Drugs in development · updated 13 November 2026
GI-102: clinical trials and development status
As of 13 November 2026 GI-102 is in 3 active clinical trials (recruiting or ongoing, phases I–III) for 6 diseases. The most advanced phase is II.
Authorisation
- EU no (EMA)
- Italy not in the AIFA register
- Germany not available
- US no (FDA)
Sources: EMA, AIFA register (open data), FDA. For Germany only the EU centralised authorisation is shown: the national BfArM register is not one of our sources.
Map of sites in Europe with recruitment status, every trial and an email when something changes. Full access free until 31 March 2027, no card needed.
What it is
A bi-specific Fc fusion protein composed of the N-terminal ectodomain of human CD80 (B7.1) fused to a human immunoglobulin G4 (IgG4) Fc fragment and linked to an interleukin (IL)-2 variant (IL-2v) as a C-terminal moiety, with potential immunostimulatory, immune checkpoint inhibitory and antineoplastic activities. Upon administration of bispecific CD80-IgG4Fc-IL-2v fusion protein GI-102, the CD80 moiety targets and binds to cytotoxic T-lymphocyte-associated antigen 4 (CTLA4; CTLA-4) expressed on T-cells. This prevents the binding of CTLA-4 to endogenous CD80, enables the binding of CD80 to CD28, which leads to CD28-mediated signaling, and results in the activation of T-cells in the tumor microenvironment (TME). This promotes T-cell activity. The IL-2v moiety may stimulate a local immune response and activate natural killer (NK) cells and cytotoxic T-cells. This may enhance the activity of neoantigen specific T-cells and potentiates the T-cell-mediated immune response against tumor cells.
Diseases studied
For each disease: the drug’s most advanced phase and active trials, with the reference trial on ClinicalTrials.gov.
| Disease | Most advanced phase | Active trials | Reference trial |
|---|---|---|---|
| Colorectal neoplasm | I–II | 1 | NCT05824975 |
| Hepatocellular carcinoma | I–II | 1 | NCT05824975 |
| Melanoma | I–II | 1 | NCT05824975 |
| Metastasis | I–II | 1 | NCT05824975 |
| Renal cell carcinoma | I–II | 1 | NCT05824975 |
| Sarcoma | I–II | 1 | NCT05824975 |
Everything on GI-102
In Phuturdex you get every trial with sponsors, countries and dates, development events, FDA and EMA approvals, patents and exclusivities, orphan designations and safety alerts, with PDF and Excel export. Free until 31 March 2027.
Open in Phuturdex →Source: Phuturdex analysis of ClinicalTrials.gov (U.S. National Library of Medicine), FDA and EMA data, updated 13 November 2026. Active trials = recruiting or ongoing, phases I–III. Diseases are those named by each trial (NLM MeSH terms). The estimated launch, when shown, refers to the United States and is a Phuturdex calculation described on the Method page, not official data: the drug may already be marketed in other countries.