Study of AUBE00 in Patients With Solid Tumors

Part of paid clinical trials in Grand Rapids, Michigan.

Sponsor
Chugai Pharmaceutical
Study ID
NCT07030959
Phase
PHASE1
Status
Recruiting
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Conditions

  • Solid Tumors

Eligibility Criteria

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

Interventions

  • AUBE00 — DRUG
    AUBE00 as an oral administration
  • Cetuximab — DRUG
    Cetuximab as an IV infusion

Study Details

This is a first-in-human, Phase I, open-label, multicenter, multinational study, designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, and anti-tumor activity of AUBE00 in patients with locally advanced or metastatic solid tumors.The total number of patients in this study will be approximately 90 to 130.

Key Dates

Start date
Jun 5, 2025
Status verified
Feb 2026
Primary completion
Dec 31, 2029
Completion
Dec 31, 2029

Study Design

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

Arms

  • Experimental: Part A: Dose Escalation part of AUBE00 monotherapy
    Patients will receive AUBE00 as an oral administration at escalated doses.
  • Experimental: Part B: Expansion part of AUBE00 monotherapy
    Patients will receive AUBE00 as an oral administration at multiple dose levels determined to be safe (including MTD).
  • Experimental: Part C: Dose-Escalation and Expansion part of AUBE00 in combination with Cetuximab
    Patients will receive AUBE00 as an oral administration in combination with cetuximab as an IV infusion at escalated doses or the recommended dose level.

Primary Outcome Measure

Adverse events of AUBE00 [Part A, B, C] [ Time Frame: From screening until study completion, treatment discontinuation or post-treatment follow up (up to approximately 55 months) ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
South Texas Accelerated Research Therapeutics (START) MidwestGrand RapidsMichigan49546-
The University of Texas MD Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Grand Rapids, MI

By research site
South Texas Accelerated Research Therapeutics (START) Midwest· Grand Rapids, MIThe University of Texas MD Anderson Cancer Center· Houston, TX

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