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

NCT03993379

Description:

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)

Related Conditions:
  • Malignant Solid Tumor
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: 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

Clinical Trial IDs

  • ORG STUDY ID: CTMX-M-072-002
  • NCT ID: NCT03993379

Conditions

  • Solid Tumor

Interventions

DrugSynonymsArms
CX-072CX-072 in combination with anti-cancer therapy-front line

Purpose

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)

Trial Arms

NameTypeDescriptionInterventions
CX-072 in combination with anti-cancer therapy-front lineExperimentalhistologically or cytologically confirmed solid tumor who have received no prior treatment
  • CX-072
CX-072 in combination with anti-cancer therapy-RelapsedExperimentalhistologically or cytologically confirmed solid tumor who have experienced progressive disease or relapse following monotherapy with a PD-1/PD-L1 immune checkpoint inhibitor
  • CX-072
CX-072 in combination with anti-cancer therapy-ProgressedExperimentalhistologically or cytologically confirmed, advanced/unresectable or metastatic solid tumor that have experienced disease progression during or following treatment with platinum based therapy
  • CX-072
CX-072 in combination with anti-cancer therapy-NeoadjuvantExperimentalneo-adjuvant study in subjects with histologically confirmed solid tumor
  • CX-072

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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Overall response rate by RECIST v 1,1
Time Frame:1 year
Safety Issue:
Description:ORR by RECIST v1.1

Secondary Outcome Measures

Measure:The percentage of patients experiencing Treatment Related Adverse Events
Time Frame:2 years
Safety Issue:
Description:Safety and Tolerability of CX-072 in Combination Therapy
Measure:The numbers of patients experiencing anti-tumor activity by irRECIST
Time Frame:2 years
Safety Issue:
Description:ORR by irRECIST

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:CytomX Therapeutics

Trial Keywords

  • Combination
  • ipilimumab
  • Cancer
  • checkpoint inhibitor
  • PD-L1
  • CTLA-4
  • PROCLAIM
  • PROCLAIM-CX-072

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