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NCT03884556 · ClinicalTrials.gov registry record · Phase 1
TTX-030 Single Agent and in Combination With Immunotherapy or Chemotherapy for Patients With Advanced Cancers
A Phase 1 study, sponsored by Trishula Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 56
- Enrollment target
NCT03884556: Completed Phase 1 study, sponsored by Trishula Therapeutics.
NCT03884556 is a Phase 1 study that has completed, run by Trishula Therapeutics. The registered enrollment target is 56 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03884556, a Phase 1 study, has completed, sponsored by Trishula Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 56 participants
- Enrollment target
Study 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.
Primary Outcome
A DLT was defined as any clinically significant AE that occurred during Treatment Cycle 1 that the Investigator or Sponsor considered as possibly or likely related to TTX-030 as a single agent, or the combination of TTX-030 and other agent(s), and met the following criteria: NCI CTCAE Version 5.0 Grade 5 event, Grade 4 hematological or Grade≥3 non-hematological toxicities, or Grade≥3 irAEs. Laboratory abnormalities that were asymptomatic and deemed not clinically significant were not regarded as
Interventions
- DRUG Pembrolizumab
- DRUG Gemcitabine
- DRUG nab paclitaxel
- DRUG TTX-030
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 56 participants |
| Start Date | 2019-04-10 |
| Est. Completion | 2023-09-29 |
| Phase | Phase 1 |
What the finished NCT03884556 record still lists
NCT03884556 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 56 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 4 interventions - of which Pembrolizumab is the first listed.
NCT03884556 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03884556 about?
NCT03884556 is a clinical study titled "TTX-030 Single Agent and in Combination With Immunotherapy or Chemotherapy for Patients With Advanced Cancers". 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 t...
What is the current status of trial NCT03884556?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 56 participants. The study started on 2019-04-10. Estimated completion is 2023-09-29.
What interventions are being tested in trial NCT03884556?
The interventions under investigation include: Pembrolizumab (DRUG), Gemcitabine (DRUG), nab paclitaxel (DRUG), TTX-030 (DRUG).
Who is sponsoring clinical trial NCT03884556?
This trial is sponsored by Trishula Therapeutics, which has 3 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03884556's enrollment target sits among peer trials
56 902nd of 2000 higher than 1,083 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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