Clinical Trial 24136

• Overview

  Study Title:

  A Phase I/II Open-Label, Dose Escalation, Dose Optimization, and Cohort Expansion Trial to Investigate the Safety, Pharmacokinetics and Pharmacodynamics of UI-102, a Novel Cholesteryl Pullulan (CHP) Nanoparticle-formulated TLR7/8 Agonist in Patients with Selected Locally Advanced and/or Metastatic Solid Tumors

  Summary:

  This phase 1/2 first-in-human study is designed to assess the safety and efficacy of UI-102, a TLR7/8 agonist encapsulated in a Cholesteryl Pullulan Nanoparticle.

  Objective:

  Phase 1 Primary Objective: * To assess the safety and tolerability and determine the MTD (Dose Escalation) of UI-102 alone and the SRD (Cohort Expansion) of UI-102 alone Secondary Objectives: * To characterize the serum PK of UI-102 * To characterize the immunogenic potential of UI-102 and assess the relationship with PK * To evaluate anti-tumor response and durability of response as UI-102 monotherapy in selected solid tumors * To assess clinical efficacy outcomes, including progression-free survival (PFS), 3-month and 6-month landmark PFS, and overall survival * To assess AFP and anti-tumor response in participants with HCC. * To assess CEA and anti-tumor response in participants with G/GEJ adenocarcinoma and cholangioadenocarcinoma Phase 2: Primary Objectives: * To assess the safety and tolerability of UI-102 in combination with atezolizumab plus bevacizumab or biosimilar * To evaluate anti-tumor response and to establish the RP2D of UI-102 in combination with atezolizumab plus bevacizumab in HCC Secondary Objectives: * To characterize the serum pharmacokinetics (PK) of UI-102 * To characterize the immunogenic potential of UI-102 and assess the relationship with PK * To assess the durability of response * To assess AFP changes in participants with HCC * To assess clinical efficacy outcomes, including progression-free survival (PFS), 3- month and 6-month landmark PFS, and overall survival

• Treatments

  Therapies:

  Immunotherapy; Toll-like receptor (TLR) 7/8 agonist

  Medications:

  Atezolizumab (Tecentriq); Avastin (Bevacizumab); Bevacizumab (); UI-102 ()

• Inclusion Criteria

  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1,
  • 18 Years and Older (adult, older adult),
  • Histologically confirmed advanced cancer,
  • Archived or fresh tumor tissue sample that must be confirmed as adequate,
  • Evaluable/Measurable disease per RECIST 1.1,
  • Previously received applicable standard treatments,
  • Male and female participants of childbearing potential who are sexually active with a non-sterilized partner must agree to use highly effective methods of birth control

• Exclusion Criteria

  • Central nervous system metastasis,
  • Ongoing or uncontrolled ascites or pleural effusion,
  • Significant ongoing toxicity from prior anticancer treatment,
  • Out-of-range laboratory values,
  • Clinically significant lung, heart, or autoimmune disease,
  • Ongoing requirement for immunosuppressive treatment,
  • Significant secondary malignancy,
  • Hypersensitivity to study drug or excipients,
  • Pregnant or lactating,
  • Ongoing active infection

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