A Phase 1 Study to Evaluate TGI-6 in Subjects with Locally Advanced/Metastatic Solid Tumors
Male or female subjects age ≥18 years at the time of informed consent.
Phase 1a: Subjects with histologically or cytologically diagnosed unresectable locally advanced/metastatic CRC. Or subjects with confirmed B7-H6-positive unresectable locally advanced/metastatic solid tumors, mainly but not limited to TNBC, HCC, HNSCC, SCLC, OC, GC, pancreatic cancer, and melanoma.
Phase 1a or Phase1b Cohort 2: Subjects should have progressed despite all standard therapy or be intolerant of all standard therapy, or for whom no standard therapy exists. (Standard therapies are defined as treatments recommended by local guidelines, including, but not limited to, chemotherapy, radiation, target therapies based on mutation status, immunotherapy, and surgery in general).
All subjects except subjects with CRC must agree to the collection of tumor samples for confirmation of B7-H6 expression status in a central lab.
Subject with known active central nervous system (CNS) primary tumor or metastases.
History of intercurrent severe chronic or active infections.
Has a history of active autoimmune diseases .
Has a history of symptomatic interstitial lung disease.
Single group
TGI-6 Injection
DrugTGI-6 will be administered intravenously at a dose and schedule as specified for the respective study part and cohort.
Dose-limiting Toxicity (DLT)
The incidence of DLTs during the DLT assessment period.
Dose-Finding
Determination of the MTD or maximum tested dose, and the RP2D.
Frequency and Severity of Adverse Events (AE)
The incidences and percentages of patients experiencing AEs summarized by NCI CTCAE version 5.0 grade and by causality.
Pharmacokinetics of TGI-6
Maximum Plasma Concentration (Cmax)
Pharmacokinetics of TGI-6
Area Under the Curve (AUC)
Number of subjects with Anti-TGI-6 antibody positive
Immunogenicity of TGI-6 monotherapy
Objective Response Rate (ORR)
ORR according to RECIST v1.1
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