Solid TumorPhase 2NCT03993379
PROCLAIM: CX-072-002: Study of PD-L1 Probody Therapeutic CX-072 in Combination With Other Anticancer Therapy in Adults With Solid Tumors
A Phase 2 study testing CX-072 and Ipilimumab in people with Solid Tumor and Unresectable or Metastatic Melanoma, run by CytomX Therapeutics at 27 sites in 5 countries.
Trial 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) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor, Unresectable or Metastatic Melanoma
- What is being tested?
- CX-072 and Ipilimumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 27 sitesin 5 countries
- Study dates
- 20 Nov 2019to 21 May 2020
- Phase
- Phase 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
- 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
Who cannot join
- 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
Trial locations and contacts
27 sites in 5 countries.
27 sites in 5 countries
United States14 sites
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
University of Chicago
Chicago, Illinois, 60637
Beacon Cancer Care
Coeur d'Alene, Idaho, 83814
City of Hope National Medical Center
Duarte, California, 91010
Inova Dwight and March Schar Cancer Institute
Fairfax, Virginia, 22031
Virginia Cancer Specialists
Fairfax, Virginia, 22031
The Angeles Clinic and Research Institute
Los Angeles, California, 90025
Norton Cancer Institute
Louisville, Kentucky, 40202
NYC Cancer Institute
New York, New York, 10016
Columbia Medical Center
New York, New York, 10032
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232
Oregon Health & Science Center
Portland, Oregon, 97210
Providence Portland Medical Center
Portland, Oregon, 97213
Multicare Institute for Research and Innovation
Spokane, Washington, 99204
Spain5 sites
ICO Hospitalet, Hospital Duran I Reynals
Barcelona, 08908
Hospital Clinic de Barcelona. Servicio Oncologia Medica
Barcelona
Hospital Universitario La Paz
Madrid
START- Madrid
Madrid
Clinica Universitaria de Navarra
Pamplona
South Korea4 sites
Asan Medical Center
Seoul
Samsung Medical Center
Seoul
Seoul National University Hospital
Seoul
Severance Hospital Yonsei University Health System
Seoul
Australia2 sites
Sunshine Coast University Private Hospital
Sunshine Coast, Queensland
Ballarat Oncology and Haematology Services
Wendouree, Victoria
Netherlands2 sites
The Netherlands Cancer Institute
Amsterdam
University Medical Center Groningen
Groningen
About this study
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
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)
- Conditions
- Solid Tumor, Unresectable or Metastatic Melanoma
- Being tested
- CX-072, Ipilimumab
- Keywords
- Combination, ipilimumab, Cancer, checkpoint inhibitor, PD-L1, CTLA-4, PROCLAIM, PROCLAIM-CX-072, Relapsed, Refractory
- Medical subject headings
- Melanoma, Neoplasms, Diabetes Mellitus, Insulin-Dependent, 12, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CX-072Drug
CX-072 in combination with ipilimumab
IpilimumabDrug
CX-072 in combination with ipilimumab
| Study group | Role | What they receive |
|---|---|---|
| CX-072 in combination with anti-cancer therapy-front line | Experimental | histologically or cytologically confirmed solid tumor who have received no prior treatment Receives: Drug: CX-072 |
| CX-072 in combination with ipilimumab | Experimental | 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 Receives: Drug: CX-072; Drug: Ipilimumab |
| CX-072 in combination with anti-cancer therapy-Progressed | Experimental | histologically or cytologically confirmed, advanced/unresectable or metastatic solid tumor that have experienced disease progression during or following treatment with platinum based therapy Receives: Drug: CX-072 |
| CX-072 in combination with anti-cancer therapy-Neoadjuvant | Experimental | neo-adjuvant study in subjects with histologically confirmed solid tumor Receives: Drug: CX-072 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate by RECIST v 1.1
ORR by RECIST v1.1
Measured: 1 year
Secondary outcomes (2)
The Percentage of Patients Experiencing Treatment Related Adverse Events
Safety and Tolerability of CX-072 in Combination Therapy
Measured: 2 years
The Numbers of Patients Experiencing Anti-tumor Activity by irRECIST
ORR by irRECIST
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 posted20 Jun 2019
- Study start20 Nov 2019
- Primary completion21 May 2020
- Study completion21 May 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.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- CytomX Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lawrence Lu, MD, Study director, CytomX Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03993379
- Sponsor's protocol ID
- CTMX-M-072-002
- Status last verified
- Dec 2025
- First submitted
- 14 May 2019
- Last updated
- 26 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03993379
- Acronym / sponsor ID
- CTMX-M-072-002
- Conditions
- Solid Tumor, Unresectable or Metastatic Melanoma
- Keywords
- Combination, ipilimumab, Cancer, checkpoint inhibitor, PD-L1, CTLA-4, PROCLAIM, PROCLAIM-CX-072
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor's Decision
- Enrolment
- 3 participants (actual)
- Lead sponsor
- CytomX TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 20 Nov 2019 (actual)
- Primary completion
- 21 May 2020 (actual)
- Study completion
- 21 May 2020 (actual)
- First posted
- 20 Jun 2019 (actual)
- Results
- Posted 1 Dec 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| CX-072 in combination with anti-cancer therapy-front line | Experimental | Drug: CX-072histologically or cytologically confirmed solid tumor who have received no prior treatment |
| CX-072 in combination with ipilimumab | Experimental | Drug: CX-072, Drug: Ipilimumabhistologically 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 |
| CX-072 in combination with anti-cancer therapy-Progressed | Experimental | Drug: CX-072histologically or cytologically confirmed, advanced/unresectable or metastatic solid tumor that have experienced disease progression during or following treatment with platinum based therapy |
| CX-072 in combination with anti-cancer therapy-Neoadjuvant | Experimental | Drug: CX-072neo-adjuvant study in subjects with histologically confirmed solid tumor |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
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-072CX-072 in combination with ipilimumab | Drug | CX-072 in combination with anti-cancer therapy-Neoadjuvant, CX-072 in combination with anti-cancer therapy-Progressed, CX-072 in combination with anti-cancer therapy-front line, CX-072 in combination with ipilimumab |
| IpilimumabCX-072 in combination with ipilimumab | Drug | CX-072 in combination with ipilimumab |
Primary outcome
Overall Response Rate by RECIST v 1.1
Time frame: 1 year
ORR by RECIST v1.1
2 secondary outcomes
The Percentage of Patients Experiencing Treatment Related Adverse Events
Time frame: 2 years
The Numbers of Patients Experiencing Anti-tumor Activity by irRECIST
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 26 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Lawrence Lu, MD study director
CytomX Therapeutics
27 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CX-072 and Ipilimumab in people with Solid Tumor and Unresectable or Metastatic Melanoma, run by CytomX Therapeutics at 27 sites in 5 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 4 inclusion and 7 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 26 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in United States, Spain, South Korea, Australia, Netherlands. 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 phase mean?
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 1 Dec 2021). 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?
Overall Response Rate by RECIST v 1.1 (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Dec 2025.