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Monoclonal Antibodies

HMBD-002 + Pembrolizumab for Cancer

Phase 1
Recruiting
Research Sponsored by Hummingbird Bioscience, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
At least 18 years old
Must not have
A positive status for human immunodeficiency virus (HIV)
Presence of uncontrolled, clinically significant pulmonary disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 of dosing through every 90 after the last dose.
Awards & highlights

Summary

This trial is testing a new drug, HMBD-002, on patients with advanced solid tumors. The drug will be administered intravenously, and the trial will have two parts: dose escalation and dose expansion.

Who is the study for?
Adults with advanced solid tumors, including specific types of breast and lung cancer without available beneficial therapies. Participants must have measurable disease, be at least 18 years old with good performance status and organ function, agree to contraception, and provide informed consent. Excludes those with certain infections or immune conditions, recent high-dose radiotherapy to the lungs, severe treatment-related adverse events from similar drugs, uncontrolled diseases or other active cancers.
What is being tested?
The trial is testing HMBD-002 alone or combined with Pembrolizumab in patients with various advanced solid tumors. It's a two-part study: first finding the right dose (dose escalation) then expanding that dose to more patients (dose expansion). The treatments are given intravenously on different schedules.
What are the potential side effects?
Potential side effects include reactions related to the immune system such as inflammation in organs; infusion-related reactions; fatigue; changes in blood counts which can affect overall health; increased risk of infections due to weakened immunity.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have advanced or metastatic TNBC and have tried at least one treatment with no success.
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I am 18 years old or older.
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My cancer is advanced or has spread, and there are no treatments left that could help.
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I can carry out all my usual activities without help.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am HIV positive.
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I have a serious lung condition that is not under control.
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I had radiotherapy less than 2 weeks ago.
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I have not received a live vaccine in the last 30 days.
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I have had lung inflammation or disease that needed steroids.
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I stopped a cancer treatment due to a severe immune reaction.
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I have been treated with a VISTA targeting agent.
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I am not on high-dose steroids or other drugs that weaken my immune system.
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I have not had any other cancer that is getting worse or needed treatment in the last 3 years.
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I have cancer that has spread to my brain or spinal cord.
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I have a hormone disorder that is not under control.
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I have a history of Hepatitis B or active Hepatitis C.
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I have received a transplant from another person.
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I have had radiation to my lung of more than 30 Gray in the last 6 months.
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I need oxygen support to breathe.
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I do not have any other illnesses that would stop me from following the study's requirements.
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I have a serious heart condition.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 of dosing through every 90 after the last dose.
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 of dosing through every 90 after the last dose. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Dose-Finding
Dose-limiting Toxicity
Frequency and Severity of Adverse Events (AE)
Secondary study objectives
Duration of Response (DoR)
Objective Response Rate (ORR)
Overall Survival (OS)
+2 more

