PROCLAIM: CX-072-002: Study of PD-L1 Probody Therapeutic CX-072 in Combination With Other Anticancer Therapy in Adults With Solid Tumors

Solid Tumor Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03993379
• Other study ID #: CTMX-M-072-002
• Status: Terminated
• Phase: Phase 2
• Start date: November 20, 2019
• Est. completion date: May 21, 2020

Study information

• Verified date: November 2021
• Source: CytomX Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: May 21, 2020
• Est. primary completion date: May 21, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Melanoma
• Neoplasms
• Solid Tumor
• Unresectable or Metastatic Melanoma

Intervention

Drug:
• CX-072
CX-072 in combination with ipilimumab
• Ipilimumab
CX-072 in combination with ipilimumab

Locations

Country	Name	City	State
Australia	Sunshine Coast University Private Hospital	Sunshine Coast	Queensland
Australia	Ballarat Oncology and Haematology Services	Wendouree	Victoria
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Severance Hospital Yonsei University Health System	Seoul
Netherlands	The Netherlands Cancer Institute	Amsterdam
Netherlands	University Medical Center Groningen	Groningen
Spain	Hospital Clinic de Barcelona. Servicio Oncologia Medica	Barcelona
Spain	ICO Hospitalet, Hospital Duran I Reynals	Barcelona
Spain	Hospital Universitario La Paz	Madrid
Spain	START- Madrid	Madrid
Spain	Clinica Universitaria de Navarra	Pamplona
United States	Dana Farber Cancer Institute	Boston	Massachusetts
United States	University of Chicago	Chicago	Illinois
United States	Beacon Cancer Care	Coeur d'Alene	Idaho
United States	City of Hope National Medical Center	Duarte	California
United States	Inova Dwight and March Schar Cancer Institute	Fairfax	Virginia
United States	Virginia Cancer Specialists	Fairfax	Virginia
United States	The Angeles Clinic and Research Institute	Los Angeles	California
United States	Norton Cancer Institute	Louisville	Kentucky
United States	Columbia Medical Center	New York	New York
United States	NYC Cancer Institute	New York	New York
United States	UPMC Hillman Cancer Center	Pittsburgh	Pennsylvania
United States	Oregon Health & Science Center	Portland	Oregon
United States	Providence Portland Medical Center	Portland	Oregon
United States	Multicare Institute for Research and Innovation	Spokane	Washington

Sponsors (1)

Lead Sponsor	Collaborator
CytomX Therapeutics

Countries where clinical trial is conducted

United States,  Australia,  Korea, Republic of,  Netherlands,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Response Rate by RECIST v 1.1	ORR by RECIST v1.1	1 year
Secondary	The Percentage of Patients Experiencing Treatment Related Adverse Events	Safety and Tolerability of CX-072 in Combination Therapy	2 years
Secondary	The Numbers of Patients Experiencing Anti-tumor Activity by irRECIST	ORR by irRECIST	2 years