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New treatment option for Advanced or Metastatic Solid Tumors
Official title A Phase 1 Study to Evaluate TGI-6 in Subjects With Locally Advanced/Metastatic Solid Tumors
ClinicalTrials.gov ID: NCT06374173
What this study is testing
What is TGI-6 Injection?
TGI-6 Injection is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for advanced or metastatic solid tumors.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- A Phase 1 Study to Evaluate TGI-6 in Subjects with Locally Advanced/Metastatic Solid Tumors
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Male or female people age ≥18 years at the time of informed consent.
- Phase 1a: people with histologically or cytologically diagnosed unresectable locally advanced/metastatic CRC. Or people with confirmed B7-H6-positive...
- Phase 1a or Phase1b Cohort 2: people should have progressed despite all standard therapy or be intolerant of all standard therapy, or for whom no...
- All people except people with CRC must agree to the collection of tumor samples for confirmation of B7-H6 expression status in a central lab.
- people in Phase 1a must have at least one evaluable lesion as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. people in Phase...
You likely can't join if
- Subject with known active central nervous system (CNS) primary tumor or metastases.
- History of intercurrent severe chronic or active infections.
- Has a history of active autoimmune diseases .
- Has a history of symptomatic interstitial lung disease.
- Toxicities of prior therapies have not been resolved to Grade ≤1 or baseline as per NCI-CTCAE v5.0, except for alopecia, skin hyperpigmentation...
- people with severe or uncontrolled cardiovascular disorder requiring treatment.
See the full eligibility criteria
- Male or female people age ≥18 years at the time of informed consent.
- Phase 1a: people with histologically or cytologically diagnosed unresectable locally advanced/metastatic CRC. Or people with confirmed B7-H6-positive unresectable locally advanced/metastatic solid tumors, mainly but not...
- Phase 1a or Phase1b Cohort 2: people should have progressed despite all standard therapy or be intolerant of all standard therapy, or for whom no standard therapy exists. (Standard therapies are defined as treatments...
- All people except people with CRC must agree to the collection of tumor samples for confirmation of B7-H6 expression status in a central lab.
- people in Phase 1a must have at least one evaluable lesion as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. people in Phase 1b must have least one measurable lesion as defined per RECIST v1.1...
- ECOG PS (Appendix 5) of 0\~2.
- Life expectancy ≥3 months.
- people have sufficient baseline organ function and laboratory data .
- Woman of childbearing potential must have a negative serum pregnancy test within 7 days prior to treatment.
- Female people of childbearing potential or male people with a partner of childbearing potential must agree to use effective contraception at the time of informed consent and continuing through the study until 6 months...
- Subject with known active central nervous system (CNS) primary tumor or metastases.
- History of intercurrent severe chronic or active infections.
- Has a history of active autoimmune diseases .
- Has a history of symptomatic interstitial lung disease.
- Toxicities of prior therapies have not been resolved to Grade ≤1 or baseline as per NCI-CTCAE v5.0, except for alopecia, skin hyperpigmentation, Grade 2 neuropathy and Grade 2 endocrinopathy that is well controlled by...
- people with severe or uncontrolled cardiovascular disorder requiring treatment.
- Prior allogenic or autologous bone marrow transplantation or other solid organ transplantation.
- Has a known additional malignancy that is progressing or has required active treatment within the past 3 years .
- Evidence of clinically significant immunosuppression .
- Presence of uncontrolled pleural effusion, pericardial effusion or ascites requiring recurrent drainage procedures .
- Previously treated with the following anti-tumor therapy (prior to the first dose of TGI-6): 1) Previous treated with any B7-H6-targeting therapy. 2) Chemotherapy, target therapy, immunotherapy, or other anticancer...
- Washout period for nitrosoureas or mitomycin is ≤6 weeks.
- ≤5 half-lives or 2 weeks (whichever is longer) for fluoropyrimidines or small-molecule targeted agents.
- Washout period for herbal therapy with anticancer indications is ≤2 weeks. 3) Prior radiotherapy ≤4 weeks prior to the first dose of study treatment, with the exception of a single fraction of radiotherapy for the...
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.