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NCT04799054 · ClinicalTrials.gov registry record · Phase 1
A Study of TransCon TLR7/8 Agonist With or Without Pembrolizumab in Patients With Advanced or Metastatic Solid Tumors
A Phase 1 study, sponsored by Ascendis Pharma Oncology Division A/S.
- Terminated
- Registry status
- Phase 1
- Development phase
- 188
- Enrollment target
NCT04799054: Clinical Trial Phase 1 study, sponsored by Ascendis Pharma Oncology Division A/S.
NCT04799054 is a Phase 1 study that was terminated before completion, run by Ascendis Pharma Oncology Division A/S. The registered enrollment target is 188 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (213% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04799054, a Phase 1 study, was terminated before completion, sponsored by Ascendis Pharma Oncology Division A/S.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 188 participants
- Enrollment target
Study Summary
TransCon TLR7/8 Agonist is an investigational drug being developed for treatment of locally advanced or metastatic solid tumors. This Phase 1/2 study will evaluate TransCon TLR7/8 Agonist as monotherapy or in combination with pembrolizumab in dose escalation and dose expansion. Participants will receive intratumoral (IT) injection of TransCon TLR7/8 Agonist every cycle. The primary objectives are to evaluate safety and tolerability, and define the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of TransCon TLR7/8 Agonist alone or in combination with pembrolizumab.
Primary Outcome
Treatment emergent and treatment related adverse events (assessed by CTCAE v5.0), serious adverse events (SAEs), adverse events leading to treatment discontinuation, deaths
Interventions
- DRUG Pembrolizumab
- DRUG TransCon TLR7/8 Agonist
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 188 participants |
| Start Date | 2021-03-18 |
| Est. Completion | 2025-12-02 |
| Phase | Phase 1 |
Why NCT04799054 stopped before completion
NCT04799054 is an interventional study that assigns participants to a tested intervention. The registered 188 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (213% higher).
The record links to 0 conditions, and to 2 interventions - of which Pembrolizumab is the first listed.
NCT04799054 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04799054 about?
NCT04799054 is a clinical study titled "A Study of TransCon TLR7/8 Agonist With or Without Pembrolizumab in Patients With Advanced or Metastatic Solid Tumors". TransCon TLR7/8 Agonist is an investigational drug being developed for treatment of locally advanced or metastatic solid tumors. This Phase 1/2 study will evaluate TransCon TLR7/8 Agonist as monotherapy or in combination with pembrolizumab in dose escalation and dose expansion. Participants will rec...
What is the current status of trial NCT04799054?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 188 participants. The study started on 2021-03-18. Estimated completion is 2025-12-02.
What interventions are being tested in trial NCT04799054?
The interventions under investigation include: Pembrolizumab (DRUG), TransCon TLR7/8 Agonist (DRUG).
Who is sponsoring clinical trial NCT04799054?
This trial is sponsored by Ascendis Pharma Oncology Division A/S, which has 2 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04799054's enrollment target sits among peer trials
188 289th of 2000 higher than 1,711 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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