An open-label, multicenter, dose escalation and expansion phase 1/2 study to evaluatethe safety, tolerability and pharmacokinetics, and anti-tumor activity of GI-102, a CD80-IgG4Fc-IL-2v bispecific fusion protein, as a single agent and in combination with
Contact:
NCT Number:
Protocol:
Study Status:
Population:
Phase:
This study will see if the study drug, GI-102, alone or in combination with conventional anti- cancer drugs, pembrolizumab or trastuzumab deruxtecan, has an effect on the tumor and whether it causes any side effects. This study is to test study drugs in people with all types of solid tumors (certain tumor types for some groups). Pembrolizumab, which is approved in the USA and some other countries, is available by prescription to treat several different cancers, but is not approved to treat all types of cancer in this study. GI-102 is still experimental and is not approved by any regulatory health agency (Food and Drug Administration [FDA]) for use in people with cancer. This is the first time for this drug to be used in human beings. Subjects will continue to receive the study drug(s) for up to 2 years unless the cancer gets worse, or they have serious side effects. The main study is composed of four parts, as below: • Part A: GI-102 study drug alone (monotherapy) (IV) • Part B: GI-102 alone(Subcutaneous (SC) injection) • Part C: GI-102 in combination with conventional anti-cancer drugs, pembrolizumab or trastuzumab deruxtecan (T-Dxd)
Are you Eligible? (Inclusion Criteria)
- Must be 18 years or older - Must be willing and able to comply with scheduled visits, treatment plans, laboratory tests, and procedures - Must have confirmed cancer diagnosis - Cannot be pregnant or trying to become pregnant

