Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06626256
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-02
Brief Title:
STIL101 for Injection for the Treatment of Locally Advanced Metastatic or Unresectable Pancreatic Cancer Colorectal Cancer Renal Cell Cancer Cervical Cancer and Melanoma
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 1 Safety and Efficacy Study of STIL101 for Injection in Locally Advanced Unresectable or Metastatic Pancreatic Ductal Adenocarcinoma Colorectal Cancer Renal Cell Carcinoma Cervical Cancer and Melanoma
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase I trial tests the safety and side effects of STIL101 for injection and how well it works in treating patients with pancreatic cancer colorectal cancer CRC renal cell cancer RCC cervical cancer CC and melanoma that has spread to nearby tissue or lymph nodes locally advanced or to other places in the body metastatic or that cannot be removed by surgery unresectable STIL101 for injection an autologous made from the patients own cells cellular therapy is made up of specialized white blood cells called lymphocytes or T cells collected from a piece of the patients tumor tissue The T cells collected from the tumor are then grown in a laboratory to create STIL101 for injection STIL101 for injection is then given to the patient where it may attack the tumor Giving chemotherapy such as cyclophosphamide and fludarabine helps prepare the body to receive STIL101 for injection in a way that allows the T cells the best opportunity to attack the tumor Aldesleukin is a form of interleukin-2 a cytokine made by leukocytes Aldesleukin increases the activity and growth of white blood cells called T lymphocytes and B lymphocytes Giving STIL101 for injection may be safe tolerable andor effective in treating patients with locally advanced metastatic or unresectable pancreatic cancer CRC RCC CC and melanoma
Detailed Description:
PRIMARY OBJECTIVE
I Determine the safety of administering STIL101 for injection in subjects with locally advanced unresectable or metastatic pancreatic ducal adenocarcinoma PDAC CRC RCC CC or melanoma
SECONDARY OBJECTIVES
I Summarize the efficacy observed due to STIL101 for injection in patients with locally advanced unresectable or metastatic PDAC CRC RCC CC or melanoma
Ia Overall response rate ORR per Response Evaluation Criteria in Solid Tumors RECIST 11 and Immune-Modified iRECIST 10 Ib Disease control rate DCR as measured from STIL101 infusion Ic Overall survival OS as measured from STIL101 infusion Id Progression-free survival PFS as measured from STIL101 infusion II Summarize pre-STIL101 for injection therapy and outcomes from first study-related procedure
III Evaluate the feasibility and timing of generating STIL101 for injection IV Describe STIL101 cell count in patients with respect to baseline characteristics clinical outcome and adverse events
EXPLORATORY OBJECTIVE
I Biological correlatives associated with STIL101 for injection creation and infusion
OUTLINE
Patients undergo excisional biopsy and continue receiving standard of care therapy for 3-4 months prior to the start of study therapy Patients with successful generation of STIL101 for injection receive cyclophosphamide intravenously IV over 2 hours on days -5 to -4 fludarabine IV over 30 minutes on days -5 to -1 and STIL101 for injection IV on day 0 in the absence of disease progression or unacceptable toxicity Patients also receive aldesleukin subcutaneously SC once daily QD on day 0 for up to 6-10 days Additionally patients undergo blood sample collection biopsy computed tomography CT and optional magnetic resonance imaging MRI throughout the study
After completion of study treatment patients are followed up at days 42 56 70 and 84 then every 2-4 weeks up to week 96 or progression Patients who discontinued treatment are followed up every 6 months
I Determine the safety of administering STIL101 for injection in subjects with locally advanced unresectable or metastatic pancreatic ducal adenocarcinoma PDAC CRC RCC CC or melanoma
SECONDARY OBJECTIVES
I Summarize the efficacy observed due to STIL101 for injection in patients with locally advanced unresectable or metastatic PDAC CRC RCC CC or melanoma
Ia Overall response rate ORR per Response Evaluation Criteria in Solid Tumors RECIST 11 and Immune-Modified iRECIST 10 Ib Disease control rate DCR as measured from STIL101 infusion Ic Overall survival OS as measured from STIL101 infusion Id Progression-free survival PFS as measured from STIL101 infusion II Summarize pre-STIL101 for injection therapy and outcomes from first study-related procedure
III Evaluate the feasibility and timing of generating STIL101 for injection IV Describe STIL101 cell count in patients with respect to baseline characteristics clinical outcome and adverse events
EXPLORATORY OBJECTIVE
I Biological correlatives associated with STIL101 for injection creation and infusion
OUTLINE
Patients undergo excisional biopsy and continue receiving standard of care therapy for 3-4 months prior to the start of study therapy Patients with successful generation of STIL101 for injection receive cyclophosphamide intravenously IV over 2 hours on days -5 to -4 fludarabine IV over 30 minutes on days -5 to -1 and STIL101 for injection IV on day 0 in the absence of disease progression or unacceptable toxicity Patients also receive aldesleukin subcutaneously SC once daily QD on day 0 for up to 6-10 days Additionally patients undergo blood sample collection biopsy computed tomography CT and optional magnetic resonance imaging MRI throughout the study
After completion of study treatment patients are followed up at days 42 56 70 and 84 then every 2-4 weeks up to week 96 or progression Patients who discontinued treatment are followed up every 6 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None