Phase 1
Completed N=185
TTX-030 in Combination With Immunotherapy and/or Chemotherapy in Subjects With Advanced Cancers
Solid Tumor, Adult
Source: ClinicalTrials.gov NCT04306900 ↗
Enrolled (actual)
185
Serious AEs
51.9%
Results posted
Jul 2025
Primary outcomePrimary: Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs) — 6; 0; 0; 0 Participants
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs) |
6; 0; 0; 0; 7; 0 | — |
| PRIMARY The Incident of Adverse Events |
8; 44; 25; 6; 7; 28 | — |
| SECONDARY Confirmed Objective Response Rate (ORR) |
14.3; 56.1; 69.6; 75.0; 0; 33.3 | — |
| SECONDARY Best Response (BOR) |
0; 5; 2; 0; 0; 0 | — |
| SECONDARY Duration of Response (DOR) |
13; 4; 3; 4; 4; 1 | — |
| SECONDARY Disease Control Rate (DCR) |
3; 37; 22; 3; 2; 22 | — |
| SECONDARY Progression-free Survival (PFS) |
5; 27; 9; 4; 3; 14 | — |
| SECONDARY Overall Survival (OS) |
0; 0; 3; 0; 0; 1 | — |
| SECONDARY Pharmacokinetics (PK) |
503; 449; 814; 511; 458; 601 | — |
Eligibility Criteria
Abbreviated Inclusion Criteria:
- Age 18 years or older, is willing and able to provide informed consent
- Histologically confirmed diagnosis of unresectable or metastatic solid tumor malignancy in selected tumor types
- Life expectancy > 12 weeks
- ECOG performance status of 0-1
Abbreviated Exclusion Criteria:
- History of allergy or hypersensitivity to study treatment components. Patients with a history of severe hypersensitivity reaction to any monoclonal antibody.
- Use of investigational agent within 28 days prior to the first dose of study treatment and throughout the study
- Receiving high-dose systemic steroid therapy or any other form of immunosuppressive therapy
- History of severe autoimmune disease
- Uncontrolled intercurrent illness or other active malignancy requiring ongoing treatment
Data sourced from ClinicalTrials.gov (NCT04306900). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.