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PROCLAIM-CX-072: A Trial to Find Safe and Active Doses of an Investigational Drug CX-072 for Patients With Solid Tumors or Lymphomas

Primary Purpose

Solid Tumor, Lymphoma

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
CX-072
ipilimumab
vemurafenib
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 cancer, checkpoint inhibitor, monotherapy, combination, PD-L1, CTLA-4, solid tumor, lymphoma, BRAF, PROCLAIM, CX-072, PROCLAIM-CX-072

Eligibility Criteria

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

Inclusion Criteria:

  1. Histologically confirmed diagnosis of metastatic or advanced unresectable tumors that progressed on standard therapy
  2. Agreement to provide mandatory archival tissue or fresh biopsy.
  3. At least 18 years of age.

Exclusion Criteria:

  1. Prior therapy with a chimeric antigen receptor (CAR) T-cell containing regimen.
  2. History of severe allergic or anaphylactic reactions to human monoclonal antibody therapy or known hypersensitivity to any Probody therapeutic.
  3. Active or history of uveal, mucosal, or ocular melanoma. Human immunodeficiency virus (HIV) or acquired immune deficiency syndrome (AIDS)-related illness, chronic hepatitis B or C.
  4. History of or current active autoimmune diseases, including but not limited to inflammatory bowel diseases, rheumatoid arthritis, autoimmune thyroiditis, autoimmune hepatitis, systemic sclerosis, systemic lupus erythematosus, autoimmune vasculitis, autoimmune neuropathies, or type 1 insulin dependent diabetes mellitus.
  5. History of syndrome or medical condition(s) that requires systemic steroids (> 10 mg daily prednisone equivalents) or immunosuppressive medications.
  6. History of allogeneic tissue/solid organ transplant, prior stem cell or bone marrow transplant.
  7. Chemotherapy, biochemotherapy, radiation or immunotherapy or any investigational treatment within 30 days prior to receiving any study drug.
  8. Major surgery (requiring general anesthesia) within 3 months or minor surgery (excluding biopsies conducted with local/topical anesthesia) or gamma knife treatment within 14 days (with adequate healing) of administration of any study drug.

Sites / Locations

  • PROCLAIM Investigative Site
  • PROCLAIM Investigative Site
  • PROCLAIM Investigative Site
  • PROCLAIM Investigative Site
  • PROCLAIM Investigative Site
  • PROCLAIM Investigative Site
  • PROCLAIM Investigative Site
  • PROCLAIM Investigative Site
  • PROCLAIM Investigative Site
  • PROCLAIM Investigative Site
  • PROCLAIM Investigative Site
  • PROCLAIM Investigative Site
  • PROCLAIM Investigative Site
  • PROCLAIM Investigative Site
  • PROCLAIM Investigative Site
  • PROCLAIM Investigative Site
  • PROCLAIM Investigative Site
  • PROCLAIM Investigative Site
  • PROCLAIM Investigative Site
  • PROCLAIM Investigative Site
  • PROCLAIM Investigative Site
  • PROCLAIM Investigative Site
  • PROCLAIM Investigative Site
  • PROCLAIM Investigative Site
  • PROCLAIM Investigative Site
  • PROCLAIM Investigative Ssite
  • PROCLAIM Investigative Site
  • PROCLAIM Invetigative Site
  • PROCLAIM Investigative Site
  • PROCLAIM Investigative Site
  • PROCLAIM Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

CX-072

CX-072 with Ipilimumab #1

CX-072 with Ipilimumab #2

CX-072 with Vemurafenib

CX-072 expansion

Arm Description

Monotherapy CX-072

Combination CX-072 + ipilimumab (Schedule 1)

Combination CX-072 + ipilimumab (Schedule 2)

Combination CX-072 + vemurafenib

Monotherapy CX-072

Outcomes

Primary Outcome Measures

The number of subjects experiencing a dose limiting toxicity at various dose levels when given multiple doses of CX-072 as a monotherapy or in combination with ipilimumab or vemurafenib

Secondary Outcome Measures

The percentage of subjects experiencing anti-cancer activity (ORR) at various dose levels when given multiple doses of CX-072 as a monotherapy or in combination with ipilimumab or vemurafenib

