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

NCT03993379 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: CTMX-M-072-002
• Study Type: interventional
• Target: 3
• Locations: 5 countries
• Sites: 27

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)

Conditions

Unresectable or Metastatic Melanoma; Solid Tumor

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate by RECIST v 1.1

  ORR by RECIST v1.1

  1 year

Secondary Outcomes (2)

• The Percentage of Patients Experiencing Treatment Related Adverse Events

  2 years

• The Numbers of Patients Experiencing Anti-tumor Activity by irRECIST

  2 years

Study Arms (4)

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

EXPERIMENTAL

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

Drug: CX-072

CX-072 in combination with ipilimumab

EXPERIMENTAL

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; Drug: Ipilimumab

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

EXPERIMENTAL

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 anti-cancer therapy-Neoadjuvant

EXPERIMENTAL

neo-adjuvant study in subjects with histologically confirmed solid tumor

Drug: CX-072

Interventions

CX-072 DRUG

CX-072 in combination with ipilimumab

CX-072 in combination with anti-cancer therapy-Neoadjuvant; CX-072 in combination with anti-cancer therapy-Progressed; CX-072 in combination with anti-cancer therapy-front line; CX-072 in combination with ipilimumab

Ipilimumab DRUG

CX-072 in combination with ipilimumab

CX-072 in combination with ipilimumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• CytomX Therapeutics: lead

Study Sites (27)

City of Hope National Medical Center

Duarte, California, 91010, United States

Location

The Angeles Clinic and Research Institute

Los Angeles, California, 90025, United States

Location

Beacon Cancer Care

Coeur d'Alene, Idaho, 83814, United States

Location

University of Chicago

Chicago, Illinois, 60637, United States

Location

Norton Cancer Institute

Louisville, Kentucky, 40202, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

NYC Cancer Institute

New York, New York, 10016, United States

Location

Columbia Medical Center

New York, New York, 10032, United States

Location

Oregon Health & Science Center

Portland, Oregon, 97210, United States

Location

Providence Portland Medical Center

Portland, Oregon, 97213, United States

Location

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, 15232, United States

Location

Inova Dwight and March Schar Cancer Institute

Fairfax, Virginia, 22031, United States

Location

Virginia Cancer Specialists

Fairfax, Virginia, 22031, United States

Location

Multicare Institute for Research and Innovation

Spokane, Washington, 99204, United States

Location

Sunshine Coast University Private Hospital

Sunshine Coast, Queensland, Australia

Location

Ballarat Oncology and Haematology Services

Wendouree, Victoria, Australia

Location

The Netherlands Cancer Institute

Amsterdam, Netherlands

Location

University Medical Center Groningen

Groningen, Netherlands

Location

Asan Medical Center

Seoul, South Korea

Location

Samsung Medical Center

Seoul, South Korea

Location

Seoul National University Hospital

Seoul, South Korea

Location

Severance Hospital Yonsei University Health System

Seoul, South Korea

Location

ICO Hospitalet, Hospital Duran I Reynals

Barcelona, 08908, Spain

Location

Hospital Clinic de Barcelona. Servicio Oncologia Medica

Barcelona, Spain

Location

Hospital Universitario La Paz

Madrid, Spain

Location

START- Madrid

Madrid, Spain

Location

Clinica Universitaria de Navarra

Pamplona, Spain

Location

MeSH Terms

Conditions

Melanoma; Neoplasms; Diabetes Mellitus, Insulin-Dependent, 12; Recurrence

Interventions

Ipilimumab

Condition Hierarchy (Ancestors)

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; Skin and Connective Tissue Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Limitations and Caveats

Due to developmental strategic reasons and slow enrollment because of the COVID-19 pandemic, the study was terminated early. Three subjects were enrolled, all in Cohort A2. The last subject observation for this study was on 21 May 2020. Since the study terminated early, a statistical analysis plan was not generated.

Results Point of Contact

• Title: Lawrence Lu
• Organization: CytomX Therapeutics

clinicaltrials@cytomx.com

(650) 515-3185

Study Officials

• Lawrence Lu, MD

  CytomX Therapeutics

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2019
• First Posted: June 20, 2019
• Study Start: November 20, 2019
• Primary Completion: May 21, 2020
• Study Completion: May 21, 2020
• Last Updated: December 26, 2025
• Results First Posted: December 1, 2021

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

ES (5); AU (2); KR (4); US (14); NL (2)