Side effects data

From 2022 Phase 1 & 2 trial • 35 Patients • NCT03003468
40%
FATIGUE
37%
INFUSION RELATED REACTION
37%
NAUSEA
23%
DIARRHEA
23%
BACK PAIN
23%
ABDOMINAL PAIN
23%
ANOREXIA
20%
ARTHRALGIA
20%
COUGH
20%
NON-CARDIAC CHEST PAIN
17%
DYSPNEA
17%
CONSTIPATION
17%
CHILLS
17%
MYALGIA
13%
DIZZINESS
13%
HEADACHE
13%
PRURITUS
13%
RASH MACULO-PAPULAR
10%
ANEMIA
10%
URTICARIA
10%
SINUS TACHYCARDIA
10%
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS - OTHER, SPECIFY
10%
EDEMA LIMBS
10%
ALLERGIC REACTION
10%
ANXIETY
10%
LUNG INFECTION
10%
SKIN AND SUBCUTANEOUS TISSUE DISORDERS - OTHER, SPECIFY
7%
TUMOR PAIN
7%
EAR AND LABYRINTH DISORDERS - OTHER, SPECIFY
7%
HYPERGLYCEMIA
7%
PAIN
7%
PELVIC PAIN
7%
PRODUCTIVE COUGH
7%
PLEURAL EFFUSION
7%
VOICE ALTERATION
7%
VOMITING
7%
FEVER
7%
FLATULENCE
7%
CREATININE INCREASED
7%
HYPERTHYROIDISM
7%
NECK PAIN
7%
DEPRESSION
7%
FLU LIKE SYMPTOMS
7%
LYMPHOCYTE COUNT DECREASED
7%
DYSPEPSIA
7%
FLUSHING
7%
HYPONATREMIA
7%
HYPOTHYROIDISM
7%
URINARY TRACT INFECTION
3%
MUSCLE WEAKNESS LOWER LIMB
3%
ALKALINE PHOSPHATASE INCREASED
3%
DYSPHAGIA
3%
ESOPHAGITIS
3%
GASTROESOPHAGEAL REFLUX DISEASE
3%
OSTEONECROSIS OF JAW
3%
BRONCHOSPASM
3%
PNEUMONITIS
3%
SORE THROAT
3%
BLURRED VISION
3%
GAIT DISTURBANCE
3%
HEMORRHOIDS
3%
POSTNASAL DRIP
3%
PRESYNCOPE
3%
ACUTE KIDNEY INJURY
3%
PERIPHERAL MOTOR NEUROPATHY
3%
DRY SKIN
3%
FLASHING LIGHTS
3%
HYPOMAGNESEMIA
3%
HYPERTENSION
3%
HYPOTENSION
3%
SINUSITIS
3%
SYNCOPE
3%
HEARING IMPAIRED
3%
RASH ACNEIFORM
3%
SOMNOLENCE
3%
COLITIS
3%
HOT FLASHES
3%
RESPIRATORY FAILURE
3%
CONJUNCTIVITIS
3%
MOVEMENTS INVOLUNTARY
3%
NASAL CONGESTION
3%
PARESTHESIA
3%
VAGINAL INFECTION
3%
GASTROINTESTINAL DISORDERS - OTHER, SPECIFY
3%
NEUTROPHIL COUNT DECREASED
3%
ALLERGIC RHINITIS
3%
PAIN IN EXTREMITY
3%
SEPSIS
3%
BLOATING
3%
DEHYDRATION
3%
DRY MOUTH
3%
INSOMNIA
3%
MALAISE
3%
PAIN OF SKIN
3%
THROMBOEMBOLIC EVENT
3%
TREMOR
3%
WEIGHT GAIN
100%
80%
60%
40%
20%
0%
Study treatment Arm
Imprime PGG 4 mg/kg
Imprime PGG 2 mg/kg

Trial Design

4Treatment groups
Experimental Treatment
Group I: Part 2 - Dose Expansion (Monotherapy)Experimental Treatment1 Intervention
HMBD-002 administered at the MTD/RP2D as a 60-minute IV infusion as a monotherapy in patients with TNBC or NSCLC.
Group II: Part 2 - Dose Expansion (Combination Therapy)Experimental Treatment2 Interventions
HMBD-002 administered at the MTD/RP2D as a 60-minute IV infusion in combination with pembrolizumab at the standard labeled dose in patients with TNBC or NSCLC.
Group III: Part 1 - Dose Escalation Phase (Monotherapy)Experimental Treatment1 Intervention
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.
Group IV: Part 1 - Dose Escalation Phase (Combination Therapy)Experimental Treatment2 Interventions
HMBD-002 administered as a 60-minute IV infusion at escalating doses in combination with pembrolizumab. HMBD-002 will be administered on Days 1, 8, and 15 of a 21-day cycle. Pembrolizumab will be administered as a 30-minute IV infusion at a dose of 200 mg on Day 1 of every 21-day cycle.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2070

Find a Location

Who is running the clinical trial?

Hummingbird Bioscience, Inc.Lead Sponsor
Merck Sharp & Dohme LLCIndustry Sponsor
3,950 Previous Clinical Trials
5,174,743 Total Patients Enrolled
Hummingbird BioscienceLead Sponsor
3 Previous Clinical Trials
265 Total Patients Enrolled

Media Library

HMBD-002 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05082610 — Phase 1
Cancer Research Study Groups: Part 2 - Dose Expansion (Combination Therapy), Part 1 - Dose Escalation Phase (Monotherapy), Part 1 - Dose Escalation Phase (Combination Therapy), Part 2 - Dose Expansion (Monotherapy)
Cancer Clinical Trial 2023: HMBD-002 Highlights & Side Effects. Trial Name: NCT05082610 — Phase 1
HMBD-002 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05082610 — Phase 1
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