At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- XmAb819 (biological)
- How long the study runs
- Study runs about 78 months (dates as stated)
- About the drug or intervention
- XmAb819 — biological: Monoclonal Bispecific Antibody
- Patient visit burden
- Not specified by the sponsor
In plain English
This study is looking at a drug called XmAb®819 in people with advanced clear cell renal cell carcinoma, a type of kidney cancer. It is for people whose cancer has come back or not responded to standard treatments. The study is run by Xencor, Inc.
Who can take part
- Cancer that can be measured on scans
- Cancer that has come back or not responded to standard treatment (including clear cell kidney cancer, papillary kidney cancer, lung cancer, or bowel cancer, where disease has got worse on standard care)
- Fully active or able to carry out light activities (performance status of 0 or 1)
- A stored tumour sample available (for example, a tissue block or slides)
Who may not be able to
- Previous treatment with an experimental anti-ENPP3/CD203c therapy
- A serious allergic reaction to monoclonal antibody treatment in the past
- Cancer treatment within 5 half-lives before the first study dose
- Ongoing significant side effects from earlier cancer treatment
- Active cancer spread to the brain or the membranes around the brain (treated brain spread is allowed if stable on scans)
- Active autoimmune disease (some mild conditions are allowed, such as vitiligo, type 1 diabetes, or mild skin or joint conditions)
- A serious infection needing treatment into a vein within 14 days before the first dose
- Another cancer that is growing or needed treatment in the past 2 years
What taking part involves
- • Not stated — ask the trial team
Time commitment: Not stated — ask the trial team
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 307
- Started
- 2022-06-13
- Last checked
- 2026-06
Plain English Summary
What is this study?
- • Testing a new treatment for clear cell renal cell carcinoma
- • Phase1 - 307 participants
- • 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)
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with clear cell renal cell carcinoma
Where?
- • Cambridge - Xencor Investigative Site
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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).
More detail
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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
- How fit you need to be: ECOG 0 or better
Treatment history
Treatments you must have had:
- ✓ measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST 1
- ✓ adequate tumor sample available (slides or archival FFPE blocks)
What the study is looking for
- ✓Subjects who have relapsed and refractory ccRCC, pRCC, NSCLC, and CRC with evidence of disease progression on...
- ✓Fit enough for normal activity (ECOG 0) or 1.
- ✓All subjects must have adequate tumor sample available (slides or archival FFPE blocks)
Who cannot take part
- ✗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...
See the full criteria
Where Is This Study? (1 UK site)
Xencor Investigative Site
Cambridge CB2 0QQ, United Kingdom
How to Get in Touch
819-01 Study Information
Sponsor contactCONTACT