CancerPhase 1NCT05082610
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 testing HMBD-002 and Pembrolizumab in people with Cancer and Tumor, Solid, run by Hummingbird Bioscience at 6 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Tumor, Solid, Nonsmall Cell Lung Cancer
- What is being tested?
- HMBD-002 and Pembrolizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 6 sitesUnited States
- Study dates
- 28 Feb 2022to 3 Dec 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologic or cytologic evidence of a malignant solid cancer (any histology) with advanced or metastatic disease and no available therapies known to confer clinical benefit.
- Tumor tissue, or paraffin block, ideally from the patient's most recent biopsy. A fresh tumor biopsy will be obtained if archival samples are not available.
- Measurable by Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1.
- At least 18 years old.
- An Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1.
- Adequate hematopoietic, kidney, and liver functions.
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- A left ventricular ejection fraction (LVEF) ≥ 45%.
- Women of childbearing potential (WOCBP) must not be pregnant or breastfeeding. A WOCBP must agree to follow contraceptive guidance during the treatment period and for at least 120 days after the last dose of study treatment.
- Male subjects must agree to follow contraceptive guidance during the study period and for at least 120 days after the last dose of study treatment.
- Patient must give informed written consent for the study.
- Triple Negative Breast Cancer (TNBC)
- Histologic or cytologic evidence of TNBC that is advanced or metastatic.
- Will be requested to undergo a tumor biopsy before treatment and after 6 weeks of treatment.
- Must have received appropriate treatment with at least one prior regimen for TNBC and there are no available therapies known to confer clinical benefit.
- Non-Small Cell Lung Cancer (Monotherapy and Combination)
- Histologic or cytologic evidence of NSCLC that is advanced or metastatic.
- Will be requested to undergo a tumor biopsy before treatment and after 6 weeks of treatment.
- Absence of an activating mutation of the EGFR or ALK.
- Must have received treatment with an approved therapy if there are other genomic aberrations for which targeted therapies are approved and available.
- Must have had disease progression on at least one approved or comparable standard therapy for NSCLC.
- Must have received appropriate prior treatment with a mAb to PD-1 or PD-L1.
- Multiple Other Cancers (Combination Therapy Baskets)
- Histologic or cytologic evidence of an advanced or metastatic cancer aside from TNBC and NSCLC with no available therapies known to confer clinical benefit.
- Will be requested to undergo a tumor biopsy before treatment and after 6 weeks of treatment.
- Must have had appropriate treatment for their specific cancer and there is an absence of available therapy with a reasonable likelihood of conferring clinical benefit.
Who cannot join
- If the patient received prior therapy with an anti-PD-1 or anti-PD-L1 mAb or with an agent targeting stimulatory or co-inhibitory T-cell receptor and was discontinued from that treatment due to a Grade 3 or higher immune related adverse event.
- Received radiotherapy within 2 weeks of treatment.
- Received radiotherapy exceeding 30 Gray (Gy) to the lung within 6 months of the first dose of study medication.
- Received an allogeneic tissue/solid organ transplant.
- Received a live or live-attenuated vaccine within 30 days prior to the first dose of study medication.
- Received a VISTA targeting agent.
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- The patient must have recovered from all AEs due to previous therapies to ≤Grade 1 or baseline.
- The patient has an active autoimmune disease that required systemic treatment in the past.
- Presence of an uncontrolled endocrine disorder.
- Presence of clinically significant cardiovascular disease.
- History of (non-infectious) pneumonitis or interstitial pulmonary disease that required steroids or has current pneumonitis or interstitial pulmonary disease.
- Presence of uncontrolled, clinically significant pulmonary disease.
- A previous a severe hypersensitivity reaction (≥ Grade 3) to pembrolizumab and/or any of its excipients.
- A diagnosis of immunodeficiency or is receiving chronic systemic corticosteroids at a dose that exceeds 10 mg daily of prednisone equivalent or any other form of immunosuppressive therapy within 7 days prior the first dose of study drug. Inhaled or topical steroids are permitted in the absence of active autoimmune disease.
- An uncontrolled intercurrent illness that would limit compliance with the study.
- A positive status for human immunodeficiency virus (HIV).
- A known history of Hepatitis B (defined as HBsAg reactive) or known active Hepatitis C viral (defined as HCV RNA detected) infection.
- Oxygen-dependence.
- A medical condition which, in the opinion of the Investigator, places the patient at an unacceptably high risk for toxicity.
- A positive COVID test within one week of study treatment if not fully vaccinated.
- Another active malignancy that is progressing or has required active treatment within the past 3 years.
- Known active central nervous system metastases and/or carcinomatous meningitis.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
UTSW Medical Center
Dallas, Texas, 75390
The City of Hope National Medical Center
Duarte, California, 91010
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Smilow Cancer Hospital - Yale New Heaven Health
New Haven, Connecticut, 06511
Stanford Cancer Institute
Palo Alto, California, 94304
About this study
Official title: 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
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).
Read the 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
- Being tested
- HMBD-002, Pembrolizumab
- Medical subject headings
- Neoplasms, Carcinoma, Non-Small-Cell Lung, Triple Negative Breast Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HMBD-002Drug
IgG4 monoclonal antibody (mAb) targeting the V-domain immunoglobulin suppressor of T cell activation (VISTA) receptor.
