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

• Status: Terminated
• Trial end date: 2020-05-21
• Target enrollment: 0
• Participant gender: All

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)

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: CytomX Therapeutics
• Treatments: Ipilimumab

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