Full Information

First Posted
December 26, 2016
Last Updated
February 7, 2022
Sponsor
CytomX Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT03013491
Brief Title
PROCLAIM-CX-072: A Trial to Find Safe and Active Doses of an Investigational Drug CX-072 for Patients With Solid Tumors or Lymphomas
Official Title
An Open-Label, Dose-Finding and Proof of Concept Study of the PD-L1 Probody™ Therapeutic , CX-072, as Monotherapy and in Combination With Yervoy (Ipilimumab) or With Zelboraf (Vemurafenib) in Subjects With Advanced or Recurrent Solid Tumors or Lymphomas
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
January 2017 (undefined)
Primary Completion Date
October 6, 2021 (Actual)
Study Completion Date
October 6, 2021 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

5. Study Description

Brief Summary
The purpose of this first-in-human study of CX-072 is to characterize the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and antitumor activity of CX-072 administered intravenously (IV) as a single agent or in combination with ipilimumab or vemurafenib in adult subjects with advanced or recurrent solid tumors or lymphomas. PROCLAIM-CX-072: PRObody CLinical Assessment In Man CX-072 clinical trial CX-072 is a Probody™ therapeutic directed against PD-L1 (programmed cell death ligand 1). Probody therapeutics are proteolytically-activatable antibodies (Abs) designed to widen the therapeutic index by minimizing drug interaction with normal tissue while retaining anti-tumor activity. Probody therapeutics are "masked" to attenuate binding to target in healthy tissue but can become "unmasked" in the tumor microenvironment by tumor-specific protease activity. PROBODY is a trademark of CytomX Therapeutics, Inc.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Solid Tumor, Lymphoma
Keywords
cancer, checkpoint inhibitor, monotherapy, combination, PD-L1, CTLA-4, solid tumor, lymphoma, BRAF, PROCLAIM, CX-072, PROCLAIM-CX-072

