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

NCT ID: NCT03993379

Last Updated: 2025-12-26

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-20

Study Completion Date

2020-05-21

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)

Detailed Description

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Conditions

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Solid Tumor Unresectable or Metastatic Melanoma

Keywords

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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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

histologically or cytologically confirmed solid tumor who have received no prior treatment

Group Type EXPERIMENTAL

CX-072

Intervention Type DRUG

CX-072 in combination with ipilimumab

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

Group Type EXPERIMENTAL

CX-072

Intervention Type DRUG

CX-072 in combination with ipilimumab

Ipilimumab

Intervention Type DRUG

CX-072 in combination with ipilimumab

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

Group Type EXPERIMENTAL

CX-072

Intervention Type DRUG

CX-072 in combination with ipilimumab

CX-072 in combination with anti-cancer therapy-Neoadjuvant

neo-adjuvant study in subjects with histologically confirmed solid tumor

Group Type EXPERIMENTAL

CX-072

Intervention Type DRUG

CX-072 in combination with ipilimumab

Interventions

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CX-072

CX-072 in combination with ipilimumab

Intervention Type DRUG

Ipilimumab

CX-072 in combination with ipilimumab

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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CytomX Therapeutics

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lawrence Lu, MD

Role: STUDY_DIRECTOR

CytomX Therapeutics

Locations

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City of Hope National Medical Center

Duarte, California, United States

Site Status

The Angeles Clinic and Research Institute

Los Angeles, California, United States

Site Status

Beacon Cancer Care

Coeur d'Alene, Idaho, United States

Site Status

University of Chicago

Chicago, Illinois, United States

Site Status

Norton Cancer Institute

Louisville, Kentucky, United States

Site Status

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Site Status

NYC Cancer Institute

New York, New York, United States

Site Status

Columbia Medical Center

New York, New York, United States

Site Status

Oregon Health & Science Center

Portland, Oregon, United States

Site Status

Providence Portland Medical Center

Portland, Oregon, United States

Site Status

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, United States

Site Status

Inova Dwight and March Schar Cancer Institute

Fairfax, Virginia, United States

Site Status

Virginia Cancer Specialists

Fairfax, Virginia, United States

Site Status

Multicare Institute for Research and Innovation

Spokane, Washington, United States

Site Status

Sunshine Coast University Private Hospital

Sunshine Coast, Queensland, Australia

Site Status

Ballarat Oncology and Haematology Services

Wendouree, Victoria, Australia

Site Status

The Netherlands Cancer Institute

Amsterdam, , Netherlands

Site Status

University Medical Center Groningen

Groningen, , Netherlands

Site Status

Asan Medical Center

Seoul, , South Korea

Site Status

Samsung Medical Center

Seoul, , South Korea

Site Status

Seoul National University Hospital

Seoul, , South Korea

Site Status

Severance Hospital Yonsei University Health System

Seoul, , South Korea

Site Status

ICO Hospitalet, Hospital Duran I Reynals

Barcelona, , Spain

Site Status

Hospital Clinic de Barcelona. Servicio Oncologia Medica

Barcelona, , Spain

Site Status

Hospital Universitario La Paz

Madrid, , Spain

Site Status

START- Madrid

Madrid, , Spain

Site Status

Clinica Universitaria de Navarra

Pamplona, , Spain

Site Status

Countries

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United States Australia Netherlands South Korea Spain

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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CTMX-M-072-002

Identifier Type: -

Identifier Source: org_study_id