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
- Study HIC#:2000029250
- Last Updated:07/12/2021
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 an approved checkpoint inhibitor (CPI). Part 2 will be a cohort expansion into two solid tumor indications and one hematologic malignancy for ICT01 monotherapy, and one CPI-approved indication receiving ICT01 plus CPI.
- Start Date02/22/2021
- End Date12/01/2022
Trial Purpose and Description
Primary Outcome Measures :
- Adverse Events (Parts 1 & 2) [ Time Frame: 6 months ]Incidence of treatment-emergent adverse events
- Objective Response Rate using RECIST for solid tumor patients (Part 2) [ Time Frame: 6 months ]RECIST is measured every 8 weeks during treatment
- Objective Response Rate using RECIL for lymphoma patients (Part 2) [ Time Frame: 6 months ]RECIL is measured every 8 weeks during treatment
- Voluntarily signed informed consent form.
- 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)
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
- Life expectancy > 3 months as assessed by the Investigator
- At least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST)/ Response Evaluation Criteria in Lymphoma (RECIL) or >5% marrow blasts
- Any malignancy of Vγ9Vδ2 T cell origin
- 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)
- Treatment with investigational drug(s) within 28 days before study treatment
- 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.
- 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
- 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.
- Within 4 weeks of major surgery
- Documented history of active autoimmune disorders requiring systemic immunosuppressive therapy within the last 12 months
- Primary or secondary immune deficiency
- Active and uncontrolled infections requiring intravenous antibiotic or antiviral treatment