Phase 1/2 Study of TU2218 Alone and in Combination With Checkpoint Inhibitors in Patients With Advanced Solid Tumors

Part of paid clinical trials in San Antonio, Texas.

Sponsor
TiumBio Co., Ltd.
Study ID
NCT05204862
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Advanced Solid Tumor

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • TU2218 — DRUG
    orally administered
  • Anti-PD-1 antibody — DRUG
    Intravenously administered

Study Details

This study consists of Part A for monotherapy and Part B for combination therapy to evaluate safety, tolerability, pharmacokinetics, and preliminary efficacy of TU2218 in patients with advanced solid tumors. The main purpose of Phase 1 is to determined the recommended Phase 2 dose (RP2D) of TU2218 and the main purpose of Phase 2 is to evaluate the antitumor activity of TU2218 at RP2D.

Key Dates

Start date
Dec 2, 2021
Status verified
Mar 2023
Primary completion
Jun 30, 2026
Completion
Sep 30, 2027

Study Design

Enrollment
240 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: TU2218 Phase 1a
    Escalating doses of TU2218 orally administered daily for two weeks followed by one week of rest for up to 21-day cycles
  • Experimental: TU2218 Food Effect
    TU2218 orally administered at a one dose level below MTD under fasting condition on -Day 2, followed by the same dose orally administered with meals on -Day 1 and then continued under fasted condition for two weeks followed by one week of rest for up to 21-day cycles
  • Experimental: TU2218 + Anti-PD-1 antibody Phase 1b
    Escalating doses of TU2218 in combination with anti-PD-1 antibody up to 21-day cycles
  • Experimental: TU2218 Phase 2a
    TU2218 at a RP2D orally administered daily for two weeks followed by on week of rest for up to 21-day cycles
  • Experimental: TU2218 + Anti-PD-1 antibody Phase 2b
    TU2218 at a RP2DC in combination with anti-PD-1 antibody up to 21-day cycles

Primary Outcome Measure

Phase 1: Maximum Tolerated Dose (MTD) of TU2218 administered alone (Part A) and in combination with anti-PD-1 antibody (Part B) [ Time Frame: From the beginning of Cycle 1 through Cycle 2 (each cycle is 21 days) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
NEXT OncologySan AntonioTexas78229-

Find similar trials in San Antonio, TX

By research site
NEXT Oncology· San Antonio, TX

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