Clinical trial NCT01015911: A Phase 1 Dose-escalation Trial of SGN-75 in CD70-positive Non-Hodgkin Lymphoma or Renal Cell Carcinoma
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
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
Lead sponsor: Seagen Inc.
Sponsor class: INDUSTRY
First posted: 2009-11-18
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Incidence of adverse events and laboratory abnormalities
timeFrame: Through 1 month following last dose
Secondary outcomes:
measure: Best clinical response
timeFrame: Every 2 months
measure: Duration of response, progression-free survival
timeFrame: Every 3 months until progression of disease or initiation of new treatment for cancer
measure: Blood concentrations of SGN-75 and metabolites
timeFrame: Through 1 month following last dose
measure: Incidence of antitherapeutic antibodies
timeFrame: Through 1 month following last dose
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Duarte
country: United States
facility: City of Hope National Medical Center
state: California
city: Los Angeles
country: United States
facility: UCLA Medical Center / University of California at Los Angeles
state: California
city: Detroit
country: United States
facility: Karmanos Cancer Institute / Wayne State University
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Nashville
country: United States
facility: Sarah Cannon Research Institute
state: Tennessee
city: Houston
country: United States
facility: MD Anderson Cancer Center / University of Texas
state: Texas
city: Seattle
country: United States
facility: Seattle Cancer Care Alliance / University of Washington
state: Washington
Study officials:
affiliation: Seagen Inc.
name: Nancy Whiting, PharmD, BCOP
role: STUDY_DIRECTOR
References:
citation: 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.