Clinical trial · Interventional
A Study Investigating AGEN1777 in Participants With Advanced Solid Tumors
A Phase 1 Study Investigating AGEN1777 as a Single-Agent and in Combination With a PD-1 Inhibitor in Patients With Advanced Solid Tumors
NCT05025085CI-TRIAL-00096599completedPhase 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 study is a multicenter, Phase 1 study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics of AGEN1777 as a single agent and when used in combination with a PD-1 inhibitor in participants with advanced, metastatic 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 |
|---|---|---|---|
| Advanced Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AGEN1777 | Drug | — | UNRESOLVED |
| a PD-1 inhibitor | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Monotherapy with AGEN1777
- description
- 3+3 Dose escalation of AGEN1777 will be administered by Intravenous (IV) infusion every 3 weeks (each cycle is 21 days \[3 weeks\]).
- interventionNames
- Drug: AGEN1777
- type
- EXPERIMENTAL
- label
- AGEN1777 in combination with a PD-1 inhibitor
- description
- 3+3 Dose escalation of AGEN1777 in combination with a PD-1 inhibitor will be administered by IV infusion with specified dose on specified days.
- interventionNames
- Drug: AGEN1777
- Drug: a PD-1 inhibitor
Primary outcomes (2)
- measure
- Number of Participants with Dose-Limiting Toxicities (DLT) of AGEN1777 as a Single-Agent and in Combination with a PD-1 inhibitor
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Key Inclusion Criteria: 1. Histologically or cytologically confirmed diagnosis of metastatic or locally advanced solid tumor for which no acceptable standard therapy available or progressed on or after standard therapies. 2. Measurable disease on baseline imaging based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1). 3. Life expectancy of at least 3 months and an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Key Exclusion Criteria: 1. Active infection requiring treatment. 2. Lack of recovery for participants who had major surgical procedure within 4 weeks prior to first dose of protocol therapy. 3. Clinically significant cardiovascular disease: cerebral vascular accident/stroke or myocardial infarction within 6 months of enrollment, unstable angina, congestive heart failure (New York Heart Association class ≥ II), or serious uncontrolled cardiac arrhythmia requiring medication. 4. Corrected QT interval (QTc) (corrected for heart rate using Fridericia's formula prolongation) \>480 msec at screening except for right bundle branch block.
References
Publications (0)
Data not yet available
No reference posted for this study.