Clear Cell Renal Cell CarcinomaPhase 1NCT05433142
Study of XmAb®819 in Subjects With Advanced Clear Cell Renal Cell Carcinoma
A Phase 1 study testing XmAb819 in people with Clear Cell Renal Cell Carcinoma, run by Xencor, Inc. at 26 sites in 5 countries.
Trial summary
The purpose of this study is to assess the safety and tolerability of XmAb®819 administered intravenous (IV) or subcutaneous (SC) in subjects with relapsed or refractory clear cell renal cell carcinoma and to identify the minimum safe and biologically active dose and the recommended dose (RD). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Clear Cell Renal Cell Carcinoma
- What is being tested?
- XmAb819
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 307 participants
- Where
- 26 sitesin 5 countries
- Study dates
- 13 Jun 2022to Dec 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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
- Subjects must have measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST 1.1) as assessed by the local site investigator. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
- Subjects who have relapsed and refractory ccRCC, pRCC, NSCLC, and CRC with evidence of disease progression on standard-of-care therapies
- ECOG performance status of 0 or 1.
- All subjects must have adequate tumor sample available (slides or archival FFPE blocks)
Who cannot join
- Prior treatment with an investigational anti-ENPP3/CD203c therapy
- History of serious allergic or anaphylactic/hypersensitivity reaction to monoclonal antibody therapy
- Systemic antineoplastic therapy within 5 half-lives on the first dose of study treatment.
- Failure to recover from any clinically significant toxicity related to previous anticancer treatment
- Have known active central nervous system metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are radiologically stable,
- Active known autoimmune disease (except that subjects are permitted to enroll if they have vitiligo; type 1 diabetes mellitus; residual hypothyroidism due to an autoimmune condition that is treatable with hormone replacement therapy only; psoriasis, atopic dermatitis, or another autoimmune skin condition that is managed without systemic therapy; or arthritis that is managed without systemic therapy beyond oral acetaminophen and nonsteroidal anti-inflammatory drugs)
- Evidence of any serious infection requiring IV anti-infective treatment within 14 days prior to the first dose of study drug
- Have a known additional malignancy that is progressing or has required active treatment within the past 2 years
Trial locations and contacts
26 sites in 5 countries. Contact the study team or a site near you to ask about taking part.
819-01 Study Information contact
26 sites in 5 countries
United States20 sites, 20 recruiting
- Recruiting
Xencor Investigative Site
Atlanta, Georgia, 30322
- Recruiting
Xencor Investigative Site
Charlotte, North Carolina, 28777
- Recruiting
Xencor Investigative Site
Chicago, Illinois, 60611
- Recruiting
Xencor Investigative Site
Chicago, Illinois, 60637
- Recruiting
Xencor Investigative Site
Cincinnati, Ohio, 45267
- Recruiting
Xencor Investigative Site
Columbus, Ohio, 43210
- Recruiting
Xencor Investigative Site
Duarte, California, 91010
- Recruiting
Xencor Investigative Site
Durham, North Carolina, 27710
- Recruiting
Xencor Investigative Site
Jacksonville, Florida, 32224
- Recruiting
Xencor Investigative Site
Louisville, Kentucky, 40207
- Recruiting
Xencor Investigative Site
Nashville, Tennessee, 37203
- Recruiting
Xencor Investigative Site
New Brunswick, New Jersey, 088901
- Recruiting
Xencor Investigative Site
New Haven, Connecticut, 06520
- Recruiting
Xencor Investigative Site
New York, New York, 10032
- Recruiting
Xencor Investigative Site
New York, New York, 10065
- Recruiting
Xencor Investigative Site
Oklahoma City, Oklahoma, 73104
- Recruiting
Xencor Investigative Site
Phoenix, Arizona, 85054
- Recruiting
Xencor Investigative Site
Rochester, Minnesota, 55905
- Recruiting
Xencor Investigative Site
Sacramento, California, 95817
- Recruiting
Xencor Investigative Site
Seattle, Washington, 98109
France2 sites, 2 recruiting
- Recruiting
Xencor Investigative Site
Bourdeaux, 33075
- Recruiting
Xencor Investigative Site
Villejuif, 94805
Spain2 sites, 2 recruiting
- Recruiting
Xencor Investigative Site
Barcelona, 08035
- Recruiting
Xencor Investigative Site
Madrid, 28050
United Kingdom1 site, 1 recruiting
- Recruiting
Xencor Investigative Site
Cambridge, Cambridgeshire, CB2 0QQ
About this study
Official title: A Phase 1 Multiple Dose Study to Evaluate the Safety and Tolerability of XmAb819 in Subjects With Relapsed or Refractory Clear Cell Renal Cell Carcinoma
The purpose of this study is to assess the safety and tolerability of XmAb®819 administered intravenous (IV) or subcutaneous (SC) in subjects with relapsed or refractory clear cell renal cell carcinoma and to identify the minimum safe and biologically active dose and the recommended dose (RD).
