Trial results for a Phase 1 study investigating TTX-030 as a single agent and in combination with immunotherapy, including pembrolizumab, for patients with advanced cancers were posted on ClinicalTrials.gov on 2025-07-02. The study reported 0 dose-limiting toxicities across all evaluated doses of TTX-030 as a single agent.
Background
Pembrolizumab (Keytruda) is an anti-PD-1 immunotherapy widely used in oncology. This trial also investigated TTX-030, an antibody designed to inhibit CD39 enzymatic activity. This inhibition is intended to lead to the accumulation of pro-inflammatory adenosine triphosphate (ATP) and a reduction of immunosuppressive adenosine, potentially altering the tumor microenvironment and promoting an anti-tumor immune response. The study focused on patients with Solid Tumor and Lymphoma.
Trial design
The completed Phase 1 study (NCT03884556) enrolled 56 participants with Solid Tumor and Lymphoma. The trial evaluated 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 (such as pembrolizumab) and standard chemotherapies (gemcitabine, nab paclitaxel).
Key results
The trial reported on the number of participants who experienced dose-limiting toxicities (DLTs) and objective response rates (ORR) for TTX-030 as a single agent:
- For dose-limiting toxicities, 0 Participants experienced DLTs across all evaluated single-agent TTX-030 dose levels, including 1.5 mg/kg, 3.0 mg/kg, 6.0 mg/kg, 10 mg/kg, 20 mg/kg, and 40 mg/kg.
- Objective response rates for TTX-030 as a single agent were reported as:
- 1 percentage of participants at 0.5 mg/kg
- 2 percentage of participants at 1.5 mg/kg
- 1 percentage of participants at 3.0 mg/kg
- 3 percentage of participants at 6.0 mg/kg
- 2 percentage of participants at 10 mg/kg
- 3 percentage of participants at 20 mg/kg
What this means
The absence of dose-limiting toxicities across all tested single-agent doses of TTX-030 suggests a favorable safety and tolerability profile for the drug in this Phase 1 study. This early safety data is crucial for the continued development of TTX-030, particularly in combination regimens. While the objective response rates for TTX-030 as a single agent were low, ranging from 1% to 3%, this trial also explored TTX-030 in combination with immunotherapies like pembrolizumab and chemotherapies. The full implications of TTX-030's role in combination therapies will depend on further data from these arms, which were not detailed in the provided key measurements.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT03884556, titled "TTX-030 Single Agent and in Combination With Immunotherapy or Chemotherapy for Patients With Advanced Cancers," were posted on 2025-07-02 on clinicaltrials.gov.