NCT05082610

A Study of HMBD-002, a Monoclonal Antibody Targeting VISTA, as Monotherapy and Combined With Pembrolizumab, in Patients With Advanced Solid Tumors

A Phase 1 Study of HMBD-002-V4C26 (HMBD-002), a Monoclonal Antibody Targeting VISTA, as Monotherapy and Combined With Pembrolizumab, in Patients With Advanced Solid Malignancies

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Hummingbird Bioscience · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a phase 1/2, open-label, multi-center, first-in-human, two-stage (Part 1: dose escalation and Part 2: dose expansion) study evaluating multiple doses and schedules of intravenously (IV) administered HMBD-002, with or without pembrolizumab KEYTRUDA®, in patients with advanced solid tumors (i.e., locally advanced and unresectable, or metastatic).

Detailed description

This is a phase 1/2, open-label, multi-center study whose principal phase 1 stage objective is to determine the recommended phase 2 dose (RP2D) of the anti-VISTA monoclonal antibody (mAb) as a single agent and combined with the anti-PD-1 mAb pembrolizumab KEYTRUDA® in subjects with advanced solid malignancies. In the phase 2 stage, the antitumor activity of HMBD-002 alone or combined with pembrolizumab KEYTRUDA® will be evaluated in patients with triple negative breast cancer (TNBC), non-small cell lung cancer (NSCLC) and a wide range of other malignancies known or documented to express VISTA.

Conditions

• Cancer
• Tumor, Solid
• Nonsmall Cell Lung Cancer
• Triple Negative Breast Cancer
• Malignant Neoplasm
• Metastatic Cancer
• Advanced Solid Tumor

Interventions

Type	Name	Description
DRUG	HMBD-002	IgG4 monoclonal antibody (mAb) targeting the V-domain immunoglobulin suppressor of T cell activation (VISTA) receptor.
DRUG	Pembrolizumab	IgG4 mAb with high specificity of binding to the PD-1 receptor, thus inhibiting its interaction with PD-L1 and programmed cell death ligand 2 (PD-L2).

Timeline

• Start date: 2022-02-28
• Primary completion: 2024-11-05
• Completion: 2024-12-03
• First posted: 2021-10-19
• Last updated: 2025-10-16

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated drug study