GTB-5550 in Advanced Solid Tumors

Part of paid clinical trials in Minneapolis, Minnesota.

Sponsor
Masonic Cancer Center, University of Minnesota
Study ID
NCT07541573
Phase
PHASE1
Status
Recruiting
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Conditions

  • Advanced Solid Tumor
  • Solid Tumor
  • Tri-specific Killer Engager

Eligibility Criteria

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

Interventions

  • GTB-5550 — DRUG
    GTB-5550 is given as a subcutaneous (SQ) injection in the abdominal area at the patient-assigned dose once a day for 5 consecutive days for 2 weeks in a row (i.e. Day 1-5 and Day 8-12) followed by 2 weeks of no treatment. This 4-week period equals 1 treatment cycle, or 28 days. Starting with Cycle 2 and beyond, this will be repeated with three times per week dosing for weeks 1 and 2 of the cycle (but not on 3 consecutive days) followed by 2 weeks of no treatment.

Study Details

This is a first-in-human Phase 1a/1b trial of a B7-H3-targeted natural killer (NK) cell engager, referred to as a TriSpecific Killer Engager (TriKE), for the treatment of select solid tumor cancers. To be considered for the study, a patient must be 18 years or older, have histologically or cytologically confirmed advanced/metastatic cancer that, based on literature reports, expresses B7-H3 at a high frequency, measurable disease by RECIST 1.1 (exception: mCRPC limited to bone metastasis are exempt from this requirement), meets the disease specific criteria for prior failed therapy, and refractory to, intolerant of, or ineligible for therapy options that are known to provide clinical benefit for their diagnosis.

Key Dates

Start date
Apr 8, 2026
Status verified
Apr 2026
Primary completion
Jan 31, 2031
Completion
Jan 31, 2032

Study Design

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

Arms

  • Experimental: Dose Level Cohort -1
    Patients with histologically or cytologically confirmed advanced/metastatic cancer. Patients will receive 90 µg (or 20 µL) of GTB-5550.
  • Experimental: Dose Level Cohort 1
    Patients with histologically or cytologically confirmed advanced/metastatic cancer. Patients will receive 270 µg (or 60 µL) of GTB-5550.
  • Experimental: Dose Level Cohort 2
    Patients with histologically or cytologically confirmed advanced/metastatic cancer. Patients will receive 900 µg (or 200 µL) of GTB-5550.
  • Experimental: Dose Level Cohort 3
    Patients with histologically or cytologically confirmed advanced/metastatic cancer. Patients will receive 2700 µg (or 600 µL) of GTB-5550.
  • Experimental: Dose Level Cohort 4
    Patients with histologically or cytologically confirmed advanced/metastatic cancer. Patients will receive 5400 µg (or 1200 µL) of GTB-5550.
  • Experimental: Dose Level Cohort 5
    Patients with histologically or cytologically confirmed advanced/metastatic cancer. Patients will receive 9000 µg (or 2000 µL) of GTB-5550.

Primary Outcome Measure

Maximum tolerated dose (MTD) [ Time Frame: 1 year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Masonic Cancer Center at University of MinnesotaMinneapolisMinnesota55455
Nicholas Zorko, MD

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By research site
Masonic Cancer Center at University of Minnesota· Minneapolis, MN

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