Clinical trial · Interventional
Study of XmAb®819 in Subjects With Advanced Clear Cell Renal Cell Carcinoma
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
NCT05433142CI-TRIAL-00120372recruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Clear Cell Renal Cell Carcinoma | Clear Cell Renal Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| XmAb819 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Dose Escalation and Expansion
- description
- 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.
- interventionNames
- Biological: XmAb819
Primary outcomes (2)
- measure
- Incidence of treatment-emergent adverse events (safety and tolerability of XmAb819)
- timeFrame
- 28 days
- description
- 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
- measure
- Incidence of dose limiting toxicities (DLTs)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.