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Clinical Trial 21180

Cancer Type: Multiple
Study Type: Treatment
NCT#: NCT04243499

Phase: Phase I/II
Principal Investigator: Soliman, Hatem

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Overview

Study Title

A First-in-Human, Two-Part, Open-Label, Clinical Study to Assess the Safety, Tolerability and Activity of Intravenous Doses of ICT01 as Monotherapy and in Combination with an Immune Checkpoint Inhibitor, in Patients with Advanced-Stage, Relapsed/Refractory Cancer (EVICTION Study)

Summary

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 2-3 solid tumor indications and one hematologic malignancy for ICT01 monotherapy, and 1-2 solid tumor indication receiving ICT01 plus pembrolizumab.

Objective

Primary Part 1: Characterize the overall safety and tolerability profile of a range of IV doses of ICT01 as monotherapy, and in combination with pembrolizumab, in patients with advanced-stage, relapsed/refractory solid tumors or hematologic cancers. Part 2: Characterize the preliminary anti-tumor activity of IV ICT01 as monotherapy and in combination with pembrolizumab in patients with advanced-stage, relapsed/refractory solid tumors or hematologic cancers. Secondary Part 1: - Characterize the PK and PD of IV ICT01 administered to patients with advancedstage, relapsed/refractory solid tumors or hematologic cancers. - Characterize the preliminary anti-tumor activity of a range of IV doses of ICT01 as monotherapy and in combination with pembrolizumab when administered to patients with advanced-stage, relapsed/refractory solid tumors or hematologic cancers. - Determine the recommended dose(s) for the expansion cohorts (Part 2) for ICT01 as monotherapy and in combination with pembrolizumab. Part 2: - in combination with pembrolizumab in patients with advanced-stage, relapsed/refractory solid tumors or hematologic cancers. - Characterize the preliminary anti-tumor activity of IV ICT01 as monotherapy and in combination with pembrolizumab in patients with advanced-stage, relapsed/refractory solid tumors or hematologic cancers. - Characterize the PK and PD of IV ICT01 administered to patients with advancedstage, relapsed/refractory solid tumors or hematologic cancers.

Treatments

Therapies

Immunotherapy

Medications

ICT01 (); Not Applicable (); Pembrolizumab (Keytruda)

Inclusion Criteria

  • 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) Part 2, Group D: persistent or recurrent epithelial ovarian cancer, primary fallopian or primary peritoneal cancer; failed at least 1 prior systemic platinum-containing regimen. Group E: mCRPC patients who failed prior androgen deprivation therapy. Patients may have also failed prior taxane therapy Group G: metastatic or unresectable melanoma refractory to prior CPI treatment. Group H: locally advanced or metastatic urothelial carcinoma who are not eligible for any platinum-containing chemotherapy, or who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. Group I: metastatic or unresectable, recurrent HNSCC failed at least 1 prior systemic regimen
  • Willing to undergo baseline and on-study tumor biopsies
  • Eastern Cooperative Oncology Group (ECOG) performance status greater than or equal to 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
  • Additional criteria apply

  • Exclusion Criteria

  • 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 or 5 times the elimination half life (whichever is shorter) before study treatment. (Does not apply to patients receiving pembrolizumab for the combination arms)
  • 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

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