Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT05043714 · ClinicalTrials.gov registry record · Phase 1
Study of NG-641 in Combination With Nivolumab in Metastatic or Advanced Epithelial Tumours
A Phase 1 study, sponsored by Akamis Bio.
- Completed
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
NCT05043714: Completed Phase 1 study, sponsored by Akamis Bio.
NCT05043714 is a Phase 1 study that has completed, run by Akamis Bio. The registered enrollment target is 30 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05043714, a Phase 1 study, has completed, sponsored by Akamis Bio.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
Study Summary
This is a phase 1a/1b, multicentre, open-label, non-randomized study of NG-641 in combination with nivolumab (or standard of care PD-1 inhibition) in patients with metastatic or advanced epithelial tumours. The purpose is to characterize the safety and tolerability of NG-641 in combination with nivolumab in patients with metastatic or advanced epithelial tumours and to determine the recommended dose of NG-641 in combination with nivolumab for further development in patients with metastatic or advanced epithelial tumours
Primary Outcome
Incidence of: adverse events (AEs), serious adverse events (SAEs), AEs leading to discontinuation of study treatment or study discontinuation and AEs resulting in death and Incidence of AEs meeting protocol defined dose-limiting toxicity (DLT) criteria
Interventions
- BIOLOGICAL NG-641 in combination with Nivolumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2021-12-01 |
| Est. Completion | 2024-10-04 |
| Phase | Phase 1 |
What the finished NCT05043714 record still lists
NCT05043714 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower).
The record links to 0 conditions, and to 1 intervention - of which NG-641 in combination with Nivolumab is the first listed.
NCT05043714 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05043714 about?
NCT05043714 is a clinical study titled "Study of NG-641 in Combination With Nivolumab in Metastatic or Advanced Epithelial Tumours". This is a phase 1a/1b, multicentre, open-label, non-randomized study of NG-641 in combination with nivolumab (or standard of care PD-1 inhibition) in patients with metastatic or advanced epithelial tumours. The purpose is to characterize the safety and tolerability of NG-641 in combination with niv...
What is the current status of trial NCT05043714?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2021-12-01. Estimated completion is 2024-10-04.
What interventions are being tested in trial NCT05043714?
The interventions under investigation include: NG-641 in combination with Nivolumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT05043714?
This trial is sponsored by Akamis Bio, which has 6 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05043714's enrollment target sits among peer trials
30 1332nd of 2000 higher than 561 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00977977 · 30 participants · Phase 2
Rituximab Plus Cyclosporine in Idiopathic Membranous Nephropathy
- NCT01459107 · 30 participants · Phase 2
Human Upper Extremity Allotransplantation
- NCT01666080 · 30 participants · NA
Second or Greater Allogeneic Hematopoietic Stem Cell Transplant Using Reduced Intensity Conditioning (RIC)
- NCT01720836 · 30 participants · Phase 1
Study of the Immune Response of MUC1 (Mucin1) Peptide Vaccine for Non-small Cell Lung Cancer
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI