Actively Recruiting
A Phase 1 Study to Investigate the Safety, Tolerability, Pharmacokinetics/Pharmacodynamics, and Antitumor Activity 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
8 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
Researchers are evaluating the safety, tolerability, pharmacokinetics/pharmacodynamics (PK/PD), and preliminary antitumor effects of a drug called TGI-5 given alone and combined with another drug, Nivolumab, in adults with unresectable locally advanced or metastatic solid tumors. This Phase 1 study includes patients with colorectal cancer, hepatocellular carcinoma, melanoma, non-small cell lung cancer, and other solid tumors who have not responded to or cannot tolerate standard treatments. The study has two parts: Phase 1a tests TGI-5 alone starting at a low dose with gradual increases to find the best dose, given every two weeks via intravenous infusion. Phase 1b tests TGI-5 combined with a fixed dose of Nivolumab, also given every two weeks. Each part includes dose escalation to find safe doses and dose expansion to further assess safety and antitumor activity in specific tumor groups. Treatment continues every two weeks unless stopped for progression, side effects, or other reasons. Participants will undergo screening and then receive scheduled infusions of TGI-5 alone or with Nivolumab. They will be monitored for side effects including dose-limiting toxicities during the first 28 days of treatment and have regular assessments of safety, drug levels, and tumor response. The study tracks adverse events from screening until 30 days after the last dose and follows tumor response for about two years. Treatment may be stopped based on disease progression, toxicity, or other factors, with close monitoring throughout.
CONDITIONS
Brief 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 informed 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 all standard therapies, intolerance to standard therapies, or no effective standard therapy available.
- For colorectal cancer cohort: at least two prior chemotherapy regimens including fluoropyrimidine, oxaliplatin, irinotecan, with or without anti-VEGF or anti-EGFR therapies as appropriate.
- For melanoma cohort: relapsed or refractory to anti-PD-1 antibody treatment with at least two doses received.
- For non-small cell lung cancer cohort: relapsed or refractory to anti-PD-(L)1 inhibitors with at least two doses received and prior platinum-based chemotherapy.
- At least one measurable or evaluable tumor lesion not treated by recent radiotherapy.
- ECOG performance status of 0 to 2.
- Life expectancy of at least 3 months.
- Adequate organ function as defined by laboratory criteria.
- Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception; same for male participants with partners of childbearing potential.
You will not qualify if you...
- Known active central nervous system primary tumor or metastases unless clinically stable for at least 2 weeks.
- Active infections including hepatitis B or C, or HIV unless stable with adequate immune function.
- History of active autoimmune disease or recent immunosuppressive therapy.
- History of symptomatic interstitial lung disease.
- Unresolved toxicities from prior therapies except specific mild conditions.
- Severe or uncontrolled cardiovascular disease.
- Prior bone marrow or solid organ transplantation.
- Another progressing malignancy requiring treatment within past 3 years.
- Clinically significant immunosuppression.
- Uncontrolled pleural, pericardial effusion, or ascites requiring frequent drainage.
- Recent chemotherapy, radiotherapy, or investigational drug use within defined washout periods.
- Use of systemic immunomodulatory drugs or live vaccines within specified timeframes.
- Recent major surgery or planned surgery during the study.
- Need for anticoagulant treatment that cannot be safely interrupted.
- History of severe immune-related adverse events or immunotherapy discontinuation due to toxicity.
- 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.
- Inability or unwillingness to comply with study procedures.
- Contraindication for use of PD-1/PD-L1 antibodies (for combination phase).
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 28-day cycles until discontinuation
Participants receive TGI-5 as monotherapy or in combination with Nivolumab by intravenous infusion once every 2 weeks (Q2W). The initial 28-day period is an evaluation phase for dose-limiting toxicities (DLTs). Participants who do not experience DLTs continue treatment until disease progression, unacceptable toxicity, withdrawal, or other reasons.
Visits every 2 weeks for dosing and monitoring
Trial Site Locations
Total: 1 location
1
Fudan University Shanghai Cancer Center
Shanghai, China
Actively Recruiting
Research Team
H
Hang Zhou, Bachelor
X
Xiaohu Zheng, Doctorate
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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