Clinical trial · Interventional
SHR-1701 in Combination With Famitinib in Patients With Recurrent/Metastatic Nasopharyngeal Carcinoma
A Phase I/II, Open-label, Multi-center Trial to Investigate the Efficacy and Safety of SHR-1701 in Combination With Famitinib in Patients With Recurrent/Metastatic Nasopharyngeal Carcinoma
NCT05020925CI-TRIAL-00053501unknownPhase 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 an open label, multi-center, phase I/II study to evaluate the efficacy and safety of SHR-1701 in combination with famitinib in subjects with recurrent/metastatic nasopharyngeal carcinoma(R/M NPC).
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 |
|---|---|---|---|
| Nasopharyngeal Carcinoma | Nasopharyngeal Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Famitinib | Drug | — | UNRESOLVED |
| SHR-1701 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- SHR-1701 plus Famitinib
- description
- SHR-1701+Famitinib for R/M NPC failure after platinum-based chemotherapy and anti PD-1/PD-L1 antibody therapy
- interventionNames
- Drug: SHR-1701
- Drug: Famitinib
Primary outcomes (1)
- measure
- ORR
- timeFrame
- up to approximately 2 years (anticipated)
- description
- ORR is defined as the percentage of participants in the analysis population who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: at least 30% decrease in the sum of diameters of target lesions) per RECIST 1.1.
Secondary outcomes (5)
- measure
- DoR
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed Recurrent/Metastatic Nasopharyngeal Carcinoma * Subjects failure after platinum-based chemotherapy and anti-PD-1/PD-L1 antibody therapy; * Able and willing to provide signed informed consent form, and able to comply with all procedures. * Life expectancy \>= 12 weeks as judged by the Investigator. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 at trial entry. * Disease must be measurable with at least 1 uni dimensional measurable lesion by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. * Adequate hematological, hepatic and renal function as defined in the protocol Other protocol-defined inclusion criteria could apply Exclusion Criteria: * Anticancer treatment within 28 days before the first dose of study drug. * Major surgery within 28 days before start of trial treatment. * Systemic therapy with immunosuppressive agents within 7 days prior to the first dose of study drug; or use any investigational drug within 28 days before the start of trial treatment. * With any active autoimmune disease or history of autoimmune disease. * With active central nervous system (CNS) metastases causing clinical symptoms or requiring therapeutic intervention. * History of immunodeficiency including seropositive for human immunodeficiency virus (HIV), or other acquired or congenital immunedeficient disease, or any active systemic viral infection requiring therapy. * Previous malignant disease (other than the target malignancy to be investigated in the trial) within the last 2 years. Subjects with history of cervical carcinoma in situ, superficial or non-invasive bladder cancer or basal cell or squamous cell cancer in situ previously treated with curative intent are NOT excluded.
References
Publications (0)
Data not yet available
No reference posted for this study.