Clinical trial · Interventional
Study of AMV564 in Subjects With Advanced Solid Tumors
A Phase 1 Dose Escalation With Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of AMV564 Alone and in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors
NCT04128423CI-TRIAL-00054544unknownPhase 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)
This Phase 1 study is designed to assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of AMV564 alone and in combination with Pembrolizumab in patients with advanced solid tumors.
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 |
|---|---|---|---|
| Locally Advanced or Metastatic Solid Tumors | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AMV564 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- AMV564
- interventionNames
- Biological: AMV564
Primary outcomes (3)
- measure
- Incidence of Treatment-Related Adverse Events
- timeFrame
- Through study completion, an average of 19 months
- description
- As measured by the incidence, nature and severity of adverse events (AEs) and serious AEs
- measure
- Maximum tolerated dose of AMV564 in subjects with advanced solid tumors
- timeFrame
- During Dose Escalation, an average of 6 months
- description
- As determined based on the occurrence of dose-limiting toxicity
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Key Inclusion Criteria: * 18 years of age or older * Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 * Histologically or cytologically documented, incurable or metastatic solid tumor that is advanced (non-resectable) or recurrent and progressing since the last anti-tumor therapy and for which no recognized standard therapy exists * Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or per other criteria best suited for the specific tumor type being evaluated * Willing to complete all scheduled visits and assessments at the institution administering therapy Key Exclusion Criteria: * Treatment with any local or systemic antineoplastic therapy (including chemotherapy, hormonal therapy, or radiation) within 3 weeks prior to first dose of AMV564 * Major trauma or major surgery within 4 weeks prior to first dose of AMV564 * Prior treatment with chimeric antigen receptor (CAR) T-cell therapy or T-cell engager therapy * Chronic use of corticosteroids in excess of 10 mg daily of prednisone or equivalent within 4 weeks prior to first dose of AMV564 * Adverse events from prior anti-cancer therapy that have not resolved to Grade ≤ 1 except for alopecia * Known, central nervous system (CNS) disease involvement, or prior history of National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Grade ≥ 3 drug-related CNS toxicity
References
Publications (0)
Data not yet available
No reference posted for this study.