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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 of dosing through every 90 after the last dose.
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I have advanced or metastatic TNBC and have tried at least one treatment with no success.
Select...
I am 18 years old or older.
Select...
My cancer is advanced or has spread, and there are no treatments left that could help.
Select...
I can carry out all my usual activities without help.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 1 of dosing through every 90 after the last dose.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 of dosing through every 90 after the last dose.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Dose-Finding
Dose-limiting Toxicity
Frequency and Severity of Adverse Events (AE)
Secondary outcome measures
Duration of Response (DoR)
Objective Response Rate (ORR)
Overall Survival (OS)
+2 moreSide effects data
From 2024 Phase 2 trial • 57 Patients • NCT0300418321%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Pneumonia
7%
Kidney Injury and/or Infection
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Intractable pain, back pain, hip pain
5%
Activated partial thromboplastin time prolonged
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Thrombocytopenia
2%
Respiratory failure
2%
Skin rash
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm
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
~2010
Find a Location
Who is running the clinical trial?
Hummingbird Bioscience, Inc.Lead Sponsor
Merck Sharp & Dohme LLCIndustry Sponsor
3,888 Previous Clinical Trials
5,054,764 Total Patients Enrolled
Hummingbird BioscienceLead Sponsor
3 Previous Clinical Trials
265 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am HIV positive.I have a serious lung condition that is not under control.I had radiotherapy less than 2 weeks ago.I agree to follow birth control advice for 4 months after my last treatment.My blood, kidney, and liver functions are all within normal ranges.I tested positive for COVID within a week of the study treatment and am not fully vaccinated.I can provide a recent biopsy sample or a new one will be taken.I have not received a live vaccine in the last 30 days.I have had lung inflammation or disease that needed steroids.I stopped a cancer treatment due to a severe immune reaction.I have been treated with a VISTA targeting agent.You have a condition where your immune system attacks your own body and needed medication for it in the past.I am not pregnant or breastfeeding and agree to use contraception as advised.I have recovered from side effects of previous treatments to my normal or mild condition.I am not on high-dose steroids or other drugs that weaken my immune system.I have not had any other cancer that is getting worse or needed treatment in the last 3 years.I have advanced or metastatic TNBC and have tried at least one treatment with no success.I have advanced NSCLC without EGFR or ALK mutations and have progressed after treatment.I have cancer that has spread to my brain or spinal cord.I have an advanced cancer other than TNBC or NSCLC and no treatments left that could help.I am 18 years old or older.My cancer is advanced or has spread, and there are no treatments left that could help.I have a hormone disorder that is not under control.I have a history of Hepatitis B or active Hepatitis C.I have received a transplant from another person.I have had radiation to my lung of more than 30 Gray in the last 6 months.Your heart's pumping ability is good, with a left ventricular ejection fraction (LVEF) of 45% or higher.I can carry out all my usual activities without help.Your tumor can be measured using specific guidelines called RECIST version 1.1.I need oxygen support to breathe.I do not have any other illnesses that would stop me from following the study's requirements.Your doctor thinks you have a medical condition that could make the treatment too risky for you.I have a serious heart condition.You had a very bad allergic reaction to pembrolizumab or any of its ingredients before.
Research Study Groups:
This trial has the following groups:- Group 1: Part 2 - Dose Expansion (Combination Therapy)
- Group 2: Part 1 - Dose Escalation Phase (Monotherapy)
- Group 3: Part 1 - Dose Escalation Phase (Combination Therapy)
- Group 4: Part 2 - Dose Expansion (Monotherapy)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are the primary aims of this exploration?
"This clinical trial will assess the Dose-limiting Toxicity of the medication in question over a period ranging from screening to 90 days post last dose. Secondary outcomes include Duration of Response, Objective Response Rate and Overall Survival."
Answered by AI
What can the public expect in terms of safety from HMBD-002?
"Since HMBD-002 is currently in its first phase of clinical trials, there is limited data on the safety and efficacy - for this reason our team at Power assigned a score of 1."
Answered by AI
Can you elucidate the primary ailments that HMBD-002 is intended to address?
"HMBD-002 can be used to successfully tackle malignancies, unresectable melanomas, and microsatellite instability high cases."
Answered by AI
Is this medical research open to recruitment at present?
"Affirmative. According to clinicaltrials.gov, this experiment is currently searching for participants who meet the criteria and have consented. The trial was posted on January 1st 2022 has been updated as recently as June 8th 20202 and aims to recruit 240 patients from 6 sites across the country."
Answered by AI
How many participants does this research endeavor include?
"In order to initiate the trial, Hummingbird Bioscience, Inc. needs 240 eligible participants. This study will be conducted in various locations such as Stanford Cancer Institute and Dan L Duncan Comprehensive Cancer Center."
Answered by AI
To what extent has HMBD-002 been explored through previous clinical trials?
"The original HMBD-002 research was conducted in 2010 at City of Hope. As of today, there have been 251 studies completed while 961 are actively enrolling participants; a significant portion hailing from Palo Alto, California."
Answered by AI
In how many locales can this clinical experiment be accessed?
"This medical research is currently happening at 6 clinic sites, including those in Palo Alto, Houston and Dallas. To reduce commuting time associated with enrolling, it's best to choose a location nearest you."
Answered by AI
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