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Histone Methyltransferase Inhibitor

Bomedemstat + Immunotherapy for Small Cell Lung Cancer

Phase 1 & 2
Recruiting
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
International normalized ratio (INR) < 1.5 x upper limit of normal (only in patients not receiving anticoagulant agents at baseline)
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 below
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I can swallow pills.
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My blood clotting time is within the normal range and I'm not on blood thinners.
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My cancer hasn't worsened after initial treatment with specific drugs.
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I am 18 or older and can sign a consent form.
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I agree to use two birth control methods or not have sex during and for 28 days after the study.
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I am okay with giving blood samples for the study.
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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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I haven't used myeloid growth factors in the last 14 days.
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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 small cell lung cancer progressed after initial treatment.
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My kidney function, measured by GFR, is adequate.
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My liver enzymes are within the acceptable range for the trial.
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My lung cancer is confirmed to be extensive stage small-cell type.
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I am able to get out of my bed or chair and move around.

Timeline

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
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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 for reporting.

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 • NCT03136185
55%
Thrombocytopenia
36%
Contusion
27%
Depression
27%
Arthralgia
27%
Oedema peripheral
27%
Hypocalcaemia
27%
Constipation
27%
Back pain
27%
Dysgeusia
27%
Anaemia
27%
Nausea
18%
Pain in extremity
18%
Palpitations
18%
Hyperuricaemia
18%
Fatigue
18%
Urine abnormality
18%
Pruritus
18%
Hypertension
18%
Muscular weakness
18%
Asthenia
18%
Abdominal pain
18%
Fall
18%
Dry mouth
18%
Decreased appetite
18%
Lymphopenia
18%
Activated partial thromboplastin time prolonged
18%
Diarrhoea
18%
Hyponatraemia
18%
Dizziness
18%
Cough
18%
Alopecia
18%
Blood uric acid increased
18%
Insomnia
18%
International normalised ratio increased
18%
Dyspnoea
9%
Blood albumin decreased
9%
Flank pain
9%
Mouth haemorrhage
9%
Blood alkaline phosphatase increased
9%
Traumatic haematoma
9%
Heart rate irregular
9%
Haematoma
9%
Early satiety
9%
Non-cardiac chest pain
9%
Petechiae
9%
Pleural effusion
9%
Stress cardiomyopathy
9%
Pyrexia
9%
Cellulitis
9%
Gout
9%
Musculoskeletal chest pain
9%
Eye oedema
9%
Sepsis
9%
Pneumonitis
9%
Leukopenia
9%
Hypervolaemia
9%
Stomatitis
9%
Balance disorder
9%
Blood creatinine increased
9%
Hypophosphataemia
9%
Hypotension
9%
Sinus tachycardia
9%
Breast pain
9%
Skin ulcer
9%
Catathrenia
9%
Abdominal wall haematoma
9%
Myocardial ischaemia
9%
Abdominal distension
9%
Confusional state
9%
Neck pain
9%
Headache
9%
Vomiting
9%
Pallor
9%
Splenic infarction
9%
Wound secretion
9%
Blood bilirubin increased
9%
Blood thyroid stimulating hormone increased
9%
Cachexia
9%
Pelvic pain
9%
Vulvovaginal pruritus
9%
Hyperhidrosis
9%
Aortic arteriosclerosis
9%
Nail disorder
9%
Dysphagia
9%
Hyperglycaemia
9%
Myalgia
9%
Epistaxis
9%
Rash
9%
Chest pain
9%
Blood magnesium decreased
9%
Calcium ionised decreased
9%
Disturbance in attention
9%
Drooling
9%
Urinary incontinence
9%
Dry skin
9%
Flatulence
9%
Neuralgia
9%
Rash maculo-papular
9%
Abdominal pain upper
9%
Hyperactive pharyngeal reflex
9%
Eczema
9%
Blood lactate dehydrogenase increased
9%
Hypokalaemia
9%
Neutropenia
9%
Bone pain
9%
Lacrimation increased
9%
Anal pruritus
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ph 2b PPV-MF: Bomedemstat 0.6 mg/kg/d
Ph 2b PMF: Bomedemstat 0.5 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 1/2a PMF: Bomedemstat 0.25 mg/kg/d
Ph 1/2a PPV-MF: Bomedemstat 0.25 mg/kg/d
Ph 2b PET-MF: Bomedemstat 0.6 mg/kg/d
Ph 2b PMF: 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
~150
Atezolizumab
2016
Completed Phase 3
~6040

Find a Location

Who is running the clinical trial?

Imago BioSciences,Inc.Industry Sponsor
9 Previous Clinical Trials
397 Total Patients Enrolled
Imago BioSciences, Inc., a subsidiary of Merck & Co., Inc., (Rahway, New Jersey USA)Industry Sponsor
9 Previous Clinical Trials
397 Total Patients Enrolled
University of WashingtonLead Sponsor
1,732 Previous Clinical Trials
1,842,080 Total Patients Enrolled

Media Library

Bomedemstat (Histone Methyltransferase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05191797 — Phase 1 & 2
Small Cell Lung Cancer Research Study Groups: Treatment (bomedemstat, atezolizumab)
Small Cell Lung Cancer Clinical Trial 2023: Bomedemstat Highlights & Side Effects. Trial Name: NCT05191797 — Phase 1 & 2
Bomedemstat (Histone Methyltransferase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05191797 — Phase 1 & 2

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
~9 spots leftby Jan 2025