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Histone Methyltransferase Inhibitor
Bomedemstat + Immunotherapy for Small Cell Lung Cancer
Phase 1 & 2
Waitlist Available
Led By Renato Martins
Research Sponsored by University of Washington
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Able to swallow capsules
Eastern Cooperative Oncology Group (ECOG) performance status of =< 2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from the date of registration until death from any cause, assessed at 6 months
Awards & highlights
Study Summary
This trial is testing a new drug combo for patients with small cell lung cancer.
Who is the study for?
Adults over 18 with newly diagnosed extensive stage small cell lung cancer (ES-SCLC) who've completed initial chemoimmunotherapy and are eligible for maintenance atezolizumab. They must have a life expectancy of at least 12 weeks, adequate organ function, no prior ES-SCLC systemic therapy other than specified treatments, and not be pregnant or breastfeeding. Participants should agree to contraception use and not have certain autoimmune diseases or hypersensitivities.Check my eligibility
What is being tested?
The trial is testing bomedemstat in combination with the immunotherapy drug atezolizumab to see if they're more effective for treating ES-SCLC. Bomedemstat may halt tumor growth by inhibiting enzymes needed for cell proliferation while atezolizumab could boost the immune system's ability to fight cancer.See study design
What are the potential side effects?
Possible side effects include reactions related to immune system activation such as inflammation in various organs, fatigue, blood disorders like anemia or clotting issues, potential digestive problems, increased risk of infections due to immune modulation, and specific drug-related sensitivities.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can swallow pills.
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I can take care of myself but might not be able to do heavy physical work.
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My lung cancer is confirmed to be extensive stage small-cell type.
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I've had 4 cycles of platinum-etoposide and 3-4 cycles of immune therapy for small cell lung cancer.
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My blood clotting time is within normal range and I'm not on blood thinners.
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I agree to use birth control during and for 28 days after the study treatment.
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My kidney function, measured by GFR, is adequate.
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I am able to get out of my bed or chair and move around.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from the date of registration to the date of first document of progressive disease or symptomatic deterioration (as defined above), or death due to any cause, assessed at 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from the date of registration to the date of first document of progressive disease or symptomatic deterioration (as defined above), or death due to any cause, assessed at 6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of adverse events
Incidence of dose limiting toxicity (DLT)
Progression free survival
Secondary outcome measures
Overall survival
Side effects data
From 2022 Phase 1 & 2 trial • 90 Patients • NCT0313618588%
Thrombocytopenia
63%
Nausea
50%
Oedema peripheral
38%
Pneumonia
38%
Diarrhoea
38%
Dysgeusia
25%
Pyrexia
25%
Pollakiuria
25%
Hot flush
25%
Fatigue
25%
Anaemia
25%
Constipation
25%
COVID-19
25%
Vomiting
25%
Hypoalbuminaemia
25%
Decreased appetite
25%
Muscular weakness
25%
Pain in extremity
25%
Myalgia
25%
Chronic obstructive pulmonary disease
25%
Epistaxis
25%
Hypotension
25%
Tachycardia
13%
Dry mouth
13%
Conjunctivitis
13%
Contusion
13%
Upper respiratory tract infection
13%
Cardiac murmur
13%
Hyperuricaemia
13%
Nephrolithiasis
13%
Pruritus
13%
Rash
13%
Small intestinal haemorrhage
13%
Rectal haemorrhage
13%
Influenza
13%
Neutropenia
13%
Septic shock
13%
Headache
13%
Dyspnoea
13%
Respiratory failure
13%
Ocular hyperaemia
13%
Bradycardia
13%
Lymphopenia
13%
Abdominal distension
13%
Abdominal pain
13%
Oral pain
13%
Erysipelas
13%
Fall
13%
Skin infection
13%
Blood alkaline phosphatase increased
13%
Activated partial thromboplastin time prolonged
13%
Parkinson's disease
13%
Blood lactate dehydrogenase increased
13%
Blood uric acid increased
13%
Blood sodium decreased
13%
Blood calcium decreased
13%
Blood potassium decreased
13%
Increased appetite
13%
Blood glucose increased
13%
Hypokalaemia
13%
Prothrombin time prolonged
13%
Hypophosphataemia
13%
Blood phosphorus decreased
13%
Weight decreased
13%
Paraesthesia
13%
Genital rash
13%
Muscle spasms
13%
Musculoskeletal pain
13%
Hypoxia
13%
Cough
13%
Rhinorrhoea
13%
Rash maculo-papular
13%
Decubitus ulcer
13%
Nail dystrophy
13%
Hypertension
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ph 2b PMF: Bomedemstat 0.5 mg/kg/d
Ph 1/2a PMF: Bomedemstat 0.25 mg/kg/d
Ph 2b PET-MF: Bomedemstat 0.6 mg/kg/d
Ph 1/2a PPV-MF: Bomedemstat 0.25 mg/kg/d
Ph 1/2a PET-MF: Bomedemstat 0.25 mg/kg/d
Ph 2b PET-MF: Bomedemstat 0.5 mg/kg/d
Ph 2b PPV-MF: Bomedemstat 0.5 mg/kg/d
Ph 2b PMF: Bomedemstat 0.6 mg/kg/d
Ph 2b PPV-MF: Bomedemstat 0.6 mg/kg/d
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (bomedemstat, atezolizumab)Experimental Treatment2 Interventions
Patients receive bomedemstat PO QD on days 1-21 and atezolizumab IV on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bomedemstat
2017
Completed Phase 2
~170
Atezolizumab
2017
Completed Phase 3
~5860
Find a Location
Who is running the clinical trial?
