GTB-5550 for Cancer

Overseen By Nicholas Zorko, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Masonic Cancer Center, University of Minnesota

Must not be taking: Immunosuppressants, Parenteral antibiotics

Disqualifiers: Pregnancy, Autoimmune disease, Transplant, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 8

175 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Are You a Good Fit for This Trial?

Inclusion Criteria

I am 18 or older and can care for myself daily.

* Acute effects of any prior therapy must have resolved to baseline or Grade ≤ 1 NCI CTCAE v5 except for AEs not constituting a safety risk in the opinion of the enrolling Investigator.

* Measurable disease per RECIST 1.1. (Exception: mCRPC limited to bone metastasis is exempt from this requirement).

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1a: Dose Escalation

Open-label component testing up to 6 dose levels of GTB-5550 to identify the MTD using an adaptation of the BOIN design

8 weeks

5 consecutive days of treatment followed by 2 weeks off, repeated for 2 cycles

Phase 1b: Dose Expansion

Confirm the MTD identified in Phase 1a across 7 distinct metastatic disease cohorts and further evaluate tolerability

8 weeks

3 times per week for 2 weeks followed by 2 weeks off, repeated for 2 cycles

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

What Are the Treatments Tested in This Trial?

Interventions

• GTB-5550

How Is the Trial Designed?

Group I: Dose Level Cohort 5 Experimental Treatment 1 Intervention

Patients with histologically or cytologically confirmed advanced/metastatic cancer. Patients will receive 9000 µg (or 2000 µL) of GTB-5550.

Group II: Dose Level Cohort 4 Experimental Treatment 1 Intervention

Patients with histologically or cytologically confirmed advanced/metastatic cancer. Patients will receive 5400 µg (or 1200 µL) of GTB-5550.

Group III: Dose Level Cohort 3 Experimental Treatment 1 Intervention

Patients with histologically or cytologically confirmed advanced/metastatic cancer. Patients will receive 2700 µg (or 600 µL) of GTB-5550.

Group IV: Dose Level Cohort 2 Experimental Treatment 1 Intervention

Patients with histologically or cytologically confirmed advanced/metastatic cancer. Patients will receive 900 µg (or 200 µL) of GTB-5550.

Group V: Dose Level Cohort 1 Experimental Treatment 1 Intervention

Patients with histologically or cytologically confirmed advanced/metastatic cancer. Patients will receive 270 µg (or 60 µL) of GTB-5550.

Group VI: Dose Level Cohort -1 Experimental Treatment 1 Intervention

Patients with histologically or cytologically confirmed advanced/metastatic cancer. Patients will receive 90 µg (or 20 µL) of GTB-5550.

Who Is Running the Clinical Trial?

Masonic Cancer Center, University of Minnesota

Lead Sponsor

Trials

285

Recruited

15,700+

GT Biopharma, Inc.

Industry Sponsor

Trials

1

Recruited

10+