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

May 30, 2025 updated by: CytomX Therapeutics

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

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 U.S. registered trademark of CytomX Therapeutics, Inc.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

196

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Amsterdam, Netherlands, 1007
        • PROCLAIM Investigative Site
      • Groningen, Netherlands, 9713 GZ
        • PROCLAIM Investigative Site
      • Rotterdam, Netherlands, 3000 CA
        • PROCLAIM Investigative Site
  • Poland
      • Katowice, Poland, 40-960
        • PROCLAIM Investigative Site
  • Spain
      • Barcelona, Spain, 08908
        • PROCLAIM Investigative Site
      • Barcelona, Spain, 8036
        • PROCLAIM Investigative Site
      • Madrid, Spain, 28046
        • PROCLAIM Investigative Site
      • Madrid, Spain, 28050
        • PROCLAIM Investigative Site
      • Valencia, Spain, 46009
        • PROCLAIM Investigative Ssite
    • Navarre
      • Pamplona, Navarre, Spain, 31008
        • PROCLAIM Investigative Site
  • Ukraine
      • Dnepropetrovsk, Ukraine, 49102
        • PROCLAIM Investigative Site
  • United Kingdom
      • Glasgow, United Kingdom, G12 0YN
        • PROCLAIM Invetigative Site
      • London, United Kingdom, W1G 6AD
        • PROCLAIM Investigative Site
      • Manchester, United Kingdom, M20 4BX
        • PROCLAIM Investigative Site
      • Newcastle upon Tyne, United Kingdom, NE7 7DN
        • PROCLAIM Investigative Site
  • United States
    • California
      • Los Angeles, California, United States, 90025
        • PROCLAIM Investigative Site
      • Los Angeles, California, United States, 90033
        • PROCLAIM Investigative Site
    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • PROCLAIM Investigative Site
    • Illinois
      • Chicago, Illinois, United States, 60612
        • PROCLAIM Investigative Site
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • PROCLAIM Investigative Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • PROCLAIM Investigative Site
    • Michigan
      • Detroit, Michigan, United States, 48201
        • PROCLAIM Investigative Site
    • New York
      • New York, New York, United States, 10016
        • PROCLAIM Investigative Site
      • New York, New York, United States, 10032
        • PROCLAIM Investigative Site
      • New York, New York, United States, 10065
        • PROCLAIM Investigative Site
    • Oregon
      • Portland, Oregon, United States, 97213
        • PROCLAIM Investigative Site
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • PROCLAIM Investigative Site
    • Texas
      • Dallas, Texas, United States, 75230
        • PROCLAIM Investigative Site
      • Houston, Texas, United States, 77030
        • PROCLAIM Investigative Site
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • PROCLAIM Investigative Site
    • Wisconsin
      • Madison, Wisconsin, United States, 53579
        • PROCLAIM Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CX-072 #1
Monotherapy CX-072 (Part A)
Drug: CX-072
Solution for infusion
Experimental: CX-072 #2
Monotherapy CX-072 (Part A2)
Drug: CX-072
Solution for infusion
Experimental: CX-072 with Ipilimumab #1
Combination CX-072 + ipilimumab (Part B1)
Drug: CX-072
Solution for infusion
Drug: ipilimumab
Solution for infusion
Experimental: CX-072 with Ipilimumab #2
Combination CX-072 + ipilimumab (Part B2)
Drug: CX-072
Solution for infusion
Drug: ipilimumab
Solution for infusion
Experimental: CX-072 with Vemurafenib
Combination CX-072 + vemurafenib (Part C)
Drug: CX-072
Solution for infusion
Drug: vemurafenib
Tablet
Experimental: CX-072 expansion
Monotherapy CX-072 (Part D)
Drug: CX-072
Solution for infusion
Experimental: CX-072 long-term extension
Monotherapy CX-072
Drug: CX-072
Solution for infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Number of Subjects Experiencing a Dose Limiting Toxicity (DLT) 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)

Adverse events (AEs) that were considered DLTs:

  • Grade 5 AEs

  • Grade 4 AEs judged by the Investigator to be treatment-related or judged by the Sponsor as a DLT, regardless of Investigator-attribution (with some exceptions)

    • Any Grade 4 endocrinopathy.

  • Grade 3 AEs judged by the Investigator to be treatment-related or by the Sponsor, regardless of Investigator-attribution (with some exceptions)

    • Any Grade 3 central nervous system event, regardless of duration or reversibility.

  • Grade 2 pneumonitis necessitating CX-072 discontinuation
  • Grade 2 ocular toxicity necessitating CX-072 discontinuation
28 days (dose limiting toxicity period)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Percentage of Subjects Experiencing Anti-cancer Activity (ORR) When Given 10 mg/kg CX-072 as Monotherapy
Time Frame: 2 years
The primary efficacy endpoint, ORR, was defined as the proportion of subjects with complete response (CR) or partial response (PR) on two consecutive tumor assessments according to RECIST v1.1.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CytomX Therapeutics

Investigators

  • Study Director: Monika Vainorius, M.D., CytomX Therapeutics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 19, 2017

Primary Completion (Actual)

October 27, 2020

Study Completion (Actual)

October 27, 2020

Study Registration Dates

First Submitted

December 26, 2016

First Submitted That Met QC Criteria

January 5, 2017

First Posted (Estimated)

January 6, 2017

Study Record Updates

Last Update Posted (Actual)

June 17, 2025

Last Update Submitted That Met QC Criteria

May 30, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTMX-M-072-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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