Trials / Recruiting
RecruitingNCT05378425
A Study of NTX-1088, a Monoclonal Antibody Targeting the Poliovirus Receptor (PVR, CD155), as Monotherapy and Combined With Pembrolizumab
A Phase 1, First-in-Human Study of NTX-1088, a Monoclonal Antibody Targeting the Poliovirus Receptor (PVR, CD155), as Monotherapy and Combined With Pembrolizumab, in Patients With Advanced Solid Malignancies
- Status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 90 (estimated)
- Sponsor
- Nectin Therapeutics Ltd · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a Phase 1,open-label, multi-center, first-in-human, 2-part (Part 1: dose escalation and Part 2: expansion) study, evaluating multiple doses and schedules of intravenously (IV) administered NTX-1088, with or without pembrolizumab, in patients with advanced solid malignancies (i.e., locally advanced or metastatic).
Detailed description
This is a Phase 1, open-label, multi-center study whose principal Part 1 stage objective is to determine the recommended Phase 2 dose (RP2D) of the anti-PVR monoclonal antibody (mAb) as a single agent and combined with the anti-PD-1 mAb pembrolizumab in patients with advanced solid malignancies. In the Part 2 stage, the antitumor activity of NTX-1088 alone or combined with pembrolizumab will be evaluated in patients with malignancies known to express PVR.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | NTX-1088 | IgG4 mAb targeting the poliovirus receptor (PVR, CD155). |
| DRUG | Pembrolizumab | IgG4 mAb with high specificity of binding to the PD-1 receptor, thus inhibiting its interaction with programmed cell death ligand 1 (PD-L1) and programmed cell death ligand 2 (PD-L2). |
Timeline
- Start date
- 2022-09-01
- Primary completion
- 2025-12-01
- Completion
- 2026-12-01
- First posted
- 2022-05-18
- Last updated
- 2025-09-09
Locations
6 sites across 3 countries: United States, Israel, Poland
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05378425. Inclusion in this directory is not an endorsement.