Clinical trial · Interventional
Phase 1, Safety and Tolerability Study of XmAb541 in Advanced Solid Tumors
A Phase 1, First-in-Human, Dose Escalation and Expansion Study to Evaluate the Safety and Tolerability of XmAb541 in Advanced Solid Tumors
NCT06276491CI-TRIAL-00123637recruitingPhase 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 primary purpose of this study is to determine whether the investigational drug XmAb541 is safe and well tolerated, and to determine an optimal and safe dose(s) for further study. The study will also evaluate the effect of XmAb541 on tumor outcomes.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Endometrial Cancer | Malignant Endometrial Neoplasm | CURATED_BROADER | 0.80 |
| Germ Cell Tumor | Germ Cell Tumor | ONTOLOGY_EXACT | 0.90 |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
| Ovarian Germ Cell Tumor | Ovarian Germ Cell Tumor | ONTOLOGY_EXACT | 0.90 |
| Testicular Germ Cell Tumor | Testicular Germ Cell Tumor | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| XmAb541 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Dose escalation and Dose Expansion of XmAb541
- description
- Intravenous or Subcutaneous administration
- interventionNames
- Biological: XmAb541
Primary outcomes (3)
- measure
- Incidence of adverse events
- timeFrame
- Day 1 to 2 years
- measure
- Incidence of dose-limiting toxicities (DLTs)
- timeFrame
- Day 1 to Day 28
- measure
- Incidence of cytokine release syndrome (CRS)
- timeFrame
- Day 1 to Day 28
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 15 Years
Show eligibility criteria text
Key Inclusion Criteria: * Age ≥ 18 years. For US only: subjects with GCTs, age ≥15 years * CLDN6+ tumor * Histological or cytological documentation of locally advanced, recurrent, or metastatic ovarian, fallopian tube, or peritoneal cancer, adenocarcinoma of the endometrium (endometrial cancer, uterine cancer, or carcinoma of the uterine corpus), GCT resistant to previous treatment * Adequate Eastern Cooperative Oncology Group performance status * Life expectancy ≥ 3 months * Adequate liver, kidney, and bone marrow function Key Exclusion Criteria: * Participants with untreated brain metastases are excluded. Participants with treated brain metastases may participate, provided they are radiologically stable. * Active known or suspected autoimmune disease * Have any condition requiring systemic treatment with corticosteroids, prednisone equivalents, or other immunosuppressive medications within 14 days prior to first dose of study drug * Clinically significant cardiovascular, pulmonary or gastrointestinal disease * Active hepatitis B or hepatitis C
References
Publications (0)
Data not yet available
No reference posted for this study.