NCT05433142 Study of XmAb®819 in Subjects With Advanced Clear Cell Renal Cell Carcinoma
| NCT ID | NCT05433142 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Xencor, Inc. |
| Condition | Clear Cell Renal Cell Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 307 participants |
| Start Date | 2022-06-13 |
| Primary Completion | 2027-02 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 307 participants in total. It began in 2022-06-13 with a primary completion date of 2027-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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).
Eligibility Criteria
Inclusion Criteria: * 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) Exclusion Criteria: * 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
Contact & Investigator
Chet Bohac, MD
✉ 819-01info@xencor.comChet Bohac, MD
STUDY DIRECTOR
Xencor, Inc.
Frequently Asked Questions
Who can join the NCT05433142 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Clear Cell Renal Cell Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05433142 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05433142 currently recruiting?
Yes, NCT05433142 is actively recruiting participants. Contact the research team at 819-01info@xencor.com for enrollment information.
Where is the NCT05433142 trial being conducted?
This trial is being conducted at Phoenix, United States, Duarte, United States, Sacramento, United States, New Haven, United States and 11 additional locations.
Who is sponsoring the NCT05433142 clinical trial?
NCT05433142 is sponsored by Xencor, Inc.. The principal investigator is Chet Bohac, MD at Xencor, Inc.. The trial plans to enroll 307 participants.