Metastatic Neoplasm Clinical Trial
Official title:
A Phase 1 First-in-Human Dose Escalation and Expansion Study for the Evaluation of Safety, Pharmacokinetics, Pharmacodynamics and Anti-tumor Activity of SAR441000 Administered Intratumorally as Monotherapy and in Combination With Cemiplimab in Patients With Advanced Solid Tumors
Primary Objectives: - Dose Escalation: To determine maximum tolerated dose (MTD) or maximum administered dose (MAD) and overall safety and tolerability profile of SAR441000 when administered intratumorally as monotherapy and in combination with cemiplimab in patients who have no alternative standard treatment options. - Dose Expansion (Combination): To determine the objective response rate of SAR441000 administered intratumorally in combination with cemiplimab in patients with melanoma, cutaneous squamous cell carcinoma or head and neck squamous cell carcinoma. Secondary Objectives: - To characterize the pharmacokinetic (PK) profile of SAR441000 administered as monotherapy and in combination with cemiplimab. - To assess the immunogenicity of SAR441000. - To characterize the safety of SAR441000 when administered intratumorally in combination with cemiplimab. - To determine the disease control rate (DCR), duration of response (DoR) and progression free survival (PFS) of SAR441000. - To determine the recommended dose of SAR441000 for the expansion phase.
The expected duration of treatment for patients who benefit from study intervention may vary, based on progression date. Median expected duration of study per patient is estimated as 9 months in monotherapy and 12 months in combination therapy. The maximum treatment duration for non-progressive patients is up to 2 years. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Not yet recruiting |
NCT02226289 -
Bevacizumab-containing Regimen for Metastatic Colorectal Cancer Failed to Cytotoxic Treatment
|
Phase 2 | |
| Terminated |
NCT02566421 -
Genomic Sequencing in Determining Treatment in Patients With Metastatic Cancer or Cancer That Cannot Be Removed by Surgery
|
N/A | |
| Completed |
NCT01606033 -
Study of Stress and Life Quality of Patients Participating in Clinical Trials Versus Patients Non Participating
|
N/A | |
| Terminated |
NCT04418661 -
Safety and Efficacy Study of SAR442720 in Combination With Other Agents in Advanced Malignancies
|
Phase 1/Phase 2 | |
| Completed |
NCT00525057 -
Dalteparin in Preventing DVT in Participants With Cancer
|
N/A | |
| Completed |
NCT02775292 -
Gene-Modified T Cells, Vaccine Therapy, and Nivolumab in Treating Patients With Stage IV or Locally Advanced Solid Tumors Expressing NY-ESO-1
|
Phase 1 | |
| Recruiting |
NCT05617716 -
Spine Radiosurgery for Symptomatic Metastatic Neoplasms
|
Phase 2 | |
| Active, not recruiting |
NCT05103358 -
Phase 2 Basket Trial of Nab-sirolimus in Patients With Malignant Solid Tumors With Pathogenic Alterations in TSC1/TSC2 Genes (PRECISION 1)
|
Phase 2 | |
| Recruiting |
NCT02560311 -
Long-term Outcome of HER2-amplified Metastatic Breast Cancer: A Retrospective Analysis
|
N/A | |
| Completed |
NCT02492711 -
Margetuximab Plus Chemotherapy vs Trastuzumab Plus Chemotherapy in the Treatment of HER2+ Metastatic Breast Cancer
|
Phase 3 |