Clinical trial · Interventional
TTX-030 in Combination With Immunotherapy and/or Chemotherapy in Subjects With Advanced Cancers
Phase 1/1b Study to Evaluate the Safety and Activity of TTX-030 (Anti-CD39) in Combination With Pembrolizumab or Budigalimab and/or Chemotherapy in Subjects With Advanced Solid Tumors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a phase 1/1b study of TTX-030 in combination therapy, an antibody that inhibits CD39 enzymatic activity, leading to accumulation of pro-inflammatory adenosine triphosphate (ATP) and reduction of immunosuppressive adenosine, which may change the tumor microenvironment and promote anti-tumor immune response. This trial will study the safety, tolerability, pharmacokinetics, pharmacodynamics and anti-tumor activity of TTX-030 in combination with immunotherapy and/or standard chemotherapies.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Solid Tumor, Adult | Adult Solid Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (8)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Budigalimab and mFOLFOX6 | Combination Product | — | UNRESOLVED |
| TTX-030 and budigalimab | Combination Product | — | UNRESOLVED |
| TTX-030 and mFOLFOX6 | Combination Product | — | UNRESOLVED |
| TTX-030 and pembrolizumab | Combination Product | — | UNRESOLVED |
| TTX-030, budigalimab and docetaxel | Combination Product | — | UNRESOLVED |
| TTX-030, budigalimab and mFOLFOX6 | Combination Product | — | UNRESOLVED |
| TTX-030, budigalimab, nab-paclitaxel and gemcitabine | Combination Product | — | UNRESOLVED |
| TTX-030, nab-paclitaxel and gemcitabine | Combination Product |
Design
Arms and outcomes
Arms (8)
- type
- EXPERIMENTAL
- label
- Combo 1
- description
- TTX-030 plus budigalimab plus mFOLFOX6
- interventionNames
- Combination Product: TTX-030, budigalimab and mFOLFOX6
- type
- EXPERIMENTAL
- label
- Combo 2
- description
- TTX-030 plus budigalimab plus docetaxel
- interventionNames
- Combination Product: TTX-030, budigalimab and docetaxel
- type
- EXPERIMENTAL
- label
- Combo 3
- description
- TTX-030 plus mFOLFOX6
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 110 Years
Show eligibility criteria text
Abbreviated Inclusion Criteria: 1. Age 18 years or older, is willing and able to provide informed consent 2. Histologically confirmed diagnosis of unresectable or metastatic solid tumor malignancy in selected tumor types 3. Life expectancy \> 12 weeks 4. ECOG performance status of 0-1 Abbreviated Exclusion Criteria: 1. History of allergy or hypersensitivity to study treatment components. Patients with a history of severe hypersensitivity reaction to any monoclonal antibody. 2. Use of investigational agent within 28 days prior to the first dose of study treatment and throughout the study 3. Receiving high-dose systemic steroid therapy or any other form of immunosuppressive therapy 4. History of severe autoimmune disease 5. Uncontrolled intercurrent illness or other active malignancy requiring ongoing treatment
References
Publications (0)
Data not yet available