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Solid TumorPhase 1/2NCT03013491

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

A Phase 1/2 study testing CX-072, ipilimumab and vemurafenib in people with Solid Tumor and Lymphoma, run by CytomX Therapeutics at 31 sites in 6 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Solid Tumor, Lymphoma
What is being tested?
CX-072, ipilimumab and vemurafenib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
196 participants
Where
31 sitesin 6 countries
Study dates
19 Jan 2017to 27 Oct 2020
Phase
Phase 1/2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

31 sites in 6 countries.

31 sites in 6 countries

United States16 sites
  • PROCLAIM Investigative Site

    Boston, Massachusetts, 02215

  • PROCLAIM Investigative Site

    Chicago, Illinois, 60612

  • PROCLAIM Investigative Site

    Dallas, Texas, 75230

  • PROCLAIM Investigative Site

    Detroit, Michigan, 48201

  • PROCLAIM Investigative Site

    Fairfax, Virginia, 22031

  • PROCLAIM Investigative Site

    Houston, Texas, 77030

  • PROCLAIM Investigative Site

    Indianapolis, Indiana, 46202

  • PROCLAIM Investigative Site

    Los Angeles, California, 90025

  • PROCLAIM Investigative Site

    Los Angeles, California, 90033

  • PROCLAIM Investigative Site

    Madison, Wisconsin, 53579

  • PROCLAIM Investigative Site

    Nashville, Tennessee, 37203

  • PROCLAIM Investigative Site

    New Haven, Connecticut, 06520

  • PROCLAIM Investigative Site

    New York, New York, 10016

  • PROCLAIM Investigative Site

    New York, New York, 10032

  • PROCLAIM Investigative Site

    New York, New York, 10065

  • PROCLAIM Investigative Site

    Portland, Oregon, 97213

Other trials in United States

Spain6 sites
  • PROCLAIM Investigative Site

    Barcelona, 08908

  • PROCLAIM Investigative Site

    Barcelona, 8036

  • PROCLAIM Investigative Site

    Madrid, 28046

  • PROCLAIM Investigative Site

    Madrid, 28050

  • PROCLAIM Investigative Site

    Pamplona, Navarre, 31008

  • PROCLAIM Investigative Ssite

    Valencia, 46009

Other trials in Spain

United Kingdom4 sites
  • PROCLAIM Invetigative Site

    Glasgow, G12 0YN

  • PROCLAIM Investigative Site

    London, W1G 6AD

  • PROCLAIM Investigative Site

    Manchester, M20 4BX

  • PROCLAIM Investigative Site

    Newcastle upon Tyne, NE7 7DN

Other trials in United Kingdom

Netherlands3 sites
  • PROCLAIM Investigative Site

    Amsterdam, 1007

  • PROCLAIM Investigative Site

    Groningen, 9713 GZ

  • PROCLAIM Investigative Site

    Rotterdam, 3000 CA

Other trials in Netherlands

Poland1 site
  • PROCLAIM Investigative Site

    Katowice, 40-960

Other trials in Poland

Ukraine1 site
  • PROCLAIM Investigative Site

    Dnipro, 49102

Other trials in Ukraine

About this study

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

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.

Being tested
CX-072, ipilimumab, vemurafenib
Keywords
cancer, checkpoint inhibitor, monotherapy, combination, PD-L1, CTLA-4, solid tumor, lymphoma, BRAF, PROCLAIM, CX-072, PROCLAIM-CX-072
Medical subject headings
Lymphoma, Neoplasms, Diabetes Mellitus, Insulin-Dependent, 12

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CX-072Drug

    Solution for infusion

  • ipilimumabDrug

    Solution for infusion

  • vemurafenibDrug

    Tablet

Study groups in NCT03013491
Study groupRoleWhat they receive
CX-072 #1ExperimentalMonotherapy CX-072 (Part A)
Receives: Drug: CX-072
CX-072 #2ExperimentalMonotherapy CX-072 (Part A2)
Receives: Drug: CX-072
CX-072 with Ipilimumab #1ExperimentalCombination CX-072 + ipilimumab (Part B1)
Receives: Drug: CX-072; Drug: ipilimumab
CX-072 with Ipilimumab #2ExperimentalCombination CX-072 + ipilimumab (Part B2)
Receives: Drug: CX-072; Drug: ipilimumab
CX-072 with VemurafenibExperimentalCombination CX-072 + vemurafenib (Part C)
Receives: Drug: CX-072; Drug: vemurafenib
CX-072 expansionExperimentalMonotherapy CX-072 (Part D)
Receives: Drug: CX-072
CX-072 long-term extensionExperimentalMonotherapy CX-072
Receives: Drug: CX-072

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    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

    Measured: 28 days (dose limiting toxicity period)

Secondary outcomes (1)
  1. The Percentage of Subjects Experiencing Anti-cancer Activity (ORR) When Given 10 mg/kg CX-072 as Monotherapy

    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.

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jan 2017 (estimated)
  2. Study start19 Jan 2017
  3. Primary completion27 Oct 2020
  4. Study completion27 Oct 2020

Why it stopped: Sponsor's decision

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
196 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03013491
Sponsor's protocol ID
CTMX-M-072-001
Status last verified
May 2025
First submitted
26 Dec 2016
Last updated
17 Jun 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • 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.

    PubMed 34301809
  • 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.

    PubMed 34301808
  • 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.

    PubMed 31953313

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing CX-072, ipilimumab and vemurafenib in people with Solid Tumor and Lymphoma, run by CytomX Therapeutics at 31 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 17 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 31 sites in United States, Spain, United Kingdom, Netherlands, Poland and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03013491, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2025.

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Clinical Trial NCT03013491 | AzTrials