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Topoisomerase I inhibitor
BAY 1895344 + Chemotherapy for Lung Cancer
Saint Peters, MO
Phase 1
Waitlist Available
Led By Satya Das
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients must have a solid tumor for which irinotecan or topotecan is considered standard of care
Glomerular filtration rate (GFR) >= 60 mL/min/1.73 m^2
Must not have
Patients with uncontrolled intercurrent illness
Patients with an uncontrolled infection requiring IV antibiotics
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6 months post-treatment
Awards & highlights
No Placebo-Only Group
Summary
This trial tests the safety and best dose of a new drug combined with chemotherapy in patients with advanced solid tumors. The goal is to see if this combination can slow tumor growth more effectively than chemotherapy alone. The new drug blocks enzymes needed for tumor growth, while the chemotherapy drugs kill or stop the tumor cells from dividing. The chemotherapy drugs used in this trial are known to be effective in treating various cancers.
Who is the study for?
Adults with advanced solid tumors, specifically small cell lung cancer, neuroendocrine carcinoma, or pancreatic cancer that have worsened after standard treatment. Must be able to swallow pills and not have severe heart disease. Eligible even if HIV-positive or with treated hepatitis B/C as long as it's under control. Cannot join if pregnant/breastfeeding or on certain drugs affecting liver enzymes.
What is being tested?
The trial is testing the effectiveness of adding a new anti-cancer drug called BAY 1895344 to usual chemotherapy (irinotecan or topotecan). The goal is to see if this combination can better halt tumor growth compared to standard chemotherapy alone in patients with specific advanced cancers.
What are the potential side effects?
Possible side effects include reactions related to the immune system, fatigue, digestive issues like nausea and diarrhea from chemotherapy, potential liver enzyme changes due to BAY 1895344, and other common chemo-related symptoms such as hair loss.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer treatment includes irinotecan or topotecan.
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My kidney function, measured by GFR, is normal or above 60.
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My cancer has spread, can't be surgically removed, and has worsened after treatment.
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I have at least one tumor that can be measured, not including the one to be biopsied.
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I am 18 years old or older.
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My hepatitis B virus load is undetectable with treatment.
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My brain scans show no worsening after treatment for brain metastases and I have no symptoms.
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I have advanced lung, neuroendocrine, or pancreatic cancer that has worsened after treatment.
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I had hepatitis C but have been treated and cured.
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I can take care of myself but might not be able to do heavy physical work.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not have any unmanaged ongoing illnesses.
Select...
I have an infection that needs IV antibiotics.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 6 months post-treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 6 months post-treatment
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Maximum tolerated dose (MTD) (Dose Escalation Phase)
Occurrence of grade 4 hematologic AEs (Dose Expansion Phase)
Secondary study objectives
Area under the concentration-time curve (AUC)
Changes in tumor expression patterns of gamma-H2AX
Changes in tumor expression patterns of pS343-NBS1
+5 moreOther study objectives
Tumor ATM expression loss
Tumor deoxyribonucleic acid damage response (DDR) gene mutations present
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Experimental Treatment
Group I: Cohort III (elimusertib, topotecan)Experimental Treatment6 Interventions
Patients receive elimusertib PO QD on days 2 and 5 and topotecan IV over 30 minutes on days 1-5 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT and/or MRI throughout the study, tumor biopsy at screening and on study, and collection of blood samples at screening.
Group II: Cohort II (elimusertib, irinotecan)Experimental Treatment6 Interventions
Patients receive elimusertib PO QD on days 2, 3, 9, 10, 16, and 17 of cycle 1 and 2, and on days 2, 3, 9, and 10 of each cycle thereafter. Patients receive irinotecan IV over 90 minutes on days 1, 8, and 15 of cycle 1 and 2, and on days 1 and 8 of each cycle thereafter. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT and/or MRI throughout the study, tumor biopsy at screening and on study, and collection of blood samples at screening.
