Actively Recruiting
A Phase 1 Study of TGI-5 as Monotherapy and in Combination With Nivolumab in Subjects With Locally Advanced/Metastatic Solid Tumors
Led by Hefei TG ImmunoPharma Co., Ltd. · Updated on 2026-01-29
194
Participants Needed
1
Research Sites
133 weeks
Total Duration
On this page
Sponsors
H
Hefei TG ImmunoPharma Co., Ltd.
Lead Sponsor
T
Tigermed Consulting Co., Ltd
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
A Phase 1 Study of TGI-5 as Monotherapy and in Combination With Nivolumab in Subjects With Locally Advanced/Metastatic Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 years or older at the time of consent
- Diagnosed with unresectable locally advanced or metastatic solid tumors (mainly colorectal cancer, hepatocellular carcinoma, melanoma, or non-small cell lung cancer)
- Disease progression despite standard therapy, intolerance to standard therapy, or no effective standard therapy available
- For Dose Expansion Phase 1b: specific cohorts with histologically or cytologically confirmed unresectable locally advanced/metastatic colorectal cancer, melanoma, non-small cell lung cancer, or other solid tumors
- At least 2 prior chemotherapy regimens for colorectal cancer cohort with documented progression or intolerance
- ECOG performance status of 0 to 2
- Life expectancy of at least 3 months
- Adequate organ function and laboratory values as specified
- Negative pregnancy test for women of childbearing potential
- Agreement to use effective contraception during study and for 6 months after last dose
You will not qualify if you...
- Active central nervous system primary tumor or metastases unless clinically stable for at least 2 weeks without new or enlarging brain metastases and no recent steroid dose increase
- Active hepatitis B or C infection
- History of AIDS or HIV infection unless CD4+ T cell counts are ≥350 cells/µL without AIDS-defining infections
- Severe or active infections or fever >38°C within 7 days before first dose
- Active autoimmune diseases or recent immunosuppressive therapy
- History of symptomatic interstitial lung disease
- Unresolved toxicities from prior therapies except specific controlled conditions
- Severe or uncontrolled cardiovascular conditions
- Previous bone marrow or organ transplantation
- Other active malignancies requiring treatment within past 3 years (exceptions apply)
- Clinically significant immunosuppression or opportunistic infections
- Uncontrolled pleural, pericardial effusion, or ascites requiring frequent drainage
- Recent anticancer therapies, live vaccines, or immunomodulatory drugs within specified washout periods
- Recent major surgery or expected surgery during study
- Need for anticoagulant treatment that cannot be safely interrupted
- Prior severe immune-related adverse events from immunotherapies
- Psychiatric or substance abuse disorders interfering with study participation
- Pregnancy or lactation
- Known hypersensitivity to study drugs or ingredients
- Serious uncontrolled medical conditions that may interfere with study or increase risk
- Unable or unwilling to comply with study procedures
- Contraindications to PD-1/PD-L1 antibody use (Phase 1b only)
AI-Screening
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Trial Site Locations
Total: 1 location
1
Fudan University Shanghai Cancer Center
Shanghai, China
Actively Recruiting
Research Team
H
Hang Zhou, Bachelor
CONTACT
X
Xiaohu Zheng, Doctorate
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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