Read the detailed description
This is a Phase 1, multicenter, open-label, multiple-dose study designed in 2 parts: dose escalation, and dose expansion. The study is designed to establish the dosing schedule of XmAb819 administered IV and the dosing schedule of XmAb819 administered SC. The study is designed to evaluate safety and tolerability; to assess PK/PD and immunogenicity; and to preliminarily assess antitumor activity of XmAb819 in subjects with ccRCC and other solid tumors. All eligible subjects will have relapsed or refractory disease after standard therapy.
- Conditions
- Clear Cell Renal Cell Carcinoma
- Being tested
- XmAb819
- Keywords
- Clear cell Papillary, RCC, Renal Cell Cancer, Kidney Cancer, Lung Cancer, Colon Cancer
- Medical subject headings
- Carcinoma, Renal Cell, Kidney Neoplasms, Lung Neoplasms, Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XmAb819Biological
Monoclonal Bispecific Antibody
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation and Expansion | Experimental | Dose Escalation will establish the dosing schedule for XmAb819 administered IV and the dosing schedule of XmAb819 administered SC. The dosing schedule includes the priming dose, step-up priming dose(s), the minimum safe and biologically active dose.
Dose Expansion may administer XmAb819 IV, and XmAb819 SC. Receives: Biological: XmAb819 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment-emergent adverse events (safety and tolerability of XmAb819)
Safety and tolerability as assessed by incidence of TEAEs; incidence of clinically significant changes in safety laboratory tests, PE findings, vital signs, and ECGs; incidence and severity of CRS
Measured: 28 days
Incidence of dose limiting toxicities (DLTs)
Safety and tolerability as assessed by incidence of DLTs and all available data which will be used to determine the optimal dose regimen.
Measured: 28 days
Secondary outcomes (5)
Measurement of Cmax
Peak plasma concentration (Cmax)
Measured: 56 days
Measurement of AUCtau
Area under the plasma concentration versus time curve (AUCtau)
Measured: 56 days
Objective Response rate
Objective response rate (RECIST 1.1 assessment of CT/MRI imaging)
Measured: 42 days
Progression-free survival
Progression-free survival (RECIST 1.1 assessment of CT/MRI imaging)
Measured: 42 days
Duration of response
Duration of response (RECIST 1.1 assessment of CT/MRI imaging)
Measured: 42 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2022
- Study start13 Jun 2022
- Primary completionFeb 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clear Cell Renal Cell CarcinomaStudies 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 307 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xencor, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- 819-01 Study Information, Study director, Xencor, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05433142
- Sponsor's protocol ID
- XmAb819-01
- Status last verified
- Jun 2026
- First submitted
- 13 Jun 2022
- Last updated
- 3 Aug 2026
- Results posted
- No
- 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 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Multiple Dose Study to Evaluate the Safety and Tolerability of XmAb819 in Subjects With Relapsed or Refractory Clear Cell Renal Cell Carcinoma
- ClinicalTrials.gov ID
- NCT05433142
- Acronym / sponsor ID
- XmAb819-01
- Conditions
- Clear Cell Renal Cell Carcinoma
- Keywords
- Clear cell Papillary, RCC, Renal Cell Cancer, Kidney Cancer, Lung Cancer, Colon Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 307 participants (estimated)
- Lead sponsor
- Xencor, Inc.Industry (pharma, biotech, devices)
- Study start
- 13 Jun 2022 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 27 Jun 2022 (actual)
- Results
- Not posted in the source record
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 study is to assess the safety and tolerability of XmAb®819 administered intravenous (IV) or subcutaneous (SC) in subjects with relapsed or refractory clear cell renal cell carcinoma and to identify the minimum safe and biologically active dose and the recommended dose (RD).
