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New treatment option for Clear Cell Renal Cell Carcinoma
Official title Study of XmAb®819 in Subjects With Advanced Clear Cell Renal Cell Carcinoma
ClinicalTrials.gov ID: NCT05433142
What this study is testing
What is XmAb819?
XmAb819 is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for clear cell renal cell carcinoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- people must have measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST 1.1) as assessed by the local site investigator. Lesions...
- people 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 people must have adequate tumor sample available (slides or archival FFPE blocks)
You likely can't join if
- 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. people with previously treated brain metastases may participate...
- Active known autoimmune disease (except that people are permitted to enroll if they have vitiligo; type 1 diabetes mellitus; residual hypothyroidism...
See the full eligibility criteria
- people 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...
- people 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 people must have adequate tumor sample available (slides or archival FFPE blocks)
- 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. people with previously treated brain metastases may participate provided they are radiologically stable,
- Active known autoimmune disease (except that people are permitted to enroll if they have vitiligo; type 1 diabetes mellitus; residual hypothyroidism due to an autoimmune condition that is treatable with hormone...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Phoenix, Arizona, United States
- Duarte, California, United States
- Sacramento, California, United States
- New Haven, Connecticut, United States
- Jacksonville, Florida, United States
- Atlanta, Georgia, United States
- Chicago, Illinois, United States
- Louisville, Kentucky, United States
- Rochester, Minnesota, United States
- New Brunswick, New Jersey, United States
- New York, New York, United States
- Charlotte, North Carolina, United States
- Durham, North Carolina, United States
- Cincinnati, Ohio, United States
- Columbus, Ohio, United States
- Oklahoma City, Oklahoma, United States
- Nashville, Tennessee, United States
- Seattle, Washington, United States
- Leuven, Belgium
- Bourdeaux, France
+ 4 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Phoenix, Arizona, United States; Duarte, California, United States; Sacramento, California, United States; New Haven, Connecticut, United States; Jacksonville, Florida, United States; Atlanta, Georgia, United States and 18 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.