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

Study Overview
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Brief Summary
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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)

Official Title
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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

Conditions
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Solid Tumor, Unresectable or Metastatic Melanoma

Intervention / Treatment
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* Drug: CX-072
* Drug: Ipilimumab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: At least 18 years of age Measurable disease as defined by RECIST v1.1 Eastern Cooperative Oncology Group (ECOG) performance status of ≤1 Agree to provide tumor tissue and blood samples for biomarker assessment Exclusion Criteria: Treatment with cytotoxic chemotherapy, biologic agents, radiation, immunotherapy, or any investigational agent within 28 days prior to the first dose of study treatment. Prior therapy with a chimeric antigen receptor T cell-containing regimen 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 History of myocarditis regardless of the cause History of intolerance to prior checkpoint inhibitor therapy defined as the need to discontinue treatment due to an irAE History of any syndrome or medical condition that required treatment with systemic steroids (≥10 mg daily prednisone equivalents) or immunosuppressive medications. History of severe allergic or anaphylactic reactions to human mAb therapy or known hypersensitivity to any Probody therapeutic

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CX-072 in combination with anti-cancer therapy-front line<br>histologically or cytologically confirmed solid tumor who have received no prior treatment | Drug: CX-072<br>* CX-072 in combination with ipilimumab<br>|
| Experimental: CX-072 in combination with ipilimumab<br>histologically or cytologically confirmed Stage III (unresectable) or Stage IV melanoma who have experienced progressive disease or relapse following treatment with a PD-1/PD-L1 immune checkpoint inhibitor | Drug: CX-072<br>* CX-072 in combination with ipilimumab<br>Drug: Ipilimumab<br>* CX-072 in combination with ipilimumab<br>|
| Experimental: CX-072 in combination with anti-cancer therapy-Progressed<br>histologically or cytologically confirmed, advanced/unresectable or metastatic solid tumor that have experienced disease progression during or following treatment with platinum based therapy | Drug: CX-072<br>* CX-072 in combination with ipilimumab<br>|
| Experimental: CX-072 in combination with anti-cancer therapy-Neoadjuvant<br>neo-adjuvant study in subjects with histologically confirmed solid tumor | Drug: CX-072<br>* CX-072 in combination with ipilimumab<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Response Rate by RECIST v 1.1 | ORR by RECIST v1.1 | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Percentage of Patients Experiencing Treatment Related Adverse Events | Safety and Tolerability of CX-072 in Combination Therapy | 2 years | 
| The Numbers of Patients Experiencing Anti-tumor Activity by irRECIST | ORR by irRECIST | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Combination, ipilimumab, Cancer, checkpoint inhibitor, PD-L1, CTLA-4, PROCLAIM, PROCLAIM-CX-072, Relapsed, Refractory