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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03993379
Recruitment Status : Recruiting
First Posted : June 20, 2019
Last Update Posted : September 13, 2019
Sponsor:
Information provided by (Responsible Party):
CytomX Therapeutics

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 Drug: CX-072 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 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 : September 12, 2019
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : January 2023

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 anticancer therapy

Experimental: CX-072 in combination with anti-cancer therapy-Relapsed
histologically or cytologically confirmed solid tumor who have experienced progressive disease or relapse following monotherapy with a PD-1/PD-L1 immune checkpoint inhibitor
Drug: CX-072
CX-072 in combination with anticancer therapy

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 anticancer therapy

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 anticancer therapy




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



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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

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


Contacts
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Contact: Gary Albert 650-528-2929 clinicaltrials@cytomx.com

Locations
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United States, Oregon
Providence Portland Medical Center Recruiting
Portland, Oregon, United States, 97213
United States, Virginia
Virginia Cancer Specialists Not yet recruiting
Fairfax, Virginia, United States, 22031
Sponsors and Collaborators
CytomX Therapeutics
Investigators
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Study Director: Yifah Yaron, MD CytomX Therapeutics

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Responsible Party: CytomX Therapeutics
ClinicalTrials.gov Identifier: NCT03993379     History of Changes
Other Study ID Numbers: CTMX-M-072-002
First Posted: June 20, 2019    Key Record Dates
Last Update Posted: September 13, 2019
Last Verified: June 2019
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
Additional relevant MeSH terms:
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Neoplasms