Clinical trial · Interventional
A Study to Evaluate the Tolerability, Safety, and PK of AST-201 in Patients With GPC3-positive Advanced Solid Tumors
A Multi-center, Open-label, Dose Escalation and Expansion, Phase 1 Study to Evaluate the Tolerability, Safety and Pharmacokinetics of AST-201 in Patients With GPC3-positive Advanced Solid Tumors
NCT06687941CI-TRIAL-00106585recruitingPhase 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 is the first in human trial clinical study of AST-201 in patients with GPC3-positive advanced solid tumors. This study aims to evaluate the safety, tolerability, pharmacokinetic properties, and preliminary efficacy of AST-201 across various tumor types.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma, Hepatocellular | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Carcinoma, Non-Small-Cell Lung | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
| Liver Neoplasms | Liver Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Neoplasms | Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AST-201 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- AST-201
- description
- Participants receive AST-201 administered intravenously according to the study dosing schedule.
- interventionNames
- Drug: AST-201
Primary outcomes (1)
- measure
- Dose Limiting Toxicity (DLT)
- timeFrame
- 4 weeks
- description
- Dose-limiting toxicity (DLT) is defined as any treatment-related Grade 3 or higher adverse event, or other clinically significant toxicity occurring during the first cycle (4 weeks), that meets the protocol-defined criteria for dose limitation, based on the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version \[5.0\].
Secondary outcomes (11)
- measure
- Pharmacokinetics (PK): Cmax
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
Inclusion Criteria * Male and female aged ≥19 years * Histologically and/or cytologically diagnosed as the advanced recurrent solid tumor * GPC3-positive confirmed by IHC test * At least 1 measurable or non-measurable but evaluable lesion as defined per RECIST v1.1 (modified RECIST for hepatocellular carcinoma) * ECOG performance status of 0 or 1 * Life expectancy at least 12 weeks * Adequate hematologic, hepatic, renal, and heart/coagulation function * Child-Pugh Class of A for HCC Exclusion Criteria * Subjects with ischemic heart disease * Subjects with anti-tumor treatment within 4 weeks * Subjects with comorbidities such as uncontrolled hypertension, heart failure, etc. * Pregnant or potentially pregnant and lactating woman
References
Publications (0)
Data not yet available
No reference posted for this study.