Clinical trial NCT03993379: PROCLAIM: CX-072-002: Study of PD-L1 Probody Therapeutic CX-072 in Combination With Other Anticancer Therapy in Adults With Solid Tumors
Official title: A Phase 2, Open-Label, Multi-cohort Study of PD-L1 Probody Therapeutic CX-072 in Combination With Other Anticancer Therapy in Adults With Solid Tumors
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Solid Tumor
Unresectable or Metastatic Melanoma
Keywords: Combination
ipilimumab
Cancer
checkpoint inhibitor
PD-L1
CTLA-4
PROCLAIM
PROCLAIM-CX-072
Relapsed
Refractory
Lead sponsor: CytomX Therapeutics
Sponsor class: INDUSTRY
First posted: 2019-06-20
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To obtain evidence of antitumor effect of CX-072 in combination with anticancer therapy in adult patients with solid tumor based upon overall response rate by Response Evaluation Criteria in Solid Tumors (RECIST)


Eligibility criteria: Inclusion Criteria:

1. At least 18 years of age
2. Measurable disease as defined by RECIST v1.1
3. Eastern Cooperative Oncology Group (ECOG) performance status of ≤1
4. Agree to provide tumor tissue and blood samples for biomarker assessment

Exclusion Criteria:

1. Treatment with cytotoxic chemotherapy, biologic agents, radiation, immunotherapy, or any investigational agent within 28 days prior to the first dose of study treatment.
2. Prior therapy with a chimeric antigen receptor T cell-containing regimen
3. History of active autoimmune disease(s) including but not limited to inflammatory bowel diseases, rheumatoid arthritis, autoimmune thyroiditis, autoimmune hepatitis, systemic sclerosis, systemic lupus erythematosus, autoimmune vasculitis, autoimmune neuropathies, type 1 insulin-dependent diabetes mellitus
4. History of myocarditis regardless of the cause
5. History of intolerance to prior checkpoint inhibitor therapy defined as the need to discontinue treatment due to an irAE
6. History of any syndrome or medical condition that required treatment with systemic steroids (≥10 mg daily prednisone equivalents) or immunosuppressive medications.
7. History of severe allergic or anaphylactic reactions to human mAb therapy or known hypersensitivity to any Probody therapeutic

Primary outcomes:
measure: Overall Response Rate by RECIST v 1.1
timeFrame: 1 year
Secondary outcomes:
measure: The Percentage of Patients Experiencing Treatment Related Adverse Events
timeFrame: 2 years
measure: The Numbers of Patients Experiencing Anti-tumor Activity by irRECIST
timeFrame: 2 years
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope National Medical Center
state: California
city: Los Angeles
country: United States
facility: The Angeles Clinic and Research Institute
state: California
city: Coeur d'Alene
country: United States
facility: Beacon Cancer Care
state: Idaho
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Louisville
country: United States
facility: Norton Cancer Institute
state: Kentucky
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
city: New York
country: United States
facility: NYC Cancer Institute
state: New York
city: New York
country: United States
facility: Columbia Medical Center
state: New York
city: Portland
country: United States
facility: Oregon Health & Science Center
state: Oregon
city: Portland
country: United States
facility: Providence Portland Medical Center
state: Oregon
city: Pittsburgh
country: United States
facility: UPMC Hillman Cancer Center
state: Pennsylvania
city: Fairfax
country: United States
facility: Inova Dwight and March Schar Cancer Institute
state: Virginia
city: Fairfax
country: United States
facility: Virginia Cancer Specialists
state: Virginia
city: Spokane
country: United States
facility: Multicare Institute for Research and Innovation
state: Washington
city: Sunshine Coast
country: Australia
facility: Sunshine Coast University Private Hospital
state: Queensland
city: Wendouree
country: Australia
facility: Ballarat Oncology and Haematology Services
state: Victoria
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital Yonsei University Health System
city: Amsterdam
country: Netherlands
facility: The Netherlands Cancer Institute
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
city: Barcelona
country: Spain
facility: ICO Hospitalet, Hospital Duran I Reynals
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona. Servicio Oncologia Medica
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Madrid
country: Spain
facility: START- Madrid
city: Pamplona
country: Spain
facility: Clinica Universitaria de Navarra
Study officials:
affiliation: CytomX Therapeutics
name: Lawrence Lu, MD
role: STUDY_DIRECTOR
References: