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.
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
- Type of treatment
- Pill or oral medicine, Injection or infusion
- 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
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
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
Netherlands3 sites
PROCLAIM Investigative Site
Amsterdam, 1007
PROCLAIM Investigative Site
Groningen, 9713 GZ
PROCLAIM Investigative Site
Rotterdam, 3000 CA
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.
- Conditions
- Solid Tumor, Lymphoma
- 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 group | Role | What they receive |
|---|---|---|
| CX-072 #1 | Experimental | Monotherapy CX-072 (Part A) Receives: Drug: CX-072 |
| CX-072 #2 | Experimental | Monotherapy CX-072 (Part A2) Receives: Drug: CX-072 |
| CX-072 with Ipilimumab #1 | Experimental | Combination CX-072 + ipilimumab (Part B1) Receives: Drug: CX-072; Drug: ipilimumab |
| CX-072 with Ipilimumab #2 | Experimental | Combination CX-072 + ipilimumab (Part B2) Receives: Drug: CX-072; Drug: ipilimumab |
| CX-072 with Vemurafenib | Experimental | Combination CX-072 + vemurafenib (Part C) Receives: Drug: CX-072; Drug: vemurafenib |
| CX-072 expansion | Experimental | Monotherapy CX-072 (Part D) Receives: Drug: CX-072 |
| CX-072 long-term extension | Experimental | Monotherapy CX-072 Receives: Drug: CX-072 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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.
- First posted6 Jan 2017 (estimated)
- Study start19 Jan 2017
- Primary completion27 Oct 2020
- Study completion27 Oct 2020
Why it stopped: Sponsor's decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- CytomX Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Monika Vainorius, M.D., Study director, CytomX Therapeutics
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
- Results posted
- Yes, on ClinicalTrials.gov
- 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 34301809Sanborn 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 34301808Giesen 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
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03013491
- Acronym / sponsor ID
- CTMX-M-072-001
- Conditions
- Solid Tumor, Lymphoma
- Keywords
- cancer, checkpoint inhibitor, monotherapy, combination, PD-L1, CTLA-4, solid tumor, lymphoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor's decision
- Enrolment
- 196 participants (actual)
- Lead sponsor
- CytomX TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 19 Jan 2017 (actual)
- Primary completion
- 27 Oct 2020 (actual)
- Study completion
- 27 Oct 2020 (actual)
- First posted
- 6 Jan 2017 (estimated)
- Results
- Posted 17 Jun 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| CX-072 #1 | Experimental | Drug: CX-072Monotherapy CX-072 (Part A) |
| CX-072 #2 | Experimental | Drug: CX-072Monotherapy CX-072 (Part A2) |
| CX-072 with Ipilimumab #1 | Experimental | Drug: CX-072, Drug: ipilimumabCombination CX-072 + ipilimumab (Part B1) |
| CX-072 with Ipilimumab #2 | Experimental | Drug: CX-072, Drug: ipilimumabCombination CX-072 + ipilimumab (Part B2) |
| CX-072 with Vemurafenib | Experimental | Drug: CX-072, Drug: vemurafenibCombination CX-072 + vemurafenib (Part C) |
| CX-072 expansion | Experimental | Drug: CX-072Monotherapy CX-072 (Part D) |
| CX-072 long-term extension | Experimental | Drug: CX-072Monotherapy CX-072 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CX-072Solution for infusion | Drug | CX-072 #1, CX-072 #2, CX-072 expansion, CX-072 long-term extension, CX-072 with Ipilimumab #1, CX-072 with Ipilimumab #2, CX-072 with Vemurafenib |
| ipilimumabSolution for infusion | Drug | CX-072 with Ipilimumab #1, CX-072 with Ipilimumab #2 |
| vemurafenibTablet | Drug | CX-072 with Vemurafenib |
Primary outcome
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
1 secondary outcome
The Percentage of Subjects Experiencing Anti-cancer Activity (ORR) When Given 10 mg/kg CX-072 as Monotherapy
Time frame: 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34301809Naing 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.
- Derived from this study: PubMed 34301808Sanborn 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.
- Derived from this study: PubMed 31953313Giesen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Monika Vainorius, M.D. study director
CytomX Therapeutics
31 sites in 6 countries: see every site and its status.
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.