinoma, Renal Cell, Immunotherapy, Drug Therapy, monomethylauristatin F
- Medical subject headings
- Carcinoma, Renal Cell, Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SGN-75Drug
SGN-75 (IV) in 21- or 28-day cycles; dose range: 0.3-9 mg/kg
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | SGN-75 Receives: Drug: SGN-75 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events and laboratory abnormalities
Measured: Through 1 month following last dose
Secondary outcomes (4)
Best clinical response
Measured: Every 2 months
Duration of response, progression-free survival
Measured: Every 3 months until progression of disease or initiation of new treatment for cancer
Blood concentrations of SGN-75 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 posted18 Nov 2009 (estimated)
- Study startNov 2009
- Primary completionNov 2011
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Carcinoma, Renal CellStudies 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
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seagen Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nancy Whiting, PharmD, BCOP, Study director, Seagen Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01015911
- Sponsor's protocol ID
- SGN75-001
- Status last verified
- Dec 2014
- First submitted
- 13 Nov 2009
- Last updated
- 18 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Tannir NM, Forero-Torres A, Ramchandren R, Pal SK, Ansell SM, Infante JR, de Vos S, Hamlin PA, Kim SK, Whiting NC, Gartner EM, Zhao B, Thompson JA. Phase I dose-escalation study of SGN-75 in patients with CD70-positive relapsed/refractory non-Hodgkin lymphoma or metastatic renal cell carcinoma. Invest New Drugs. 2014 Dec;32(6):1246-57. doi: 10.1007/s10637-014-0151-0. Epub 2014 Aug 22.
PubMed 25142258
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label, Dose-escalation Study to Evaluate the Safety and Tolerability of SGN-75 in Patients With CD70-positive Relapsed or Refractory Non-Hodgkin Lymphoma or Metastatic Renal Cell Carcinoma
- ClinicalTrials.gov ID
- NCT01015911
- Acronym / sponsor ID
- SGN75-001
- Conditions
- Carcinoma, Renal Cell, Lymphoma, Non-Hodgkin
- Keywords
- Antibodies, Monoclonal, Antibody-Drug Conjugate, Antigens, CD70, Lymphoma, Non-Hodgkin, Carcinoma, Renal Cell, Immunotherapy, Drug Therapy, monomethylauristatin F
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Seagen Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2009
- Primary completion
- Nov 2011 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 18 Nov 2009 (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 is a phase 1, open-label, dose-escalation clinical trial to evaluate the safety of SGN-75 in patients with CD70-positive relapsed or refractory non-Hodgkin lymphoma or metastatic renal cell carcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: SGN-75SGN-75 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Pathologically-confirmed diagnosis of NHL or RCC
- Relapsed, refractory, or progressive disease following at least 1 prior systemic therapy
- Confirmed CD70 expression
- Measurable disease, defined as at least 1 lesion >1.5 cm in the greatest transverse diameter for patients with NHL, and at least 1 non-resectable tumor lesion > or equal to 10 mm in diameter for patients with RCC
Key exclusion criteria (3 listed)
- Previously received an allogeneic transplant
- History of another primary malignancy that has not been in remission for at least 3 years
- Prior anti-CD70-directed therapy
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-75SGN-75 (IV) in 21- or 28-day cycles; dose range: 0.3-9 mg/kg | Drug | 1 |
Primary outcome
Incidence of adverse events and laboratory abnormalities
Time frame: Through 1 month following last dose
4 secondary outcomes
Best clinical response
Time frame: Every 2 months
Duration of response, progression-free survival
Time frame: Every 3 months until progression of disease or initiation of new treatment for cancer
Blood concentrations of SGN-75 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 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 18 Dec 2014.
- Results publication: PubMed 25142258Tannir NM, Forero-Torres A, Ramchandren R, Pal SK, Ansell SM, Infante JR, de Vos S, Hamlin PA, Kim SK, Whiting NC, Gartner EM, Zhao B, Thompson JA. Phase I dose-escalation study of SGN-75 in patients with CD70-positive relapsed/refractory non-Hodgkin lymphoma or metastatic renal cell carcinoma. Invest New Drugs. 2014 Dec;32(6):1246-57. doi: 10.1007/s10637-014-0151-0. Epub 2014 Aug 22.
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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.
Nancy Whiting, PharmD, BCOP study director
Seagen Inc.
9 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-75 in people with Carcinoma, Renal Cell and Lymphoma, Non-Hodgkin, run by Seagen Inc. at 9 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 4 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 18 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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 and laboratory abnormalities (time frame: Through 1 month following last dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01015911, which also lists 1 linked publication.
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 Dec 2014.