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TGI-6

Phase 1

Advanced or Metastatic Solid Tumors | Small molecule | Oncology |TG Therapeutics, Inc.|Last Updated: Apr 18, 2024

Success Probability
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Market & Valuation
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Trial Design
UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment123
FDA Designations
No designations recorded
Clinical trial landscape

TGI-6 · 1 trial · 1 indication

Phase 1 1
NCT06374173A Phase 1 Study to Evaluate TGI-6 in Subjects With Locally Advanced/Metastatic Solid TumorsAdvanced or Metastatic Solid Tumors
RECRUITING123 Analytics
PHASE1RECRUITING
A Phase 1 Study to Evaluate TGI-6 in Subjects With Locally Advanced/Metastatic Solid Tumors
Advanced or Metastatic Solid Tumors
NCT06374173123
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Study Endpoints
Primary Endpoints
Dose-limiting Toxicity (DLT)
First 21 days of treatment.

The incidence of DLTs during the DLT assessment period.

Dose-Finding
Approximately 3 years.

Determination of the MTD or maximum tested dose, and the RP2D.

Frequency and Severity of Adverse Events (AE)
Screening to 30 days from last dose

The incidences and percentages of patients experiencing AEs summarized by NCI CTCAE version 5.0 grade and by causality.

Secondary Endpoints
Pharmacokinetics of TGI-6
Day 1 of dosing through 7 days post last dose
Number of subjects with Anti-TGI-6 antibody positive
Day 1 of dosing through 7 days post last dose
Objective Response Rate (ORR)
Approximately 3 years.
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
TGI-6 InjectionEXPERIMENTALTGI-6 monotherapy dose escalation(Phase 1a) . TGI-6 monotherapy dose expansion(Phase 1b) .
Interventions
NameTypeDescription
TGI-6 InjectionDRUGTGI-6 will be administered intravenously at a dose and schedule as specified for the respective study part and cohort.
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Eligibility Criteria
Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Male or female subjects age ≥18 years at the time of informed consent. 2. Phase 1a: Subjects with histologically or cytologically diagnosed unresectable locally advanced/metastatic CRC. Or subjects with confirmed B7-H6-positive unresectable locally advanced/metastatic solid t...

Countries:China
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Competitive Landscape -Other Solid Tumors 9 trials (matched to "Advanced or Metastatic Solid Tumors")
CompanyTickerTrialsLead PhaseDrugs
Merck & Co., Inc.MRK2PHASE2pembrolizumab
Incyte CorporationINCY1PHASE2Chemotherapy, Retifanlimab
Iovance Biotherapeutics IncIOVA2PHASE2E7 TCR-T cells, Aldesleukin
Novartis AG Sponsored ADRNVS1PHASE1KFA115, pembrolizumab
AstraZeneca PLCAZN1 - Trastuzumab deruxtecan
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT06374173primaryCompletionDate: changed
LOWMay 24, 2026NCT06374173studyFirstPostDate: changed