Clinical trial · Interventional
A Study of ZW251 in Participants With Advanced Solid Tumors
A First-In-Human, Phase 1, Open-Label, Multicenter Study of ZW251, a Novel Glypican-3 Targeting Antibody-Drug Conjugate, in Participants With Advanced Solid Tumors, Including Hepatocellular Carcinoma
NCT07164313CI-TRIAL-00110697recruitingPhase 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 find out if ZW251, an antibody-drug conjugate targeting glypican-3 (GPC3), is safe and can treat participants with advanced cancers, including hepatocellular carcinoma (HCC), squamous cell non-small cell lung cancer (NSCLC), or germ cell tumors (GCT).
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Germ Cell Tumor | Germ Cell Tumor | ONTOLOGY_EXACT | 0.90 |
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Squamous Cell Non-Small Cell Lung Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ZW251 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- ZW251
- interventionNames
- Drug: ZW251
Primary outcomes (4)
- measure
- Incidence of dose-limiting toxicities (DLTs; Part 1)
- timeFrame
- Up to 3 weeks
- description
- Number of participants who experienced a DLT. DLTs include specifically defined adverse events (AEs) considered to be related to ZW251
- measure
- Incidence of AEs (Parts 1 and 2)
- timeFrame
- Up to approximately 2 years
- description
- Number of participants who experienced AEs, adverse events of special interest, or serious adverse events
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Pathologically or cytologically confirmed diagnosis of HCC with evidence of locally advanced (unresectable, and ineligible for transplant) and/or metastatic disease. Noninvasive methods may be used to confirm diagnosis * Pathologically or cytologically confirmed diagnosis of squamous cell NSCLC with evidence of locally advanced (unresectable) and/or metastatic disease * Pathologically or cytologically confirmed diagnosis of GCT with evidence of yolk sac and/or choriocarcinoma predominant component and locally advanced (unresectable) and/or metastatic disease * Measurable disease per RECIST v1.1 * Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1 * Liver function status of Child-Pugh Class A (for HCC only) * Adequate organ function Exclusion Criteria: * Known additional malignancy that is progressing or that has required active treatment within the last year * History of hepatic encephalopathy within the past 6 months or requirement for medications to control encephalopathy * Participants with HCC experiencing main portal vein tumor invasion require sponsor approval for enrollment * Known gastrointestinal bleeding within 3 months * Acute or chronic uncontrolled renal disease, pancreatitis, or non-malignant liver disease
References
Publications (0)
Data not yet available
No reference posted for this study.