Actively Recruiting
A Phase 1 Study to Evaluate TGI-6 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
204 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
A Phase 1 Study to Evaluate TGI-6 in Subjects with Locally Advanced/Metastatic Solid Tumors
CONDITIONS
Official 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 age years at the time of informed consent
- Phase 1a: Subjects with confirmed unresectable locally advanced or metastatic colorectal cancer (CRC) or B7-H6-positive locally advanced/metastatic solid tumors
- Phase 1b Cohort 1: Subjects with confirmed unresectable locally advanced or metastatic CRC
- Phase 1b Cohort 2: Subjects with confirmed unresectable locally advanced/metastatic B7-H6-positive solid tumors
- Subjects in Phase 1a or Phase 1b Cohort 2 must have progressed despite or be intolerant to all standard therapies or have no standard therapy available
- All subjects except CRC patients must agree to tumor sample collection for B7-H6 testing
- Subjects must have at least one evaluable (Phase 1a) or measurable (Phase 1b) lesion per RECIST v1.1
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 2
- Life expectancy of at least 3 months
- Adequate baseline organ function and laboratory results
- Women of childbearing potential must have a negative pregnancy test within 7 days before treatment
- Female subjects of childbearing potential or male subjects with partners of childbearing potential must agree to use effective contraception during the study and for 6 months after last dose
You will not qualify if you...
- Active central nervous system primary tumor or 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 controlled conditions
- Severe or uncontrolled cardiovascular disorders needing treatment
- Prior bone marrow or solid organ transplantation
- Other progressing malignancies requiring treatment within past 3 years
- Clinically significant immunosuppression
- Uncontrolled pleural, pericardial effusion, or ascites needing recurrent drainage
- Previous treatment with B7-H6-targeting therapy
- Recent chemotherapy, targeted therapy, immunotherapy, or anticancer herbal therapy within specified washout periods
- Prior radiotherapy within 4 weeks except single fraction for palliation
- Participation in other clinical trials with investigational products within 28 days
- Use of systemic immunomodulatory drugs within 14 days
- Receipt of live vaccines within 4 weeks
- Major surgery within 4 weeks or planned during study
- Anticoagulant treatment that cannot be safely interrupted
- Psychiatric or substance abuse disorders interfering with study compliance
- Pregnancy or breastfeeding
- Known hypersensitivity to study drug components
- Other serious medical conditions or diseases that may interfere with study or increase risk
- Inability or unwillingness to comply with study procedures or restrictions
AI-Screening
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Trial Site Locations
Total: 1 location
1
Beijing Cancer Hospital
Beijing, China
Actively Recruiting
Research Team
X
Xiaohu Zheng, Doctorate
CONTACT
H
Hang Zhou, Bachelor
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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