PembrolizumabDrug
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).
| Study group | Role | What they receive |
|---|---|---|
| Part 1 - Dose Escalation Phase (Monotherapy) | Experimental | 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. Receives: Drug: HMBD-002 |
| Part 1 - Dose Escalation Phase (Combination Therapy) | Experimental | 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. Receives: Drug: HMBD-002; Drug: Pembrolizumab |
| Part 2 - Dose Expansion (Monotherapy) | Experimental | HMBD-002 administered at the MTD/RP2D as a 60-minute IV infusion as a monotherapy in patients with TNBC or NSCLC. Receives: Drug: HMBD-002 |
| Part 2 - Dose Expansion (Combination Therapy) | Experimental | 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. Receives: Drug: HMBD-002; Drug: Pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting Toxicity
The incidence of DLTs during the DLT assessment period.
Measured: First 21 days of treatment.
Dose-Finding
Determination of the MTD or maximum tested dose, and the RP2D.
Measured: Screening to 90 days from last dose.
Frequency and Severity of Adverse Events (AE)
The incidences and percentages of patients experiencing AEs summarized by NCI CTCAE version 5.0 grade and by causality.
Measured: Screening to 90 days from last dose.
Secondary outcomes (6)
Pharmacokinetics of HMBD-002
Maximum Plasma Concentration (Cmax)
Measured: Day 1 of dosing through 21 days post last dose.
Pharmacokinetics of HMBD-002
Area Under the Curve (AUC)
Measured: Day 1 of dosing through 21 days post last dose.
Objective Response Rate (ORR)
ORR according to RECIST v1.1.
Measured: Day 1 of dosing through every 90 after the last dose.
Duration of Response (DoR)
Time from the date measurement criteria are first met for PR or CR to the date measurement criteria are first met for PD.
Measured: Day 1 of dosing through every 90 after the last dose.
Progression Free Survival (PFS)
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.
Measured: Day 1 of dosing through every 90 after the last dose.
Overall Survival (OS)
Time from the date of initiation of study therapy to the date of death from any cause.
Measured: Day 1 of dosing through every 90 after the last dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2021
- Study start28 Feb 2022
- Primary completion5 Nov 2024
- Study completion3 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hummingbird Bioscience
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05082610
- Sponsor's protocol ID
- HMBD-002-V4C26-01
- Status last verified
- Apr 2025
- First submitted
- 21 Sep 2021
- Last updated
- 16 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05082610
- Acronym / sponsor ID
- HMBD-002-V4C26-01
- Conditions
- Cancer, Tumor, Solid, Nonsmall Cell Lung Cancer, Triple Negative Breast Cancer, Malignant Neoplasm, Metastatic Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Hummingbird BioscienceIndustry (pharma, biotech, devices)
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 28 Feb 2022 (actual)
- Primary completion
- 5 Nov 2024 (actual)
- Study completion
- 3 Dec 2024 (actual)
- First posted
- 19 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Part 1 - Dose Escalation Phase (Monotherapy) | Experimental | Drug: HMBD-002HMBD-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) | Experimental | Drug: HMBD-002, Drug: PembrolizumabHMBD-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) | Experimental | Drug: HMBD-002HMBD-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) | Experimental | Drug: HMBD-002, Drug: PembrolizumabHMBD-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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (25 listed)
- Histologic or cytologic evidence of a malignant solid cancer (any histology) with advanced or metastatic disease and no available therapies known to confer clinical benefit.
- Tumor tissue, or paraffin block, ideally from the patient's most recent biopsy. A fresh tumor biopsy will be obtained if archival samples are not available.
- Measurable by Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1.
- At least 18 years old.
- An Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1.
Key exclusion criteria (22 listed)
- If the patient received prior therapy with an anti-PD-1 or anti-PD-L1 mAb or with an agent targeting stimulatory or co-inhibitory T-cell receptor and was discontinued from that treatment due to a Grade 3 or higher immune related adverse event.
- Received radiotherapy within 2 weeks of treatment.
- Received radiotherapy exceeding 30 Gray (Gy) to the lung within 6 months of the first dose of study medication.
- Received an allogeneic tissue/solid organ transplant.
- Received a live or live-attenuated vaccine within 30 days prior to the first dose of study medication.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HMBD-002IgG4 monoclonal antibody (mAb) targeting the V-domain immunoglobulin suppressor of T cell activation (VISTA) receptor. | Drug | Part 1 - Dose Escalation Phase (Combination Therapy), Part 1 - Dose Escalation Phase (Monotherapy), Part 2 - Dose Expansion (Combination Therapy), Part 2 - Dose Expansion (Monotherapy) |
| PembrolizumabIgG4 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). | Drug | Part 1 - Dose Escalation Phase (Combination Therapy), Part 2 - Dose Expansion (Combination Therapy) |
Primary outcome
Dose-limiting Toxicity
Time frame: First 21 days of treatment.
The incidence of DLTs during the DLT assessment period.
Dose-Finding
Time frame: Screening to 90 days from last dose.
Determination of the MTD or maximum tested dose, and the RP2D.
Frequency and Severity of Adverse Events (AE)
Time frame: 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.
6 secondary outcomes
Pharmacokinetics of HMBD-002
Time frame: Day 1 of dosing through 21 days post last dose.
Pharmacokinetics of HMBD-002
Time frame: Day 1 of dosing through 21 days post last dose.
Objective Response Rate (ORR)
Time frame: Day 1 of dosing through every 90 after the last dose.
Duration of Response (DoR)
Time frame: Day 1 of dosing through every 90 after the last dose.
Progression Free Survival (PFS)
Time frame: Day 1 of dosing through every 90 after the last dose.
Overall Survival (OS)
Time frame: Day 1 of dosing through every 90 after the last dose.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HMBD-002 and Pembrolizumab in people with Cancer and Tumor, Solid, run by Hummingbird Bioscience at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 25 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-limiting Toxicity (time frame: First 21 days of treatment.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2025.