Actively Recruiting
A Phase 1 Study to Investigate the Safety, Tolerability, Pharmacokinetics/ Pharmacodynamics, and Antitumor Activity of TGI-6 as Monotherapy in Subjects With Locally Advanced/Metastatic Solid Tumors
Led by Hefei TG ImmunoPharma Co., Ltd. · Updated on 2024-04-18
123
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a Phase 1 study to assess the safety, tolerability, pharmacokinetics/pharmacodynamics (PK/PD), and preliminary anti-tumor effects of TGI-6 given alone to adults with unresectable locally advanced or metastatic colorectal cancer (CRC) or other B7-H6-positive solid tumors such as triple-negative breast cancer, liver cancer, head and neck cancers, small cell lung cancer, ovarian cancer, gastric cancer, pancreatic cancer, and melanoma. The study aims to understand how the drug behaves in the body and its potential to control tumor growth in these advanced cancers. The study includes two parts: Phase 1a focuses on dose escalation to find a safe and tolerable dose of TGI-6, while Phase 1b involves dose expansion to further evaluate safety and activity at the selected dose. TGI-6 is administered intravenously according to the dosing schedule specified for each part and cohort. Participants go through a screening period of up to 28 days before starting treatment, continue treatment until discontinuation, and then enter a follow-up period for safety and survival monitoring. Participants will have regular assessments including evaluations of adverse events, tumor response measured by RECIST criteria, pharmacokinetic sampling for TGI-6 levels, and antibody testing against TGI-6. Safety monitoring includes tracking dose-limiting toxicities within the first 21 days and adverse events up to 30 days after the last dose. The study also follows participants for up to approximately three years to assess tumor response rates, duration of response, disease control, progression-free survival, and overall survival. Women of childbearing potential and their partners must use effective contraception during and for six months after the study treatment.
CONDITIONS
Brief Title
A Phase 1 Study to Evaluate TGI-6 in Subjects With Locally Advanced/Metastatic Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female subjects aged 18 years or older at the time of informed consent.
- Subjects with histologically or cytologically confirmed unresectable locally advanced or metastatic colorectal cancer (CRC) or B7-H6-positive locally advanced/metastatic solid tumors.
- Subjects must have progressed after all standard therapies, be intolerant to them, or have no standard therapy available.
- Subjects with CRC must have at least one evaluable lesion; subjects in dose expansion must have at least one measurable lesion per RECIST v1.1.
- ECOG performance status of 0 to 2.
- Life expectancy of at least 3 months.
- Adequate baseline organ function and laboratory values.
- Women of childbearing potential must have a negative pregnancy test within 7 days before treatment.
- Female subjects of childbearing potential and male subjects with partners of childbearing potential must agree to use effective contraception during the study and for 6 months after the last dose.
You will not qualify if you...
- Known active central nervous system primary tumor or brain metastases.
- History of severe chronic or active infections.
- History of active autoimmune diseases.
- History of symptomatic interstitial lung disease.
- Unresolved toxicities from prior therapies above Grade 1 except certain specified exceptions.
- Severe or uncontrolled cardiovascular conditions requiring treatment.
- Prior bone marrow or solid organ transplantation.
- Additional progressing malignancies requiring active treatment within the past 3 years.
- Clinically significant immunosuppression.
- Uncontrolled pleural, pericardial effusion, or ascites requiring repeated drainage.
- Prior treatments targeting B7-H6 or recent anticancer therapies within specified washout periods.
- Participation in other clinical studies with investigational products within 28 days.
- Recent use of immunomodulatory drugs or live vaccines within specified periods.
- Recent major surgery within 4 weeks before treatment.
- Need for anticoagulant treatment that cannot be safely interrupted.
- Known psychiatric or substance abuse disorders interfering with study compliance.
- Pregnancy or breastfeeding.
- Hypersensitivity to study drug components.
- Other serious medical conditions that may interfere with study participation or safety.
- Inability or unwillingness to comply with study procedures or restrictions.
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 - Until treatment discontinuation
Participants receive TGI-6 by intravenous injection as monotherapy. Treatment continues until discontinuation based on tolerability, safety, or disease progression.
Visits occur as per dosing schedule and safety monitoring requirements
Duration - Up to approximately 3 years
After treatment ends, participants are followed for safety and survival outcomes.
Periodic visits for safety and survival follow-up
Trial Site Locations
Total: 1 location
1
Beijing Cancer Hospital
Beijing, China
Actively Recruiting
Research Team
X
Xiaohu Zheng, Doctorate
H
Hang Zhou, Bachelor
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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