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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03993379
Recruitment Status : Terminated (Sponsor's Decision)
First Posted : June 20, 2019
Results First Posted : December 1, 2021
Last Update Posted : December 1, 2021
Sponsor:
Information provided by (Responsible Party):
CytomX Therapeutics

Study Description
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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)

Condition or disease Intervention/treatment Phase
Solid Tumor Unresectable or Metastatic Melanoma Drug: CX-072 Drug: Ipilimumab Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : November 20, 2019
Actual Primary Completion Date : May 21, 2020
Actual Study Completion Date : May 21, 2020

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma
Drug Information available for: Ipilimumab

Arms and Interventions
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Arm Intervention/treatment
Experimental: CX-072 in combination with anti-cancer therapy-front line
histologically or cytologically confirmed solid tumor who have received no prior treatment
 Drug: CX-072
CX-072 in combination with ipilimumab
Experimental: CX-072 in combination with ipilimumab
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
CX-072 in combination with ipilimumab

Drug: Ipilimumab
CX-072 in combination with ipilimumab
Experimental: CX-072 in combination with anti-cancer therapy-Progressed
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
CX-072 in combination with ipilimumab
Experimental: CX-072 in combination with anti-cancer therapy-Neoadjuvant
neo-adjuvant study in subjects with histologically confirmed solid tumor
 Drug: CX-072
CX-072 in combination with ipilimumab


Outcome Measures
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Primary Outcome Measures :
  1. Overall Response Rate by RECIST v 1.1 [ Time Frame: 1 year ]
    ORR by RECIST v1.1


Secondary Outcome Measures :
  1. The Percentage of Patients Experiencing Treatment Related Adverse Events [ Time Frame: 2 years ]
    Safety and Tolerability of CX-072 in Combination Therapy

  2. The Numbers of Patients Experiencing Anti-tumor Activity by irRECIST [ Time Frame: 2 years ]
    ORR by irRECIST


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03993379


Locations
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Sponsors and Collaborators
CytomX Therapeutics
Investigators
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Study Director: Lawrence Lu, MD CytomX Therapeutics
  Study Documents (Full-Text)

Documents provided by CytomX Therapeutics:
Study Protocol  [PDF] August 21, 2019
No Statistical Analysis Plan (SAP) exists for this study.

More Information
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Responsible Party: CytomX Therapeutics
ClinicalTrials.gov Identifier: NCT03993379    
Other Study ID Numbers: CTMX-M-072-002
First Posted: June 20, 2019    Key Record Dates
Results First Posted: December 1, 2021
Last Update Posted: December 1, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by CytomX Therapeutics:
Combination
ipilimumab
Cancer
checkpoint inhibitor
PD-L1
 CTLA-4
PROCLAIM
PROCLAIM-CX-072
Relapsed
Refractory
Additional relevant MeSH terms:
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Neoplasms
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
 Skin Neoplasms
Neoplasms by Site
Skin Diseases
Ipilimumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action