Clinical trial · Interventional
SHR-1701 in Patients With Recurrent/Metastatic Scchn
A Phase II,Open-label Trial to Investigate the Efficacy and Safety of SHR-1701 in Patients With Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck
NCT04650633CI-TRIAL-00054752unknownPhase 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, single-arm, multi-center, phase II study of SHR-1701 in patients with recurrent/metastatic SCCHN
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 |
|---|---|---|---|
| Squamous Cell Carcinoma of Head and Neck | Head and Neck Squamous Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SHR-1701 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- SHR-1701
- description
- R/M SCCHN subjects failure after 1 lines of platinum based chemotherapy or after anti PD-1/PD-L1 antibody therapy.
- interventionNames
- Drug: SHR-1701
Primary outcomes (1)
- measure
- Objective Response Rate (ORR) per RECIST 1.1
- timeFrame
- up to 2 years
- 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
Show eligibility criteria text
Inclusion Criteria: 1. Histologically confirmed Recurrent/Metastatic SCCHN,not include NPC 2. Subjects failure after 1 lines of platinum based chemotherapy or failure from anti-PD-1/PD-L1 antibody therapy. 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 at trial entry. 4. Disease must be measurable with at least 1 uni dimensional measurable lesion by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. 5. Adequate hematological, hepatic and renal function as defined in the protocol Other protocol-defined inclusion criteria could apply. Exclusion Criteria: 1. Prior therapy with an anti-PD1, anti-PD-L1, anti-CTLA-4 or a TGFb inhibitor. 2. Anticancer treatment within 28 days before the first dose of study drug. 3. Major surgery within 28 days before start of trial treatment. 4. 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. 5. With any active autoimmune disease or history of autoimmune disease. 6. 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.
References
Publications (0)
Data not yet available
No reference posted for this study.