Clinical trial · Interventional
A Study of GFS101A in Combination With Toripalimab in Patients With Advanced Solid Tumors
A Multicenter, Open-label, Phase I/Ⅱ Study to Evaluate the Safety/Tolerability, Pharmacokinetics, and Efficacy of GFS101A in Combination With Toripalimab Treating Patients With Advanced Solid Tumors
NCT05165849CI-TRIAL-00058635withdrawnPhase 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
Why stopped (as posted): sponsor decided to withdraw the study
Summary
Brief summary (as posted)
The purpose of this study is to evaluate the safety/tolerability, pharmacokinetics, and efficacy of GFS101A in combination with Toripalimab 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 |
|---|---|---|---|
| Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| GFS101A | Drug | — | UNRESOLVED |
| Toripalimab | Drug | Toripalimab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- GFS101A+Toripalimab
- description
- Patient will be administrated with GFS101A IV in combination with Toripalimab IV. The duration of the treatment cycle is defined as 21 days.
- interventionNames
- Drug: GFS101A
- Drug: Toripalimab
Primary outcomes (2)
- measure
- Phase I：Incidence of dose limiting toxicity (DLT) events
- timeFrame
- 21days
- measure
- Phase II: Overall response rate (ORR) per RECIST 1.1
- timeFrame
- approximately 12 months after first dose
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Voluntarily participate in this clinical trial, and are willing to sign informed consent forms. 2. Male or female aged from 18-75 years old (inclusive). 3. Diagnosed with histologically or cytologically confirmed advanced solid tumors. 4. Evaluable lesions defined by RECIST v1.1. 5. Eastern Cooperative Oncology Group performance status of 0 to 1. 6. Subjects or their legal representatives are able to communicate well with Investigators and are willing to comply with the protocol and complete the study. Exclusion Criteria: 1. With clinically significant cardiac diseases 2. With clinically significant digestive disorders. 3. Other severe disease. 4. Pregnant or lactating women. 5. Other unfavorable situations for subjects to participate in the study judged by Investigators.
References
Publications (0)
Data not yet available
No reference posted for this study.