Clinical trial · Interventional
A Study of CS1001 in Combination With Donafenib in Subjects With Advanced Solid Tumors
A Phase I, Multicenter,Open-label,Dose-Escalation and Expansion Study of CS1001 in Combination With Donafenib in Patients With Advanced Solid Tumors
NCT04472858CI-TRIAL-00062384unknownPhase 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 will evaluate the safety, tolerability, pharmacokinetics and treatment effect of CS1001 in combination with Donafenib 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 |
|---|---|---|---|
| Advanced Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CS1001 | Drug | Sugemalimab | ALIAS |
| Donafenib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Cholangiocarcinoma
- description
- Cholangiocarcinoma
- interventionNames
- Drug: Donafenib
- Drug: CS1001
- type
- EXPERIMENTAL
- label
- Squamous cell carcinoma of the head and neck
- description
- Squamous cell carcinoma of the head and neck（HNSCC）
- interventionNames
- Drug: Donafenib
- Drug: CS1001
- type
- EXPERIMENTAL
- label
- Endometrial cancer
- description
- Endometrial cancer
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Fully understand this study and voluntarily sign ICF; * 18 to 75 years old (including 18 and 75 years old), male or female; * Subjects with advanced solid tumors, including: Phase I study: subjects with advanced solid tumors confirmed by histology or cytology that are not suitable for surgical resection, or have failed or tolerated standard treatment, or have no standard treatment. Including but not limited to Cholangiocarcinoma , head and neck squamous cell carcinoma (HNSCC) and endometrial cancer. Exclusion Criteria: * Any history of active autoimmune diseases or autoimmune diseases; patients with vitiligo or asthma that has been completely relieved in childhood, and patients who do not need any intervention after adulthood can be included; * Participants with any condition that impairs their ability to take oral medication, such as lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome. * Patients with uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage and need to retain a catheter; * Human immunodeficiency virus (HIV) antibody positive; * Patients who are simultaneously infected with hepatitis B virus and hepatitis C virus; * Lactating women. If they are willing to stop breastfeeding, they can also be included in this study.
References
Publications (0)
Data not yet available
No reference posted for this study.