Clinical trial · Interventional
A Study of ZG005 Combined With Donafenib in Patients With Advanced Solid Tumor
A Multi-center, Open, Dose Exploration and Dose Expansion Phase I/II Study of ZG005 Combined With Donafenib Tosilate Tablets in Patients With Advanced Solid Tumor
NCT06239298CI-TRIAL-00077968unknownPhase 1 / Phase 2ClinicalTrials.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 a Multi-center, Open-labe, Phase I/II Study to evaluate the safety and tolerability of ZG005 Combined With Donafenib in Patients With Advanced Solid Tumor.
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 |
|---|---|---|---|
| Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Donafenib Tosilate Tablets | Drug | — | UNRESOLVED |
| ZG005 Powder for Injection | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Dose Exploration
- description
- The first stage is a dose-exploration study of ZG005 combined with Donafenib to evaluate the safety and tolerability of different dose combinations in patients with advanced solid tumors who have failed standard therapy.
- interventionNames
- Drug: ZG005 Powder for Injection
- Drug: Donafenib Tosilate Tablets
- type
- EXPERIMENTAL
- label
- Dose Expansion
- description
- The second stage is a dose-expansion study to further evaluate the safety and initial efficacy of the combination regimen in hepatocellular carcinoma, intrahepatic cholangiocarcinoma, and other potentially beneficial solid tumors.
- interventionNames
- Drug: ZG005 Powder for Injection
- Drug: Donafenib Tosilate Tablets
Primary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Fully understand the study and voluntarily sign the informed consent form. * Male or female 18-70 years of age; * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or * Life expectancy ≥ 3 months. Exclusion Criteria: * Patients were deemed unsuitable for participating in the study by the investigator for any reasons.
References
Publications (0)
Data not yet available
No reference posted for this study.