A Phase 1 Study to Evaluate TGI-6 in Subjects With Locally Advanced/Metastatic Solid Tumors

Required: NCR3LG1 overexpression (B7-H6-positive)

confirmed B7-H6-positive unresectable locally advanced/metastatic solid tumors

Must have received: all standard therapy

Subjects should have progressed despite all standard therapy or be intolerant of all standard therapy, or for whom no standard therapy exists

Cannot have received: B7-H6-targeting therapy

Previous treated with any B7-H6-targeting therapy

Cannot have received: chemotherapy

Exception: within 28 days or 5 half-lives, whichever is shorter, prior to the first dose of study treatment

Chemotherapy, target therapy, immunotherapy, or other anticancer therapy within 28 days or 5 half-lives, whichever is shorter, prior to the first dose of study treatment

Cannot have received: targeted therapy

Exception: within 28 days or 5 half-lives, whichever is shorter, prior to the first dose of study treatment

Chemotherapy, target therapy, immunotherapy, or other anticancer therapy within 28 days or 5 half-lives, whichever is shorter, prior to the first dose of study treatment

Cannot have received: immunotherapy

Exception: within 28 days or 5 half-lives, whichever is shorter, prior to the first dose of study treatment

Chemotherapy, target therapy, immunotherapy, or other anticancer therapy within 28 days or 5 half-lives, whichever is shorter, prior to the first dose of study treatment

Cannot have received: anticancer therapy

Exception: within 28 days or 5 half-lives, whichever is shorter, prior to the first dose of study treatment

Chemotherapy, target therapy, immunotherapy, or other anticancer therapy within 28 days or 5 half-lives, whichever is shorter, prior to the first dose of study treatment

Cannot have received: nitrosoureas

Exception: washout period ≤6 weeks

Washout period for nitrosoureas or mitomycin is ≤6 weeks

Cannot have received: mitomycin

Exception: washout period ≤6 weeks

Washout period for nitrosoureas or mitomycin is ≤6 weeks

Cannot have received: fluoropyrimidines

Exception: ≤5 half-lives or 2 weeks (whichever is longer)

≤5 half-lives or 2 weeks (whichever is longer) for fluoropyrimidines or small-molecule targeted agents

Cannot have received: small-molecule targeted agents

Exception: ≤5 half-lives or 2 weeks (whichever is longer)

≤5 half-lives or 2 weeks (whichever is longer) for fluoropyrimidines or small-molecule targeted agents

Cannot have received: herbal therapy with anticancer indications

Exception: washout period ≤2 weeks

Washout period for herbal therapy with anticancer indications is ≤2 weeks

Cannot have received: radiotherapy

Exception: ≤4 weeks prior to the first dose of study treatment, except a single fraction for palliation

Prior radiotherapy ≤4 weeks prior to the first dose of study treatment, with the exception of a single fraction of radiotherapy for the purposes of palliation, which is permitted

Cannot have received: investigational product

Exception: within 28 days prior to the first dose of TGI-6

Subject participated in any other clinical study and has received an investigational product within 28 days prior to the first dose of TGI-6

Cannot have received: systematic immunomodulatory drugs (thymosin, IL-2, interferon)

Exception: within 14 days before the first dose of study drug

Has received systematic immunomodulatory drugs within 14 days before the first dose of study drug, such as thymosin, IL-2, and interferon (IFN)

Cannot have received: live vaccine

Exception: within 4 weeks prior to the first dose of study drug

Has received a live vaccine within 4 weeks prior to the first dose of study drug