Group III: Cohort I (elimusertib, irinotecan)Experimental Treatment6 Interventions
Patients receive elimusertib PO BID on days 1 and 2 and irinotecan IV over 90 minutes on day 1 of each cycle. Cycles repeat every 14 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT and/or MRI throughout the study, tumor biopsy at screening and on study, and collection of blood samples at screening.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biopsy
2014
Completed Phase 4
~1150
Biospecimen Collection
2004
Completed Phase 3
~2030
Computed Tomography
2017
Completed Phase 2
~2790
Irinotecan Hydrochloride
2010
Completed Phase 3
~2050
Magnetic Resonance Imaging
2017
Completed Phase 3
~1180
Topotecan Hydrochloride
2013
Completed Phase 3
~6270
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for lung cancer include chemotherapy, targeted therapy, and immunotherapy. Chemotherapy drugs like irinotecan and topotecan work by interfering with DNA replication, thereby killing rapidly dividing cancer cells.
Targeted therapies, such as tyrosine kinase inhibitors (e.g., osimertinib for EGFR mutations), block specific enzymes involved in cancer cell growth and survival. Immunotherapies, like PD-1/PD-L1 inhibitors, enhance the immune system's ability to recognize and destroy cancer cells.
Enzyme inhibition, as studied with BAY 1895344, is crucial because it can halt tumor growth by blocking essential enzymes needed for cancer cell proliferation. This targeted approach can potentially lead to more effective treatments with fewer side effects, improving outcomes for lung cancer patients.
Find a Location
Closest Location:Siteman Cancer Center at Saint Peters Hospital· Saint Peters, MO
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,938 Previous Clinical Trials
41,023,074 Total Patients Enrolled
Satya DasPrincipal InvestigatorYale University Cancer Center LAO
1 Previous Clinical Trials
18 Total Patients Enrolled
Thatcher HeumannPrincipal InvestigatorYale University Cancer Center LAO
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer treatment includes irinotecan or topotecan.My kidney function, measured by GFR, is normal or above 60.You have had allergic reactions to drugs like BAY 1895344 or other drugs being used in the study.I can swallow pills.Your total bilirubin level should be less than or equal to two times the normal limit at the institution where you are being treated.I have not been treated with irinotecan or topotecan for my condition.Your liver enzyme levels are not more than 3 times the normal limit, or not more than 5 times the normal limit if you have cancer that has spread to the liver.My cancer has spread, can't be surgically removed, and has worsened after treatment.I have at least one tumor that can be measured, not including the one to be biopsied.I stopped taking strong CYP3A4 inhibitors at least a week before starting irinotecan.I am not on medications that strongly affect liver enzymes or can't switch them.I am 18 years old or older.I do not have any unmanaged ongoing illnesses.My doctor has a specific reason if I can't join the study due to brain metastases.I haven't had chemotherapy or radiotherapy in the last 4 to 6 weeks.My hepatitis B virus load is undetectable with treatment.I am HIV-positive, on effective treatment, and my viral load is undetectable.You have a platelet count of at least 100,000 per microliter.I have an infection that needs IV antibiotics.My brain scans show no worsening after treatment for brain metastases and I have no symptoms.Your body has enough infection-fighting white blood cells.You are currently using any other experimental medications.I have advanced lung, neuroendocrine, or pancreatic cancer that has worsened after treatment.I had hepatitis C but have been treated and cured.I can understand and am willing to sign the consent form, or I have someone who can do it for me.I can take care of myself but might not be able to do heavy physical work.Your hemoglobin level is higher than 9 grams per deciliter.I have another cancer type, but it won't affect this trial's treatment.My heart function is classified as class 2B or better according to NYHA.I have recovered from side effects of previous cancer treatments, except for hair loss and hormone issues.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort I (elimusertib, irinotecan)
- Group 2: Cohort II (elimusertib, irinotecan)
- Group 3: Cohort III (elimusertib, topotecan)
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.