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NCT05277402 · ClinicalTrials.gov registry record · Phase 1
ADG116 in Combination With Pembrolizumab in Patients With Advanced/Metastatic Solid Tumors
A Phase 1 study, sponsored by Adagene.
- Completed
- Registry status
- Phase 1
- Development phase
- 6
- Enrollment target
NCT05277402: Completed Phase 1 study, sponsored by Adagene.
NCT05277402 is a Phase 1 study that has completed, run by Adagene. The registered enrollment target is 6 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05277402, a Phase 1 study, has completed, sponsored by Adagene.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 6 participants
- Enrollment target
Study Summary
This is a Phase 1b, open-label, dose escalation study to evaluate the safety, tolerability, PK, and immunogenicity of an ADG116-pembrolizumab combination regimen in patients with advanced/metastatic solid tumors. Study drug ADG116, is an anti -CTLA-4 fully human monoclonal antibody that specifically binds to human CTLA-4. Pembrolizumab is a PD-1 receptor-blocking antibody (a humanized IgG4 monoclonal antibody) which is indicated for the treatment of patients across a number of indications. The treatment strategy of using anti-PD 1 therapy combined with anti-CTLA-4 therapy is to explore the potential of combination checkpoint inhibition regimens for the enhanced antitumor efficacy results.
Primary Outcome
Number of participants experiencing dose-limiting toxicities escalating dose levels in adults with advanced / metastatic solid tumor
Interventions
- DRUG ADG116
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2022-02-09 |
| Est. Completion | 2022-12-01 |
| Phase | Phase 1 |
What the finished NCT05277402 record still lists
NCT05277402 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 1 intervention - of which ADG116 is the first listed.
NCT05277402 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05277402 about?
NCT05277402 is a clinical study titled "ADG116 in Combination With Pembrolizumab in Patients With Advanced/Metastatic Solid Tumors". This is a Phase 1b, open-label, dose escalation study to evaluate the safety, tolerability, PK, and immunogenicity of an ADG116-pembrolizumab combination regimen in patients with advanced/metastatic solid tumors. Study drug ADG116, is an anti -CTLA-4 fully human monoclonal antibody that specifically...
What is the current status of trial NCT05277402?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 6 participants. The study started on 2022-02-09. Estimated completion is 2022-12-01.
What interventions are being tested in trial NCT05277402?
The interventions under investigation include: ADG116 (DRUG).
Who is sponsoring clinical trial NCT05277402?
This trial is sponsored by Adagene, which has 6 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05277402's enrollment target sits among peer trials
6 1974th of 2000 higher than 12 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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