NCT05020925UnknownPhase 1
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
Jiangsu HengRui Medicine Co., Ltd.1 site in 1 country30 target enrollmentStarted: September 2021Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- ORR
Study Overview
Brief Summary
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).
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
- •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.
Arms & Interventions
SHR-1701 plus Famitinib
Experimental
SHR-1701+Famitinib for R/M NPC failure after platinum-based chemotherapy and anti PD-1/PD-L1 antibody therapy
Intervention: SHR-1701 (Drug)
SHR-1701 plus Famitinib
Experimental
SHR-1701+Famitinib for R/M NPC failure after platinum-based chemotherapy and anti PD-1/PD-L1 antibody therapy
Intervention: Famitinib (Drug)
Outcomes
Primary Outcomes
ORR
Time Frame: up to approximately 2 years (anticipated)
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
- DoR(up to approximately 2 years (anticipated))
- DCR(up to approximately 2 years (anticipated))
- PFS(up to approximately 2 years (anticipated))
- OS(up to approximately 2 years (anticipated))
- AEs(up to approximately 2 years (anticipated))
Investigators
Study Sites (1)
Loading locations...
Similar Trials
Unknown
Phase 2
A Trial of SHR-1701 in Combination With and Without Famitinib Malate in Patients With Extensive Stage Small Cell Lung CancerLung CancerNCT04884009Jiangsu HengRui Medicine Co., Ltd.106
Active, not recruiting
Phase 2
A Trial of SHR-1701 With or Without Chemotherapy in Patients With Stage III NSCLCNon-Small-Cell Lung CancerNCT04580498Jiangsu HengRui Medicine Co., Ltd.107
Completed
Phase 1
A Safety and Efficacy Study of SHR-1702 Monotherapy in Patients With Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS)MDSAMLNCT04443751Jiangsu HengRui Medicine Co., Ltd.31
Completed
Phase 2
A Study of SHR-1210± SHR-1020 Versus Chemotherapy in Patients With Recurrent or Metastatic Cervical CancerRecurrent or Metastatic Cervical CancerNCT04680988Jiangsu HengRui Medicine Co., Ltd.194
Unknown
Phase 1
SHR-1701 in Metastatic or Locally Advanced Solid TumorsSolid TumorNCT03710265Jiangsu HengRui Medicine Co., Ltd.206