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CX-072
Arm Type
Experimental
Arm Description
Monotherapy CX-072
Arm Title
CX-072 with Ipilimumab #1
Arm Type
Experimental
Arm Description
Combination CX-072 + ipilimumab (Schedule 1)
Arm Title
CX-072 with Ipilimumab #2
Arm Type
Experimental
Arm Description
Combination CX-072 + ipilimumab (Schedule 2)
Arm Title
CX-072 with Vemurafenib
Arm Type
Experimental
Arm Description
Combination CX-072 + vemurafenib
Arm Title
CX-072 expansion
Arm Type
Experimental
Arm Description
Monotherapy CX-072
Intervention Type
Drug
Intervention Name(s)
CX-072
Intervention Type
Drug
Intervention Name(s)
ipilimumab
Intervention Type
Drug
Intervention Name(s)
vemurafenib
Primary Outcome Measure Information:
Title
The number of subjects experiencing a dose limiting toxicity at various dose levels when given multiple doses of CX-072 as a monotherapy or in combination with ipilimumab or vemurafenib
Time Frame
28 days (dose limiting toxicity period)
Secondary Outcome Measure Information:
Title
The percentage of subjects experiencing anti-cancer activity (ORR) at various dose levels when given multiple doses of CX-072 as a monotherapy or in combination with ipilimumab or vemurafenib
Time Frame
2 Years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically confirmed diagnosis of metastatic or advanced unresectable tumors that progressed on standard therapy Agreement to provide mandatory archival tissue or fresh biopsy. At least 18 years of age. Exclusion Criteria: Prior therapy with a chimeric antigen receptor (CAR) T-cell containing regimen. History of severe allergic or anaphylactic reactions to human monoclonal antibody therapy or known hypersensitivity to any Probody therapeutic. Active or history of uveal, mucosal, or ocular melanoma. Human immunodeficiency virus (HIV) or acquired immune deficiency syndrome (AIDS)-related illness, chronic hepatitis B or C. History of or current active autoimmune diseases, including but not limited to inflammatory bowel diseases, rheumatoid arthritis, autoimmune thyroiditis, autoimmune hepatitis, systemic sclerosis, systemic lupus erythematosus, autoimmune vasculitis, autoimmune neuropathies, or type 1 insulin dependent diabetes mellitus. History of syndrome or medical condition(s) that requires systemic steroids (> 10 mg daily prednisone equivalents) or immunosuppressive medications. History of allogeneic tissue/solid organ transplant, prior stem cell or bone marrow transplant. Chemotherapy, biochemotherapy, radiation or immunotherapy or any investigational treatment within 30 days prior to receiving any study drug. Major surgery (requiring general anesthesia) within 3 months or minor surgery (excluding biopsies conducted with local/topical anesthesia) or gamma knife treatment within 14 days (with adequate healing) of administration of any study drug.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lawrence Lu, M.D.
Organizational Affiliation
CytomX Therapeutics
Official's Role
Study Director
Facility Information:
Facility Name
PROCLAIM Investigative Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90025
Country
United States
Facility Name
PROCLAIM Investigative Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
PROCLAIM Investigative Site
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
Facility Name
PROCLAIM Investigative Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
PROCLAIM Investigative Site
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
PROCLAIM Investigative Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
PROCLAIM Investigative Site
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
PROCLAIM Investigative Site
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
PROCLAIM Investigative Site
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
PROCLAIM Investigative Site
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
PROCLAIM Investigative Site
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States
Facility Name
PROCLAIM Investigative Site
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
PROCLAIM Investigative Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
PROCLAIM Investigative Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
PROCLAIM Investigative Site
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Facility Name
PROCLAIM Investigative Site
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53579
Country
United States
Facility Name
PROCLAIM Investigative Site
City
Amsterdam
ZIP/Postal Code
1007
Country
Netherlands
Facility Name
PROCLAIM Investigative Site
City
Groningen
ZIP/Postal Code
9713 GZ
Country
Netherlands
Facility Name
PROCLAIM Investigative Site
City
Rotterdam
ZIP/Postal Code
3000 CA
Country
Netherlands
Facility Name
PROCLAIM Investigative Site
City
Katowice
ZIP/Postal Code
40-960
Country
Poland
Facility Name
PROCLAIM Investigative Site
City
Pamplona
State/Province
Navarre
ZIP/Postal Code
31008
Country
Spain
Facility Name
PROCLAIM Investigative Site
City
Barcelona
ZIP/Postal Code
08908
Country
Spain
Facility Name
PROCLAIM Investigative Site
City
Barcelona
ZIP/Postal Code
8036
Country
Spain
Facility Name
PROCLAIM Investigative Site
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
PROCLAIM Investigative Site
City
Madrid
ZIP/Postal Code
28050
Country
Spain
Facility Name
PROCLAIM Investigative Ssite
City
Valencia
ZIP/Postal Code
46009
Country
Spain
Facility Name
PROCLAIM Investigative Site
City
Dnepropetrovsk
ZIP/Postal Code
49102
Country
Ukraine
Facility Name
PROCLAIM Invetigative Site
City
Glasgow
ZIP/Postal Code
G12 0YN
Country
United Kingdom
Facility Name
PROCLAIM Investigative Site
City
London
ZIP/Postal Code
W1G 6AD
Country
United Kingdom
Facility Name
PROCLAIM Investigative Site
City
Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Facility Name
PROCLAIM Investigative Site
City
Newcastle upon Tyne
ZIP/Postal Code
NE7 7DN
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
34301809
Citation
Naing A, Thistlethwaite F, De Vries EGE, Eskens FALM, Uboha N, Ott PA, LoRusso P, Garcia-Corbacho J, Boni V, Bendell J, Autio KA, Randhawa M, Durm G, Gil-Martin M, Stroh M, Hannah AL, Arkenau HT, Spira A. CX-072 (pacmilimab), a Probody (R) PD-L1 inhibitor, in advanced or recurrent solid tumors (PROCLAIM-CX-072): an open-label dose-finding and first-in-human study. J Immunother Cancer. 2021 Jul;9(7):e002447. doi: 10.1136/jitc-2021-002447.
Results Reference
derived
PubMed Identifier
34301808
Citation
Sanborn RE, Hamid O, de Vries EG, Ott PA, Garcia-Corbacho J, Boni V, Bendell J, Autio KA, Cho DC, Plummer R, Stroh M, Lu L, Thistlethwaite F. CX-072 (pacmilimab), a Probody PD-L1 inhibitor, in combination with ipilimumab in patients with advanced solid tumors (PROCLAIM-CX-072): a first-in-human, dose-finding study. J Immunother Cancer. 2021 Jul;9(7):e002446. doi: 10.1136/jitc-2021-002446.
Results Reference
derived
PubMed Identifier
31953313
Citation
Giesen D, Broer LN, Lub-de Hooge MN, Popova I, Howng B, Nguyen M, Vasiljeva O, de Vries EGE, Pool M. Probody Therapeutic Design of 89Zr-CX-072 Promotes Accumulation in PD-L1-Expressing Tumors Compared to Normal Murine Lymphoid Tissue. Clin Cancer Res. 2020 Aug 1;26(15):3999-4009. doi: 10.1158/1078-0432.CCR-19-3137. Epub 2020 Jan 17.
Results Reference
derived

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PROCLAIM-CX-072: A Trial to Find Safe and Active Doses of an Investigational Drug CX-072 for Patients With Solid Tumors or Lymphomas

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