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

Phase 1

Active, not recruiting

• Conditions: Cancer; Tumor, Solid; Metastatic Cancer; Nonsmall Cell Lung Cancer; Triple Negative Breast Cancer; Advanced Solid Tumor; Malignant Neoplasm
• Interventions: Drug: HMBD-002; Drug: Pembrolizumab

• Registration Number: NCT05082610
• Lead Sponsor: Hummingbird Bioscience

Brief 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.

Study Timeline

• Study First Submitted: 2021-09-21
• Study First Submitted QC: 2021-10-14
• Study First Posted: 2021-10-19
• Study Start: 2022-02-28
• Primary Completion: 2024-11-05
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-17
• Last Update Posted: 2025-04-18
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 313

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Part 2 - Dose Expansion (Combination Therapy)	HMBD-002	HMBD-002 administered at the MTD/RP2D as a 60-minute IV infusion in combination with pembrolizumab KEYTRUDA® at the standard labeled dose in patients with TNBC or NSCLC.
Part 1 - Dose Escalation Phase (Monotherapy)	HMBD-002	HMBD-002 administered as a 60-minute IV infusion as a monotherapy. HMBD-002 will be administered on Days 1, 8, and 15 of a 21-day cycle.
Part 1 - Dose Escalation Phase (Combination Therapy)	HMBD-002	HMBD-002 administered as a 60-minute IV infusion at escalating doses in combination with pembrolizumab KEYTRUDA®. HMBD-002 will be administered on Days 1, 8, and 15 of a 21-day cycle. The treatment pembrolizumab KEYTRUDA® will be administered as a 30-minute IV infusion at a dose of 200 mg on Day 1 of every 21-day cycle.
Part 1 - Dose Escalation Phase (Combination Therapy)	Pembrolizumab	HMBD-002 administered as a 60-minute IV infusion at escalating doses in combination with pembrolizumab KEYTRUDA®. HMBD-002 will be administered on Days 1, 8, and 15 of a 21-day cycle. The treatment pembrolizumab KEYTRUDA® will be administered as a 30-minute IV infusion at a dose of 200 mg on Day 1 of every 21-day cycle.
Part 2 - Dose Expansion (Monotherapy)	HMBD-002	HMBD-002 administered at the MTD/RP2D as a 60-minute IV infusion as a monotherapy in patients with TNBC or NSCLC.
Part 2 - Dose Expansion (Combination Therapy)	Pembrolizumab	HMBD-002 administered at the MTD/RP2D as a 60-minute IV infusion in combination with pembrolizumab KEYTRUDA® at the standard labeled dose in patients with TNBC or NSCLC.

Primary Outcome Measures

Name	Time	Method
Dose-limiting Toxicity	First 21 days of treatment.	The incidence of DLTs during the DLT assessment period.
Frequency and Severity of Adverse Events (AE)	Screening to 90 days from last dose.	The incidences and percentages of patients experiencing AEs summarized by NCI CTCAE version 5.0 grade and by causality.
Dose-Finding	Screening to 90 days from last dose.	Determination of the MTD or maximum tested dose, and the RP2D.

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics of HMBD-002	Day 1 of dosing through 21 days post last dose.	Area Under the Curve (AUC)
Progression Free Survival (PFS)	Day 1 of dosing through every 90 after the last dose.	Time from the date of initiation of study therapy to the date measurement criteria are first met for PD or death from any cause, whichever occurs first.
Duration of Response (DoR)	Day 1 of dosing through every 90 after the last dose.	Time from the date measurement criteria are first met for PR or CR to the date measurement criteria are first met for PD.
Overall Survival (OS)	Day 1 of dosing through every 90 after the last dose.	Time from the date of initiation of study therapy to the date of death from any cause.
Objective Response Rate (ORR)	Day 1 of dosing through every 90 after the last dose.	ORR according to RECIST v1.1.

Trial Locations

Locations (6)

The City of Hope National Medical Center; 🇺🇸 Duarte, California, United States

Cedars-Sinai Medical Center; 🇺🇸 Los Angeles, California, United States

Stanford Cancer Institute; 🇺🇸 Palo Alto, California, United States

Smilow Cancer Hospital - Yale New Heaven Health; 🇺🇸 New Haven, Connecticut, United States

UTSW Medical Center; 🇺🇸 Dallas, Texas, United States

The University of Texas MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States