ADVANCED SOLID TUMORS: PHASE 1: ADENOSINE PATHWAY: TTX-030-002

Phase 1/1b Study to Evaluate the Safety and Activity of TTX-030 (Anti-CD39) in Combination With Budigalimab and/or Chemotherapy in Subjects With Advanced Solid Tumors

Title
Tizona TTX-030-002 (TTX-030 + budigalimab)
Study Title

Phase 1/1b Study to Evaluate the Safety and Activity of TTX-030 (Anti-CD39) in Combination With Budigalimab and/or Chemotherapy in Subjects With Advanced Solid Tumors

Site Link
Malignancy
Prostate, Kidney, Head and Neck, Colon Rectum, Gastric, Esophagus
Stage
Disease Setting
Metastatic/Palliative
Line Of Therapy
late line
Investigational Agent
TTX-030, budigalimab
Drug Class
Anti CD-39, anti-PD1
PI
Dan Vaena, MD
Sponsor
Tizona Therapeutics
Phase
Status
Key Eligibility Criteria
Key Eligibility Criteria Details
  • Advanced Solid Malignancy
  • Fresh and/or archival tumor tissue
  • Evidence of measurable disease (except for prostate)
  • Life expectancy >12 weeks
  • ECOG PS 0-1
  • No therapeutic anticoagulation
  • no history of autoimmune disease
  • No uncontrolled intercurrent illness
  • No HTN >150/90 despite optimal management
  • No active CNS mets
  • No other malignancies within 3 years
  • No autoimmune toxicity >Grade 3 from prior immunotherapy
Objective
  • Primary
    • Adverse Events
  • Secondary
    • ORR
    • DoR
    • DCR
    • PFS
    • PK
Assessment Frequency
_
Assessment Frequency 2
_



Assessment Frequency Link
Path
Any
Dosing Frequency
Control Agents
Study Protocol
Randomized
No
X