OncoMatch/Clinical Trials/NCT07376707
A Phase 1 Study of TGI-5 as Monotherapy and in Combination With Nivolumab in Subjects With Locally Advanced/Metastatic Solid Tumors
Is NCT07376707 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies TGI-5 for crc (colorectal cancer).
Treatment: TGI-5 — This is a Phase 1, multicenter, open-label, two-parts, FIH study to evaluate the tolerability, safety, PK/PD, and preliminary antitumor activity of TGI-5 as monotherapy and in combination with Nivolumab in subjects with unresectable locally advanced/metastatic solid tumors. The study consists of two parts: TGI-5 monotherapy (Phase 1a: including a dose escalation part and a dose expansion part), TGI-5 in combination with a fixed dose of Nivolumab (Phase 1b: including a dose escalation part and a dose expansion part).
Check if I qualifyExtracted eligibility criteria
Cancer type
Colorectal Cancer
Melanoma
Hepatocellular Carcinoma
Non-Small Cell Lung Carcinoma
Biomarker criteria
Required: KRAS wild-type
KRAS wild-type
Required: EGFR wild-type
KRAS wild-type subjects if clinically indicated
Required: BRAF V600 mutation
patients with BRAF V600 mutations
Required: PD-L1 (CD274) expression ≥1% (≥1%)
All subject in Phase 1b must meet PD-L1 expression ≥1%
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: TIGIT-targeting therapy
Previous treated with TIGIT-targeting therapy
Lab requirements
Blood counts
ANC ≥1.5×10^9/L. Hemoglobin (HGB) ≥90 g/L. Platelet (PLT) ≥75×10^9/L.
Kidney function
Creatinine apparent clearance (CL) >50 mL/min according to modification Cockcroft-Gault equation
Liver function
AST and ALT ≤2.5×ULN (≤5×ULN for subjects with liver metastases). Total bilirubin (TBil) ≤1.5×ULN, or TBil ≤3.0×ULN for subjects with liver cancer or liver metastases. Subjects with Gilbert's syndrome may enroll if direct bilirubin ≤1.5×ULN.
Cardiac function
NYHA class III or IV congestive heart failure excluded. LVEF <50% excluded. QTcF >480 ms excluded. Uncontrolled hypertension excluded. Symptomatic pulmonary embolism within 6 months excluded.
Subjects have sufficient baseline organ function and laboratory data meet the following criteria at enrollment: Hematological: ANC ≥1.5×10^9/L; Hemoglobin (HGB) ≥90 g/L; Platelet (PLT) ≥75×10^9/L. Hepatic: AST and ALT ≤2.5×ULN (≤5×ULN for subjects with liver metastases); Total bilirubin (TBil) ≤1.5×ULN, or TBil ≤3.0×ULN for subjects with liver cancer or liver metastases. Renal: Creatinine apparent clearance (CL) >50 mL/min. Coagulation: INR ≤1.5; APTT ≤1.5×ULN.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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