Clinical Trial 21180

• 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; Therapy (NOS)

  Medications:

  GDC-0199 (Venetoclax); ICT01 (); Not Applicable (); Pembrolizumab (Keytruda); Venetoclax (); azacitidine (5-azacitidine)

• 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 > At least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST)/ Response Evaluation Criteria in Lymphoma (RECIL) or >5% marrow blasts
  • atients must have no available standard of care or treatment with potential survival benefit for their disease, as determined by the treating Investigator. Patients with mCRPC who have a BRCA1 or BRCA2 alterations mutation should have received other prior therapies including PARP inhibitors prior to enrollment in the study unless deemed inappropriate by the treating investigator. Melanoma patients who have BRAF V600E or V600K mutations must have received prior combination BRAF and MEK inhibitor therapy unless they have contraindications as determined by the treating investigator to be eligible for the trial.
  • 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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