175 Participants NeededMy employer runs this trial

GTB-5550 for Cancer

NZ
Overseen ByNicholas Zorko, MD
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Masonic Cancer Center, University of Minnesota
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment called GTB-5550 for individuals with certain advanced or metastatic cancers. GTB-5550 targets cancer cells with a specific marker known as B7-H3. The trial seeks to determine the safety of the treatment and its potential effectiveness against these cancers. Individuals with advanced cancer unresponsive to other treatments and with a cancer type exhibiting high levels of B7-H3 may be suitable candidates for this trial. Participants will receive varying doses of GTB-5550 to identify the most effective and safe dose. As a Phase 1 trial, this research focuses on understanding how GTB-5550 works in people, offering participants the opportunity to be among the first to receive this innovative treatment.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, you cannot have had any anti-cancer treatment, including surgery, radiotherapy, chemotherapy, or other immunotherapy, within 14 days before starting the trial. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that GTB-5550 is likely to be safe for humans?

Research has shown that GTB-5550, the treatment under study, is in the early stages of human testing. This means limited information exists about its safety for humans. At this stage, treatments are primarily tested to assess safety and the body's response.

GTB-5550 is a TriSpecific Killer Engager (TriKE) designed to help the immune system identify and destroy cancer cells. Although GTB-5550 is being tested in humans for the first time, similar treatments have been well-tolerated previously. For instance, GTB-3550 was found to be safe and tolerable in earlier studies.

Since GTB-5550 is in a Phase 1 trial, researchers closely monitor for any side effects. They will make changes to improve safety if any issues arise.

While solid safety data for GTB-5550 in humans is not yet available, the success of similar treatments in the past provides some reassurance about its potential safety. Participants will be carefully observed to ensure their well-being during the trial.12345

Why do researchers think this study treatment might be promising?

Researchers are excited about GTB-5550 because it offers a new approach to treating advanced or metastatic cancer. Unlike traditional treatments such as chemotherapy and radiation, which can affect healthy cells, GTB-5550 targets cancer cells more selectively. This precision reduces the potential for side effects and improves the overall effectiveness of the treatment. Additionally, GTB-5550 is being tested in various dose levels, which helps researchers find the optimal dosage to maximize benefits while minimizing risks. This innovative approach holds promise for improving outcomes for patients with difficult-to-treat cancers.

What evidence suggests that GTB-5550 might be an effective treatment for cancer?

Studies have shown that GTB-5550 targets a protein called B7-H3, found in many solid tumors. This protein often appears in advanced cancers, making it a promising treatment target. GTB-5550 guides the body’s natural killer (NK) cells to attack cancer cells. Early research in labs and animals has shown positive results, suggesting it might help reduce tumor growth. Although human studies provide limited information, the mechanism of GTB-5550 offers strong reason to believe it could be effective against cancers with the B7-H3 protein. Participants in this trial will receive varying doses of GTB-5550 to evaluate its safety and effectiveness.13678

Are You a Good Fit for This Trial?

This trial is for adults (18+) with advanced or metastatic solid tumors that have high B7-H3 expression. Participants must have tried and not benefited from standard treatments, be in generally stable health, and meet specific heart, liver, kidney, lung, and blood test requirements.

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).
See 7 more

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

Trial Overview

The study is testing GTB-5550, a new drug designed to help the immune system target cancer cells by engaging natural killer cells. This early-phase trial will assess safety and how the body responds to different doses in people with certain solid tumors.

How Is the Trial Designed?

6

Treatment groups

Experimental Treatment

Group I: Dose Level Cohort 5Experimental Treatment1 Intervention
Group II: Dose Level Cohort 4Experimental Treatment1 Intervention
Group III: Dose Level Cohort 3Experimental Treatment1 Intervention
Group IV: Dose Level Cohort 2Experimental Treatment1 Intervention
Group V: Dose Level Cohort 1Experimental Treatment1 Intervention
Group VI: Dose Level Cohort -1Experimental Treatment1 Intervention

Find a Clinic Near You

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+

Citations

NCT07541573 | GTB-5550 in Advanced Solid Tumors

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

Press Releases

The Phase 1 trial with GTB-5550 will be the first nanobody TriKE® tested with more patient-friendly subcutaneous dosing. The Phase 1a dose ...

GTB-5550: A Tri-specific NK Cell Engager Designed to Target ...

Zachary Klaassen is joined by Nicholas Zorko to discuss GTB-5550, a Tri-specific Killer Engager targeting B7-H3 in advanced prostate cancer.

GT Biopharma doses first patient in GTB-5550 Phase 1

The study includes a Phase 1a prostate cancer-focused dose escalation followed by a Phase 1b expansion across up to seven B7-H3–positive tumor ...

GT Biopharma Presented Positive Preclinical Data for GTB ...

GTB-5550 was specifically designed as a novel tri-specific killer engager (TriKE®) molecule with three components: an arm that engages with CD16 ...

Overview :: GT Biopharma, Inc. (GTBP)

In the completed Phase 1 clinical study, GTB-3550 was shown to be safe and well-tolerated. The study of GTB-3550 demonstrated clinical proof of concept of in ...

GTB-5550: A Tri-specific NK Cell Engager Designed to Target ...

GTB-5550 comprises three components: CD16 for natural killer cell engagement, interleukin-15 as a flexible linker providing necessary cytokine ...

GTB-5550 - Drug Targets, Indications, Patents

Based on supportive preclinical data, the planned Phase 1 trial with GTB-5550 will be the first dual nanobody TriKE® tested with more patient-friendly ...