Detailed description
This is a Phase 1, multicenter, open-label, multiple-dose study designed in 2 parts: dose escalation, and dose expansion. The study is designed to establish the dosing schedule of XmAb819 administered IV and the dosing schedule of XmAb819 administered SC. The study is designed to evaluate safety and tolerability; to assess PK/PD and immunogenicity; and to preliminarily assess antitumor activity of XmAb819 in subjects with ccRCC and other solid tumors. All eligible subjects will have relapsed or refractory disease after standard therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation and Expansion | Experimental | Biological: XmAb819Dose Escalation will establish the dosing schedule for XmAb819 administered IV and the dosing schedule of XmAb819 administered SC. The dosing schedule includes the priming dose, step-up priming dose(s), the minimum safe and biologically active dose. Dose Expansion may administer XmAb819 IV, and XmAb819 SC. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects must have measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST 1.1) as assessed by the local site investigator. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
- Subjects who have relapsed and refractory ccRCC, pRCC, NSCLC, and CRC with evidence of disease progression on standard-of-care therapies
- ECOG performance status of 0 or 1.
- All subjects must have adequate tumor sample available (slides or archival FFPE blocks)
Key exclusion criteria (8 listed)
- Prior treatment with an investigational anti-ENPP3/CD203c therapy
- History of serious allergic or anaphylactic/hypersensitivity reaction to monoclonal antibody therapy
- Systemic antineoplastic therapy within 5 half-lives on the first dose of study treatment.
- Failure to recover from any clinically significant toxicity related to previous anticancer treatment
- Have known active central nervous system metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are radiologically stable,
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 |
|---|---|---|
| XmAb819Monoclonal Bispecific Antibody | Biological | Dose Escalation and Expansion |
Primary outcome
Incidence of treatment-emergent adverse events (safety and tolerability of XmAb819)
Time frame: 28 days
Safety and tolerability as assessed by incidence of TEAEs; incidence of clinically significant changes in safety laboratory tests, PE findings, vital signs, and ECGs; incidence and severity of CRS
Incidence of dose limiting toxicities (DLTs)
Time frame: 28 days
Safety and tolerability as assessed by incidence of DLTs and all available data which will be used to determine the optimal dose regimen.
5 secondary outcomes
Measurement of Cmax
Time frame: 56 days
Measurement of AUCtau
Time frame: 56 days
Objective Response rate
Time frame: 42 days
Progression-free survival
Time frame: 42 days
Duration of response
Time frame: 42 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2026.
- 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.
819-01 Study Information contact
819-01 Study Information study director
Xencor, Inc.
26 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing XmAb819 in people with Clear Cell Renal Cell Carcinoma, run by Xencor, Inc. at 26 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 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: looking for participants now, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in United States, France, Spain, Belgium, United Kingdom. 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact 819-01 Study Information (819-01info@xencor.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of treatment-emergent adverse events (safety and tolerability of XmAb819) (time frame: 28 days). The study lists 2 primary outcomes in all. 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 3 Aug 2026.