Phase 1/2 Study of UI-102 in Selected Advanced Cancers

Purpose

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.

Condition

  • Advanced Cancer

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 1/Phase 2
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Sequential Assignment
Intervention Model Description
Initial dose escalation cohort followed by expansion and phase II study
Primary Purpose
Treatment
Masking
None (Open Label)
Masking Description
Open Label Multi Center Non Randomized Study

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
UI-102 Monotherapy, IV infusion 		UI-102 monotherapy administered intravenously. This arm includes Phase I dose escalation, backfill cohorts, and cohort expansion in participants with selected locally advanced and/or metastatic solid tumors.
  • Drug: UI-102
    Specified dose on specified days
Experimental
UI-102 Combination Therapy, IV infusion 		UI-102 administered intravenously in combination with standard-of-care agents commonly used. This arm includes dose escalation, dose optimization, and cohort expansion.
  • Drug: UI-102
    Specified dose on specified days

Recruiting Locations

NEXT Oncology
Dallas, Texas 75039
Contact:
Clinical Trial Navigator
972-893-8800
fakinwale@nextoncology.com

NEXT Oncology
Houston, Texas 77054
Contact:
Clinical Trial Navigator
832-384-7912
emorales@nextoncology.com

NEXT Oncology
San Antonio, Texas 78229
Contact:
Clinical Trial Navigator
210-580-9521
jgeorg@nextoncology.com

More Details

Status
Recruiting
Sponsor
United Immunity, co., Ltd.

Study Contact

K Hashimoto, MD
+81 (0)3-6265-1670
clinical-contact@unitedimmunity.co.jp

Detailed Description

This phase 1/2 , open-labelled, multi-center study is designed to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics, and preliminary clinical activities of UI-102 in patients with advanced solid tumors. Phase 2 part is designed to assess the efficacy and safety as well as to optimize the dosing amount of UI-102