Solid Tumor, Adult Clinical Trial
— EVICTIONOfficial title:
A First-in-human, Two-part Clinical Study to Assess the Safety, Tolerability and Activity of IV Doses of ICT01 as Monotherapy and in Combination With a Checkpoint Inhibitor, in Patients With Advanced-stage, Relapsed/Refractory Cancer
Part 1 will be a dose escalation study of IV ICT01 (a monoclonal antibody targeting BTN3A) as monotherapy in patients with advanced solid or hematologic tumors, followed by a cohort examining the combination of ICT01 plus pembrolizumab (Keytruda). Part 2 will be a cohort expansion into 2 solid tumor indications and one hematologic malignancy for ICT01 monotherapy, and 3 solid tumor indications for the combination of ICT01 plus pembrolizumab.
Status | Recruiting |
Enrollment | 150 |
Est. completion date | June 2024 |
Est. primary completion date | March 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Voluntarily signed informed consent form. 2. Relapsed/refractory patients with histologically or cytologically confirmed diagnosis of advanced-stage or recurrent cancer, including: Group A: bladder, breast, colon, gastric, melanoma, ovarian, prostate and PDAC Group B: hematologic malignancies including acute myeloid leukemia, acute lymphocytic leukemia, Diffuse large B cell lymphoma and follicular lymphoma Group C: melanoma, cervical, bladder, gastric, head and neck SCC, and lymphoma (according to the approved package labeling of the ICI) Part 2, Group D: Ovarian cancer (2L/3L) with baseline g9d2 T cells > 20K Part 2, Group E: metastatic castrate resistant prostate cancer (2L/3L) with baseline g9d2 T cells > 20K Part 2, Group F: newly diagnosed AML starting venetoclax/azacitidine Part 2, Group G: checkpoint-refractory metastatic melanoma with g9d2 T cells >5K Part 2, Group H: chemotx-refractory or Pt-ineligible urotherlial cancer (bladder) with g9d2 T cells >5K Part 2, Group I: checkpoint-refractory, metastatic HNSCC with g9d2 T cells >5K 3. Eastern Cooperative Oncology Group (ECOG) performance status = 1 4. Life expectancy > 3 months as assessed by the Investigator 5. At least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST)/ Response Evaluation Criteria in Lymphoma (RECIL) or >5% marrow blasts Exclusion Criteria: 1. Any malignancy of V?9Vd2 T cell origin 2. Any anti-tumor-directed drug therapy within 28 days or 5 times the elimination half-life (whichever is shorter) before study treatment (does not apply to patients receiving ICI for the combination arm) 3. Treatment with investigational drug(s) within 28 days before study treatment 4. Systemic steroids at a daily dose of > 10 mg of prednisone, > 2 mg of dexamethasone or equivalent, for the last 28 days and need for ongoing treatment. 5. Patients with rapidly progressing disease defined as advanced/metastatic, symptomatic, visceral spread, with a risk of life-threatening complications in the short term (e.g., during Screening Period/ treatment washout) that includes patients with massive uncontrolled effusions pleural, pericardial, peritoneal, pulmonary lymphangitis, and over 50% liver involvement 6. Ongoing immune-related adverse events (irAEs) and/or AEs =grade 2 not resolved from previous therapies except vitiligo, stable neuropathy up to grade 2, hair loss, and stable endocrinopathies with replacement hormone therapy. 7. Within 4 weeks of major surgery 8. Documented history of active autoimmune disorders requiring systemic immunosuppressive therapy within the last 12 months 9. Primary or secondary immune deficiency 10. Active and uncontrolled infections requiring intravenous antibiotic or antiviral treatment |
Country | Name | City | State |
---|---|---|---|
Belgium | Institut Jules Bordet | Brussels | |
France | Institut Paoli-Calmettes | Marseille | |
France | Gustave Roussy | Paris | |
Germany | University Carl Gustav Carus Clinical Trial Unit | Dresden | |
Spain | Vall d'Hebron Instiute of Oncology | Barcelona | |
United Kingdom | Institute of Cancer Research | London | |
United States | The University of Texas MD Anderson Cancer Center | Houston | Texas |
United States | Yale Cancer Center | New Haven | Connecticut |
United States | University of Washington | Seattle | Washington |
Lead Sponsor | Collaborator |
---|---|
ImCheck Therapeutics |
United States, Belgium, France, Germany, Spain, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Adverse Events (Parts 1 & 2) | Incidence of treatment-emergent adverse events | 12 months | |
Primary | Disease Control Rate using RECIST for solid tumor patients (Part 2) | RECIST is measured every 8 weeks during treatment | 12 months | |
Primary | Disease Control Rate using RECIL for lymphoma patients (Part 2) | RECIL is measured every 8 weeks during treatment | 12 months | |
Secondary | Change from Baseline in the Number of Circulating Gamma Delta T Cells | Flow cytometric counting of circulating gamma delta T cells | 28 days | |
Secondary | Change from Baseline in the Activation State of Circulating Gamma Delta T Cells | Flow cytometric measurement of CD69 and Ki67 expression on gamma delta T cells | 28 days | |
Secondary | Cmax following the first dose of ICT01 | PK parameter from serum ICT01 levels | 1 day | |
Secondary | AUC following the first dose of ICT01 | PK parameter from serum ICT01 levels | 21 days | |
Secondary | Clearance at steady-state of ICT01 | PK parameter from serum ICT01 levels | 6 months | |
Secondary | Half-life of ICT01 | PK parameter from serum ICT01 levels | 6 months | |
Secondary | Objective Response Rate using RECIST for solid tumor patients (Part 2) | RECIST is measured every 8 weeks during treatment | 12 months |
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