Drugs / GTB-5550
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | — | B7-H3 expressing solid tumor cancers | — | “today announced the submission of an investigational new drug (IND) application to the U.S. Food and Drug Administration (FDA) in December 2025 for GTB-5550 TriKE” gtbiopharma.com ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1 | NCT07541573 | Apr 2026 → Jan 2031 expected | cancer | Masonic Cancer Center, University of Minnesota | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 9
| Date | Issuer | Release |
|---|---|---|
| 2026-09-15 | GT Biopharma, Inc. | Regulatory GT Biopharma Announces Potential New Indication for GTB-5550, a B7-H3-Targeted Natural Killer (NK) Cell Engager, for Multiple Myeloma gtbiopharma.com ↗
“Today’s IND to expand the potential indications for GTB-5550 highlights the diverse utility of our Trike® platform,” said Michael Breen, Executive Chairman and Chief Executive Officer of GT Biopharma. |
| 2026-02-03 | GT Biopharma, Inc. | Regulatory GT Biopharma Announces FDA Clearance of Investigational New Drug (IND) Application for GTB-5550 TriKE®, a B7-H3-Targeted Natural Killer (NK) Cell Engager for Solid Tumors Expressing B7-H3 gtbiopharma.com ↗
GT Biopharma, Inc. (the “Company”) (NASDAQ: GTBP), a clinical stage immuno-oncology company focused on developing innovative therapeutics based on the Company's proprietary TriKE® natural killer (NK) cell engager platform, today announced FDA clearance of its IND application for GTB-5550, allowing the company to proceed with a Phase 1 clinical trial, which is anticipated to initiate in mid-2026. |
| 2026-01-15 | GT Biopharma, Inc. | Regulatory GT Biopharma Announces IND Submission for GTB-5550 TriKE®, a B7-H3-targeted natural killer (NK) cell engager for B7-H3 expressing solid tumor cancers gtbiopharma.com ↗
GT Biopharma, Inc. (the “Company”) (NASDAQ: GTBP), a clinical stage immuno-oncology company focused on developing innovative therapeutics based on the Company's proprietary TriKE® natural killer (NK) cell engager platform, today announced the submission of an investigational new drug (IND) application to the U.S. Food and Drug Administration (FDA) in December 2025 for GTB-5550 TriKE, a B7-H3-targeted natural killer (NK) cell engager for the treatment of B7-H3 expressing solid tumor cancers. |
| 2023-11-06 | GT Biopharma, Inc. | Results GT Biopharma Presented Positive Preclinical Data for GTB-5550, a Novel TriKE® Molecule for Targeted Prostate Cancer Treatment During the Society for Immunotherapy of Cancer (SITC) 2023 Annual Meeting gtbiopharma.com ↗
GT Biopharma, Inc. (NASDAQ: GTBP), a clinical stage immuno-oncology company focused on developing innovative therapeutics based on the Company's proprietary natural killer (NK) cell engager, TriKE® platform, today announced positive preclinical data in highlighting GTB-5550’s potential in prostate cancer. |
| 2022-09-12 | GT Biopharma, Inc. | Results GT Biopharma Poster Presentation and Mini Oral Session at ESMO Congress 2022 Demonstrates GTB-5550 TriKE® Ability to Specifically Target and Efficiently Kill Multiple B7H3+ Solid and Hematologic Malignancies gtbiopharma.com ↗
GTB-5550 effectively induced NK cell degranulation and interferon gamma production in response to various prostate, brain tumor (atypical rhabdoid/teratoid), HNSCC, multiple myeloma, sarcoma, ovarian, and myeloid malignancies |
| 2022-04-11 | GT Biopharma, Inc. | Results GT Biopharma Presents Preclinical Data Demonstrating Novel B7H3+ Tumor Targeting GTB-5550 TriKE® Driving NK Cell Activation and ADCC Against Head and Neck Squamous Cell Carcinomas at AACR Annual Meeting 2022 gtbiopharma.com ↗
GTB-5550 also induced more HNSCC target cell killing by NK cells compared to treatment with the B7H3 single domain or IL-15 alone irrespective of the FANCA gene, both in 2D and 3D IncuCyte imaging assays. |
| 2022-03-21 | GT Biopharma, Inc. | Results GT Biopharma Presents TriKE® Nanobody Pipeline (GTB-5550) Preclinical Multiple Myeloma Proof-of-Concept Data at 2022 EBMT Annual Meeting gtbiopharma.com ↗
Testing GTB-5550 across several multiple myeloma cell-lines has yielded preclinical evidence suggesting further investigation of this TriKE in the clinic. |
| 2021-12-08 | GT Biopharma, Inc. | Results GT Biopharma Demonstrates Novel B7-H3 Targeting Dual Camelid Nanobody BiKE and GTB-5550 Induce NK Cell Activation Against Broad Spectrum of Tumors at ESMO IO Congress 2021 gtbiopharma.com ↗
Compared to monomeric IL-15, GTB-5550 shows CD16-dependent metabolic activation of NK cells. |
| 2021-08-03 | GT Biopharma, Inc. | Results GT Biopharma Announces Positive Preclinical Results For GTB-5550 B7H3 TriKE™ gtbiopharma.com ↗
GTB-5550 TriKE™ was evaluated in several preclinical models overexpressing B7H3, and was found to be effective at promoting NK cell killing of multiple cancer cell types. |
All press releases naming this drug 10 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | GTB-5550 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT07541573 ↗ |
| Modality | Protein / enzyme biologic | “is a single chain recombinant TriKE comprised of three components joined by flexible linkers to form a molecule” NCT07541573 ↗ |
| Route | Subcutaneous | “GTB-5550 is administered by subcutaneous (SQ) injection in the abdominal area” NCT07541573 ↗ |