Neoplasms

Symptoms and General Pathology

All Conditions

Neoplasm Metastasis

Neoplastic Processes

Antineoplastic Agents

All Drugs and Chemicals

Pembrolizumab

Antibodies

Antibodies, Monoclonal

Immunoglobulins

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

NTX-1088 administered as a 60-minute IV infusion at escalating doses as a monotherapy. NTX-1088 will be administered on Day 1 of a 21-day cycle.

NTX-1088 administered as a 60-minute IV infusion in escalating doses in combination with pembrolizumab. NTX-1088 will be administered on Day 1 of a 21-day cycle.

Pembrolizumab will be administered as a 30-minute IV infusion, within 2 hours prior to NTX-1088 administration, at a dose of 200 mg on Day 1 of every 21-day cycle.

NTX-1088 administered at the RP2D as a 60-minute IV infusion as a monotherapy.

NTX-1088 administered at the RP2D as a 60-minute IV infusion in combination with pembrolizumab at the standard labeled dose.

IgG4 mAb targeting the poliovirus receptor (PVR, CD155).

NTX-1088

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).

Keren Paz, PhD

Miguel Villalona-Calero, MD

Marc Matrana, MD

Sarina A Piha-Paul, MD

Jonathan Cohen, MD/PhD

Shirly Grynberg, MD

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).

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.

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

The incidence of DLTs during the DLT assessment period.

Determination of the MTD or maximum tested dose, and the RP2D.

The incidences and percentages of patients experiencing AEs summarized by NCI CTCAE version 5.0 grade and by causality.

Time from the date measurement criteria are first met for PR or CR to the date measurement criteria are first met for progressive disease.

Time from the date of initiation of study therapy to the date measurement criteria are first met for progressive disease or death from any cause, whichever occurs first.

Time from the date of initiation of study therapy to the date of death from any cause.

Merck Sharp & Dohme LLC

Nectin Therapeutics Ltd

Antibodies, Bispecific

Immunologic Factors

ABL501 will be administered biweekly of every 28-day cycle in the dose-escalation.

ABL501 will be administered biweekly of every 28-day cycle in the dose-escalation. The dosing interval to be used in the dose-expansion part will be re-evaluated based on the emerging safety and PK data from the dose-escalation part of the study.

ABL501

Sangmi Lee

Jooyeon Park

DoYoun Oh

SunYoung Rha

Daeho Lee

Myeongju Ahn

This is a first-in-human (FIH) phase 1 open-label, multicenter, multiple-dose, dose-escalation and dose-expansion study of ABL501 to evaluate the safety, tolerability, MTD and/or RP2D, PK, immunogenicity, preliminary anti-tumor activity, and the PD effect of ABL501 in subjects with any progressive locally advanced (unresectable) or metastatic solid tumors. This study included 2 parts; a dose-escalation part and a dose expansion part.

This is consisted with dose-escalation and dose-expansion study of ABL501 to evaluate the safety, tolerability, MTD and/or RP2D, PK, immunogenicity, anti-tumor activity, and the PD effect of ABL501 in subjects with any progressive locally advanced (unresectable) or metastatic solid tumors.

Study to Evaluate the Safety and Tolerability of ABL501, and to Determine the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of ABL501 in Subjects With Any Progressive, Locally Advanced (Unresectable) or Metastatic Solid Tumors

A Phase 1 Dose Escalation and Expansion Study of ABL501, a Bispecific Antibody of PD-L1 and LAG-3 as a Single Agent in Subjects With Any Progressive, Locally Advanced (Unresectable) or Metastatic Solid Tumors

Number of subject with dose-limiting toxicities (DLT)

Number of subjects who experience with Treatment-emergent adverse events (TEAEs), Serious adverse events (SAEs), immune-related adverse events (irAEs) and infusion related reactions (IRRs)

Number of subjects who experience with treatment-related Treatment-emergent adverse events (TEAEs), Serious adverse events (SAEs), immune-related adverse events (irAEs) and infusion related reactions (IRRs)

Number of subjects who experience with clinically significant changes in laboratory values

serum concentration of ABL501 will be collected and analyzed to evaluate the PK of ABL501

Proportion of subjects with best overall response of complete response (CR) or partial response (PR) per RECIST v1.1

Incidence of anti-drug antibodies (ADAs) will be analyzed to evaluate the immunogenicity of ABL501

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study of NTX-1088, a Monoclonal Antibody Targeting the Poliovirus Receptor (PVR, CD155), as Monotherapy and Combined With Pembrolizumab	NCT05378425	Cancer Tumor, Solid Advanced Solid ... Metastatic Canc... Locally Advance...	NTX-1088 Pembrolizumab	18 Years -	Nectin Therapeutics Ltd
A Study of NTX-1088, a Monoclonal Antibody Targeting the Poliovirus Receptor (PVR, CD155), as Monotherapy and Combined With Pembrolizumab	NCT05378425	Cancer Tumor, Solid Advanced Solid ... Metastatic Canc... Locally Advance...	NTX-1088 Pembrolizumab	18 Years -	Nectin Therapeutics Ltd
Study to Evaluate the Safety and Tolerability of ABL501, and to Determine the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of ABL501 in Subjects With Any Progressive, Locally Advanced (Unresectable) or Metastatic Solid Tumors	NCT05101109	Advanced Solid ...	ABL501	18 Years -	ABL Bio, Inc.

Spots Global Cancer Trial Database for immune oncology