Clinical trial · Interventional
Study of IBI318 in Patients With Advanced Cutaneous Squamous Cell Carcinoma
A Phase Ib/II, Open-Label, Single Arm Study to Evaluate the Safety and Efficacy of IBI318 in Participants With Advanced Cutaneous Squamous Cell Carcinoma.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Due to the company's development strategy adjustment, Innovent Biologics has decided not to continue this study after consultation with investigators.
Summary
Brief summary (as posted)
The purpose of this study is to evaluate the safety and efficacy of IBI318 (anti-PD-1/PD-L1) in adult participants with metastatic (nodal or distant) cutaneous squamous cell carcinoma (CSCC), or unresectable locally advanced CSCC that is not amenable to surgery and/or radiation.
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 Cutaneous Squamous Cell Carcinoma | Skin Squamous Cell Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| IBI318 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Phase Ib/II
- description
- Patients with advanced CSCC. IBI318 administered intravenously every 2 weeks.
- interventionNames
- Drug: IBI318
Primary outcomes (1)
- measure
- Overall Response Rate ( evaluated by the independent review committee according to RECIST V1.1; 0-100%). Higher scores mean a better outcome
- timeFrame
- 24 months
- description
- RECIST version 1.1 will be used to determine ORR by IRRC
Secondary outcomes (5)
- measure
- Investigator Assessments of Overall Response Rate
- timeFrame
- 24 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Able to understand and willing to sign the ICF. 2. Adults 18 years of age or older. 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 4. Life expectancy at least 12 weeks. 5. Adequate organ and bone marrow function. 6. Histologically confirmed diagnosis of invasive CSCC. . Exclusion Criteria: 1. Prior treatment with an agent that blocks the PD-1/PD-L1 pathway. 2. Any investigational drugs received within 4 weeks prior to the first study treatment. 3. Receive the last dose of anti-tumor therapy within 4 weeks before the first dose of study therapy. 4. History of autoimmune disease , present active autoimmune disease or inflammatory diseases 5. Pregnant or nursing females.
References
Publications (0)
Data not yet available