Imago BioSciences,Inc.Industry Sponsor
9 Previous Clinical Trials
410 Total Patients Enrolled
Imago BioSciences, Inc., a subsidiary of Merck & Co., Inc., (Rahway, New Jersey USA)Industry Sponsor
9 Previous Clinical Trials
410 Total Patients Enrolled
University of WashingtonLead Sponsor
1,744 Previous Clinical Trials
1,848,343 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are allergic to PD-1/PD-L1 targeting drugs.I do not have any ongoing infections that aren't responding to treatment.I can swallow pills.I recently started treatment with specific drugs for small cell lung cancer.I have not received a live vaccine in the last 30 days.I am allergic to bomedemstat, LSD1 inhibitors, or similar drugs.I had small cell lung cancer treatment and it came back after finishing treatment.My blood clotting time is within the normal range and I'm not on blood thinners.Your hemoglobin level is at least 8.0 grams per deciliter.I haven't used myeloid growth factors in the last 14 days.My cancer hasn't worsened after initial treatment with specific drugs.My cancer hasn't worsened after initial treatment with specific drugs.I had major surgery less than 4 weeks ago or am still dealing with its side effects.Your platelet count is at least 75,000 per microliter of blood without needing a transfusion.I have only had four cycles of specific chemotherapy and immunotherapy for my small cell lung cancer.I have small cell lung cancer that hasn't been treated yet.I am 18 or older and can sign a consent form.I agree to use two birth control methods or not have sex during and for 28 days after the study.I've had radiation after starting treatment with platinum-etoposide and an immune checkpoint inhibitor.I am okay with giving blood samples for the study.You are expected to live for at least 12 more weeks.I can take care of myself but might not be able to do heavy physical work.My lung cancer is confirmed to be extensive stage small-cell type.Your blood bilirubin level is not too high, unless you have Gilbert's disease, in which case it can be a little higher.I have or had lung inflammation that needed treatment with strong medication.I have an autoimmune disease and have been on systemic immunosuppressants.I've had 4 cycles of platinum-etoposide and 3-4 cycles of immune therapy for small cell lung cancer.I am currently taking MAOI medications.I haven't taken immunosuppressive drugs in the last 14 days.I am not pregnant, breastfeeding, nor planning to become pregnant or breastfeed during the study.I've had severe side effects from immune therapy that make further treatment unsafe.I cannot stop taking my blood thinner or anti-inflammatory medication even if my platelet count is low.I am not taking any medication that is not allowed in this study.I have a bleeding disorder or a history of very low platelet counts.I expect to undergo brain or chest radiation therapy during the study.I have no GI issues that could affect medication absorption or increase my study risk.I have another cancer that my doctor thinks is important.I have HIV or active hepatitis B/C.I haven't used myeloid growth factors in the last 14 days.My blood clotting time is within normal range and I'm not on blood thinners.I agree to use birth control during and for 28 days after the study treatment.My small cell lung cancer progressed after initial treatment.My kidney function, measured by GFR, is adequate.My liver enzymes are within the acceptable range for the trial.I am able to get out of my bed or chair and move around.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (bomedemstat, atezolizumab)
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.
Is this clinical trial a pioneering endeavor?
"To date, Baxter Healthcare Corporation has conducted 104 clinical trials for Bomedemstat in 1650 cities located within 74 nations. The first trial commenced in 2007 with 4640 participants and concluded its Phase 4 drug approval stage. Currently there are 365 active studies centred around this pharmaceutical product."
Answered by AI
Is this research currently accepting new participants?
"Affirmative. Clinicaltrials.gov data indicates that this medical trial, which was initially listed on April 11th 2022, is currently in the process of recruiting patients. In total, 34 individuals are required across 1 clinical site for successful completion of the study."
Answered by AI
How many participants are being recruited into this experiment?
"Affirmative! The information on clinicaltrials.gov highlights the fact that this medical trial is actively pursuing participants. This research was first made public on April 11th 2022 and has been recently updated as of June 22nd 2022. 34 patients are needed to be enrolled from one location."
Answered by AI
Have any previous investigations made use of Bomedemstat?
"Presently, there are 365 clinical trials active for Bomedemstat; 71 of those have progressed to Phase 3. While the bulk of these experiments are situated in Basel, BS, a total of 18418 sites worldwide are conducting research on this medication."
Answered by AI
For what reasons is Bomedemstat often prescribed?
"Bomedemstat can be used therapeutically to reduce weight gain. It has also been successfully employed by medical professionals in the treatment of small cell lung cancer (sclc), malignant neoplasms, and amino acid supplementation."
Answered by AI
Who else is applying?
What state do they live in?
Washington
South Carolina
What portion of applicants met pre-screening criteria?
Met criteria
What site did they apply to?
Fred Hutch/University of Washington Cancer Consortium
How many prior treatments have patients received?
1
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