Phase 1
Completed N=56
TTX-030 Single Agent and in Combination With Immunotherapy or Chemotherapy for Patients With Advanced Cancers
Solid Tumor · Lymphoma
Source: ClinicalTrials.gov NCT03884556 ↗
Enrolled (actual)
56
Serious AEs
35.7%
Results posted
Jul 2025
Primary outcomePrimary: Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs) — 0; 0; 0; 0 Participants
Summary
This is a phase 1/1b study of TTX-030, 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, and anti-tumor activity of TTX-030 as a single agent and in combination with an approved anti-PD-1 immunotherapy and standard chemotherapies.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs) |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Objective Response Rate (ORR) - Arm 1 and Arm 2 Expansion Cohorts |
7; 9.1 | — |
| SECONDARY Objective Response Rate (ORR) (Except for Arm 1 and 2 Expansion Cohorts, Where ORR Was a Primary Endpoint) |
1; 2; 1; 3; 2; 3 | — |
| SECONDARY Maximum Plasma Concentration (Cmax) |
4.91; 25.9; 35.2; 79.3; 188; 190 | — |
Eligibility Criteria
Abreviated Inclusion Criteria
- Advanced solid tumor malignancy or relapsed/refractory lymphoma, or
- eligible to receive single-agent pembrolizumab as standard of care, or
- eligible to receive single-agent docetaxel as standard of care, or
- advanced pancreatic adenocarcinoma and eligible to receive gemcitabine plus nab-paclitaxel as standard of care.
- Age 18 years or older, is willing and able to provide informed consent
- Evidence of measurable disease
- Life expectancy > 12 weeks and Eastern Cooperative Oncology Group (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 (NCT03884556). 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.