Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT07541573

GTB-5550 in Advanced Solid Tumors

Led by Masonic Cancer Center, University of Minnesota · Updated on 2026-04-23

175

Participants Needed

1

Research Sites

299 weeks

Total Duration

On this page

Sponsors

M

Masonic Cancer Center, University of Minnesota

Lead Sponsor

G

GT Biopharma, Inc.

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

GTB-5550 in Advanced Solid Tumors

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Measurable disease per RECIST 1.1 (except mCRPC limited to bone metastasis)
  • Age 18 years or older with ECOG Performance Status 0 to 2
  • Acute effects of prior therapy resolved to baseline or Grade 61; 1 except non-safety risk adverse events
  • Adequate organ function within 14 days (30 days for cardiac) before Cycle 1 Day 1:
    • Hemoglobin 61; 9 g/dL (with limited transfusion allowed)
    • Absolute neutrophil count 61; 1500/ul (no recent growth factor use)
    • Platelets 61; 100 x 10^9/L (with limited transfusion allowed)
    • Absolute lymphocyte count 61; 300/ul
    • Albumin 61; 3.0 g/dL
    • Renal: GFR 61; 45 mL/min (BSA corrected)
    • Hepatic: AST and ALT 64; 1.5 x ULN; total bilirubin 64; 1.5 x ULN
    • Cardiac: NYHA Class I or II; LVEF 61; 45%
    • Pulmonary: PFTs > 50% FEV1 if symptomatic or impaired
  • Sexually active patients with childbearing potential must use effective contraception or abstinence during and for 4 months after treatment
  • Willing to remain within 60-minute drive of study center through Cycle 1 Day 15 (Phase 1a only)
  • Provides voluntary written consent before any study procedures
Not Eligible

You will not qualify if you...

  • Anti-cancer treatment within 14 days prior to first GTB-5550 dose (longer washout for radioligand therapy)
  • Prior organ allograft or allogeneic transplant (except certain FA patients off immunosuppression >1 year)
  • Pregnant, breastfeeding, or planning pregnancy within 4 months after last GTB-5550 dose
  • QTc interval > 480 msec at screening or family history of long QT syndrome
  • Prior malignancy other than current cancer unless in complete remission for at least 1 year
  • Active autoimmune disease requiring systemic treatment within past year or immunosuppressive therapy during study
  • Active systemic infection requiring IV antibiotics
  • Psychiatric or social conditions limiting study compliance
  • Other medical issues deemed exclusionary by investigator

AI-Screening

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Trial Site Locations

Total: 1 location

1

Masonic Cancer Center at University of Minnesota

Minneapolis, Minnesota, United States, 55455

Actively Recruiting

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Research Team

N

Nicholas Zorko, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

6

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