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

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

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)

Study Overview

• Status: Terminated
• Conditions: Solid Tumor; Unresectable or Metastatic Melanoma
• Intervention / Treatment: Drug: CX-072; Drug: Ipilimumab

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Phase 2

Contacts and Locations

Study Locations

• Australia
  • Queensland
    • Sunshine Coast, Queensland, Australia
      • Sunshine Coast University Private Hospital
  • Victoria
    • Wendouree, Victoria, Australia
      • Ballarat Oncology and Haematology Services
• Korea, Republic of
  • Seoul, Korea, Republic of
    • Seoul National University Hospital
  • Seoul, Korea, Republic of
    • Asan Medical Center
  • Seoul, Korea, Republic of
    • Samsung Medical Center
  • Seoul, Korea, Republic of
    • Severance Hospital Yonsei University Health System
• Netherlands
  • Amsterdam, Netherlands
    • The Netherlands Cancer Institute
  • Groningen, Netherlands
    • University Medical Center Groningen
• Spain
  • Barcelona, Spain, 08908
    • ICO Hospitalet, Hospital Duran i Reynals
  • Barcelona, Spain
    • Hospital Clinic de Barcelona. Servicio Oncologia Medica
  • Madrid, Spain
    • Hospital Universitario La Paz
  • Madrid, Spain
    • START- Madrid
  • Pamplona, Spain
    • Clinica Universitaria de Navarra
• United States
  • California
    • Duarte, California, United States, 91010
      • City of Hope National Medical Center
    • Los Angeles, California, United States, 90025
      • The Angeles Clinic and Research Institute
  • Idaho
    • Coeur d'Alene, Idaho, United States, 83814
      • Beacon Cancer Care
  • Illinois
    • Chicago, Illinois, United States, 60637
      • University of Chicago
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • Norton Cancer Institute
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Dana Farber Cancer Institute
  • New York
    • New York, New York, United States, 10016
      • NYC Cancer Institute
    • New York, New York, United States, 10032
      • Columbia Medical Center
  • Oregon
    • Portland, Oregon, United States, 97213
      • Providence Portland Medical Center
    • Portland, Oregon, United States, 97210
      • Oregon Health & Science Center
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15232
      • UPMC Hillman Cancer Center
  • Virginia
    • Fairfax, Virginia, United States, 22031
      • Inova Dwight and March Schar Cancer Institute
    • Fairfax, Virginia, United States, 22031
      • Virginia Cancer Specialists
  • Washington
    • Spokane, Washington, United States, 99204
      • Multicare Institute for Research and Innovation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Response Rate by RECIST v 1.1	ORR by RECIST v1.1	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Percentage of Patients Experiencing Treatment Related Adverse Events	Safety and Tolerability of CX-072 in Combination Therapy	2 years
The Numbers of Patients Experiencing Anti-tumor Activity by irRECIST	ORR by irRECIST	2 years

Collaborators and Investigators

• Sponsor: CytomX Therapeutics
• Investigators: Study Director: Lawrence Lu, MD, CytomX Therapeutics

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2019
• Primary Completion (Actual): May 21, 2020
• Study Completion (Actual): May 21, 2020

Study Registration Dates

• First Submitted: May 14, 2019
• First Submitted That Met QC Criteria: June 19, 2019
• First Posted (Actual): June 20, 2019

Study Record Updates

• Last Update Posted (Actual): December 1, 2021
• Last Update Submitted That Met QC Criteria: November 2, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: Cancer; Relapsed; Refractory; PD-L1; Combination; checkpoint inhibitor; ipilimumab; CTLA-4; PROCLAIM; PROCLAIM-CX-072
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Nevi and Melanomas; Neoplasms; Melanoma; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Antineoplastic Agents, Immunological; Immune Checkpoint Inhibitors; Ipilimumab
• Other Study ID Numbers: CTMX-M-072-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No