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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

Primary Purpose

Solid Tumor, Unresectable or Metastatic Melanoma

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
CX-072
Ipilimumab
Sponsored by
CytomX Therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Solid Tumor focused on measuring Combination, ipilimumab, Cancer, checkpoint inhibitor, PD-L1, CTLA-4, PROCLAIM, PROCLAIM-CX-072, Relapsed, Refractory

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • City of Hope National Medical Center
  • The Angeles Clinic and Research Institute
  • Beacon Cancer Care
  • University of Chicago
  • Norton Cancer Institute
  • Dana Farber Cancer Institute
  • NYC Cancer Institute
  • Columbia Medical Center
  • Oregon Health & Science Center
  • Providence Portland Medical Center
  • UPMC Hillman Cancer Center
  • Inova Dwight and March Schar Cancer Institute
  • Virginia Cancer Specialists
  • Multicare Institute for Research and Innovation
  • Sunshine Coast University Private Hospital
  • Ballarat Oncology and Haematology Services
  • Asan Medical Center
  • Samsung Medical Center
  • Seoul National University Hospital
  • Severance Hospital Yonsei University Health System
  • The Netherlands Cancer Institute
  • University Medical Center Groningen
  • ICO Hospitalet, Hospital Duran I Reynals
  • Hospital Clinic de Barcelona. Servicio Oncologia Medica
  • Hospital Universitario La Paz
  • START- Madrid
  • Clinica Universitaria de Navarra

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

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

CX-072 in combination with ipilimumab

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

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

Arm Description

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

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

histologically or cytologically confirmed, advanced/unresectable or metastatic solid tumor that have experienced disease progression during or following treatment with platinum based therapy

neo-adjuvant study in subjects with histologically confirmed solid tumor

Outcomes

Primary Outcome Measures

Overall Response Rate by RECIST v 1.1
ORR by RECIST v1.1

Secondary Outcome Measures

The Percentage of Patients Experiencing Treatment Related Adverse Events
Safety and Tolerability of CX-072 in Combination Therapy
The Numbers of Patients Experiencing Anti-tumor Activity by irRECIST
ORR by irRECIST

Full Information

First Posted
May 14, 2019
Last Updated
November 2, 2021
Sponsor
CytomX Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT03993379
Brief Title
PROCLAIM: CX-072-002: Study of PD-L1 Probody Therapeutic CX-072 in Combination With Other Anticancer Therapy in Adults With Solid Tumors
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Terminated
Why Stopped
Sponsor's Decision
Study Start Date
November 20, 2019 (Actual)
Primary Completion Date
May 21, 2020 (Actual)
Study Completion Date
May 21, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CytomX Therapeutics

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Solid Tumor, Unresectable or Metastatic Melanoma
Keywords
Combination, ipilimumab, Cancer, checkpoint inhibitor, PD-L1, CTLA-4, PROCLAIM, PROCLAIM-CX-072, Relapsed, Refractory

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CX-072 in combination with anti-cancer therapy-front line
Arm Type
Experimental
Arm Description
histologically or cytologically confirmed solid tumor who have received no prior treatment
Arm Title
CX-072 in combination with ipilimumab
Arm Type
Experimental
Arm Description
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
Arm Title
CX-072 in combination with anti-cancer therapy-Progressed
Arm Type
Experimental
Arm Description
histologically or cytologically confirmed, advanced/unresectable or metastatic solid tumor that have experienced disease progression during or following treatment with platinum based therapy
Arm Title
CX-072 in combination with anti-cancer therapy-Neoadjuvant
Arm Type
Experimental
Arm Description
neo-adjuvant study in subjects with histologically confirmed solid tumor
Intervention Type
Drug
Intervention Name(s)
CX-072
Intervention Description
CX-072 in combination with ipilimumab
Intervention Type
Drug
Intervention Name(s)
Ipilimumab
Intervention Description
CX-072 in combination with ipilimumab
Primary Outcome Measure Information:
Title
Overall Response Rate by RECIST v 1.1
Description
ORR by RECIST v1.1
Time Frame
1 year
Secondary Outcome Measure Information:
Title
The Percentage of Patients Experiencing Treatment Related Adverse Events
Description
Safety and Tolerability of CX-072 in Combination Therapy
Time Frame
2 years
Title
The Numbers of Patients Experiencing Anti-tumor Activity by irRECIST
Description
ORR by irRECIST
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lawrence Lu, MD
Organizational Affiliation
CytomX Therapeutics
Official's Role
Study Director
Facility Information:
Facility Name
City of Hope National Medical Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Facility Name
The Angeles Clinic and Research Institute
City
Los Angeles
State/Province
California
ZIP/Postal Code
90025
Country
United States
Facility Name
Beacon Cancer Care
City
Coeur d'Alene
State/Province
Idaho
ZIP/Postal Code
83814
Country
United States
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Norton Cancer Institute
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
NYC Cancer Institute
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Columbia Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Oregon Health & Science Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Providence Portland Medical Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States
Facility Name
UPMC Hillman Cancer Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Facility Name
Inova Dwight and March Schar Cancer Institute
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Facility Name
Virginia Cancer Specialists
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Facility Name
Multicare Institute for Research and Innovation
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Facility Name
Sunshine Coast University Private Hospital
City
Sunshine Coast
State/Province
Queensland
Country
Australia
Facility Name
Ballarat Oncology and Haematology Services
City
Wendouree
State/Province
Victoria
Country
Australia
Facility Name
Asan Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Severance Hospital Yonsei University Health System
City
Seoul
Country
Korea, Republic of
Facility Name
The Netherlands Cancer Institute
City
Amsterdam
Country
Netherlands
Facility Name
University Medical Center Groningen
City
Groningen
Country
Netherlands
Facility Name
ICO Hospitalet, Hospital Duran I Reynals
City
Barcelona
ZIP/Postal Code
08908
Country
Spain
Facility Name
Hospital Clinic de Barcelona. Servicio Oncologia Medica
City
Barcelona
Country
Spain
Facility Name
Hospital Universitario La Paz
City
Madrid
Country
Spain
Facility Name
START- Madrid
City
Madrid
Country
Spain
Facility Name
Clinica Universitaria de Navarra
City
Pamplona
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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