Clinical trial · Interventional
Phase 1, First-in-human, Dose-finding and Expansion Study to Evaluate XmAb®808 in Combination With Pembrolizumab in Advanced Solid Tumors
A Phase 1, First-in-Human, Dose-Finding and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Activity of XmAb®808 in Combination With Pembrolizumab in Selected Advanced Solid Tumors
NCT05585034CI-TRIAL-00093220completedPhase 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 evaluate the safety, tolerability, and pharmacokinetics of intravenous (IV) administration of XmAb808 in combination with pembrolizumab in subjects with selected advanced solid tumors and to identify the minimum safe and biologically effective/recommended dose (RD) and schedule for XmAb808.
Conditions
Conditions (9)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Castration-resistant Prostate Cancer | Castration-Resistant Prostate Carcinoma | ALIAS | 0.90 |
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Head and Neck Squamous Cell Carcinoma | Head and Neck Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Melanoma Excluding Uveal Melanoma | — | UNRESOLVED | — |
| Non-small Cell Lung Cancer, Squamous or Non-squamous | Lung Non-Small Cell Carcinoma | ALIAS | 0.85 |
| Ovarian Cancer, Epithelial | Ovarian Carcinoma | ALIAS | 0.90 |
| Renal Cell Carcinoma, Clear Cell | Clear Cell Renal Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
| TNBC - Triple-Negative Breast Cancer | — | UNRESOLVED | — |
| Urothelial Carcinoma |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Keytruda® (pembrolizumab) | Biological | Pembrolizumab | ALIAS |
| XmAb®808 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Dose Escalation and Expansion XmAb®808 administered in combination with pembrolizumab
- description
- XmAb®808 in combination with pembrolizumab
- interventionNames
- Biological: XmAb®808
- Biological: Keytruda® (pembrolizumab)
Primary outcomes (2)
- measure
- Incidence of treatment-emergent adverse events (TEAEs)
- timeFrame
- Up to 5 years
- description
- Safety and tolerability as assessed by incidence of TEAEs, including clinically significant changes in safety laboratory tests and clinical findings
- measure
- Incidence of dose-limiting toxicities (DLTs)
- timeFrame
- 49 days
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Key Inclusion Criteria: * Part A: Histologically confirmed advanced/metastatic castration-resistant prostate adenocarcinoma, epithelial ovarian cancer, head and neck squamous cell carcinoma, non-small cell lung cancer, urothelial carcinoma, melanoma, renal cell carcinoma, triple-negative breast cancer, or colorectal cancer that has progressed on standard therapies * Part B: Histologically confirmed advanced/metastatic castration-resistant prostate cancer that is PD1-naïve; head and neck squamous cell carcinoma that is PD1-naïve or has progressed on prior PD1 therapy; or melanoma that is PD1-naïve or has progressed on prior PD1 therapy * Measurable disease by RECIST 1.1; subjects with prostate cancer who have evaluable disease according to PCWG3 criteria may enroll * Life expectancy \> 3 months * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 Key Exclusion Criteria: * Subjects currently receiving other anticancer therapies * Any prior treatment with an investigational agent targeting CD28 * History of a life-threatening adverse event related to prior immunotherapy * Known active central nervous system involvement by malignant disease. Subjects with previously treated brain metastases may participate provided they are radiologically and clinically stable
References
Publications (0)
Data not yet available
No reference posted for this study.