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A Phase 1b Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of ATP150/ATP152, VSV-GP154 and Ezabenlimab (BI 754091) in Patients With KRAS G12D/G12V Mutated Pancreatic Ductal Adenocarcinoma (KISIMA-02)
Cancer Categories
Gastrointestinal (GI)
Karmanos Trial ID
2023-022
NCT ID
NCT05846516
Age Group
Adult
Scope
National
Phase
Phase I
Includes initial studies to determine the metabolism and pharmacologic actions of drugs in humans, the side effects associated with increasing doses, and to gain early evidence of effectiveness; may include healthy participants and/or patients.
Phase I
Principal Investigator
Anthony
Shields, M.D., Ph.D.
Oncology - Medical
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Objective:
Primary Objectives:
Part A and Part B
To assess the safety and tolerability of the study treatment.
Part C
To assess efficacy in regards of disease-free survival of the study treatment.
Secondary Objectives:
Part C
To assess ctDNA clearance in ctDNA positive patients.
To assess ctDNA non-progression in ctDNA negative patients.
To assess the safety and tolerability of the study treatment.
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NCI Dictionary of Cancer Terms
KCI Clinical Trials App
Eligibility
Locations
Applicable Disease Site
Therapies | Drugs | Devices
Eligibility
Eligibility
Inclusion Criteria:
Histologically or cytologically confirmed pancreatic ductal adenocarcinoma (PDAC) with KRAS G12D or KRAS G12V mutation.
ECOG performance status of 0 or 1.
Patients with advanced or metastatic disease who completed at least 16 weeks of standard systemic chem-/chemoradiotherapy and achieved a partial response or stable disease.
Patients who underwent confirmed R0 or R1 resection and completed at least 3 months of combined peri-adjuvant multiagent chemotherapy.
No evidence of disease progression or recurrence.
Start of study treatment within 12 weeks from the last curative treatment (resected PDAC).
Life expectancy at least 12 months (resected PDAC), or at least 6 months (advanced/metastatic PDAC).
Archival tumor tissue availability for central KRAS analysis.
Exclusion Criteria:
Not yet recovered from surgery (resected PDAC).
Gastro-intestinal bowel obstruction.
Other malignancy within the last 3 years.
Prior chemotherapy or targeted small molecule therapy within 14 (locally advanced/metastatic PDAC) or 28 (resected PDAC) days from initiation of study treatment.
Prior radiotherapy within 14 (advanced/metastatic PDAC) or 28 (resected PDAC) days from initiation of study treatment.
Prior use of immunotherapeutic agents, including but not limited to checkpoint inhibitors or VSV-based agents.
Diagnosis of immunodeficiency.
Chronic systemic treatment with steroids or other immunosuppressive medications.
Active autoimmune disease requiring systemic treatment within the last 2 years.
Locations
Locations
Karmanos Cancer Institute - Detroit Headquarters
4100 John R
Detroit, MI 48201
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Phone:
800-527-6266
Karmanos Cancer Institute at Weisberg Cancer Center - Farmington Hills
31995 Northwestern Hwy
Farmington Hills, MI 48334
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Phone:
800-527-6266
Applicable Disease Site
Applicable Disease Site
Liver; Pancreas; Stomach
Therapies, Drugs, Devices
Therapies | Drugs | Devices
Therapies
Immunotherapy, Oncolytic Virus, Vaccine
Drugs
ATP150; ATP152; Ezabenlimab; VSV-GP154
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