BAY1895344 for Lymphoma

Phase-Based Estimates
1
Effectiveness
1
Safety
National Cancer Center Singapore, Singapore, Singapore
Lymphoma+1 More
BAY1895344 - Drug
Eligibility
18+
All Sexes
Eligible conditions
Lymphoma

Study Summary

This study is evaluating whether a drug may help treat cancer.

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Eligible Conditions

  • Lymphoma
  • Cancer
  • Neoplasms

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether BAY1895344 will improve 7 primary outcomes and 3 secondary outcomes in patients with Lymphoma. Measurement will happen over the course of Up to 30 days after end of treatment.

Day 10
AUC (area under the plasma concentration of BAY1895344 vs. time curve) from zero to 12 hours after single-dose (C1D1) and multiple-dose administrations (C1D10)
Cmax of BAY1895344 in cycle 1 after single-dose (C1D1) and multiple-dose administrations (C1D10)
Day 21
Incidence of DLTs during Cycle 1 in dose-escalation cohorts during J-arm of the study
Incidence of DLTs during Cycle 1 in dose-escalation cohorts during Part A of the study
Day 28
Incidence of DLTs during Cycle 1 in dose-escalation cohorts during Part A.1 of the study
Month 4
Incidence of castration resistant prostate cancer patients with CR, PR, SD or PD consistent with the recommendations of the Prostate Cancer Working Group 3 (PCWG3)
Incidence of lymphoma patients with CR, PR, SD or PD consistent with the Lugano Classification
Incidence of patients with CR, PR, SD or PD (except for patients with castration resistant prostate cancer) consistent with the RECIST 1.1 criteria
Day 30
The incidence of serious and nonserious treatment-emergent adverse events (TEAEs)
Month 6
The maximum tolerated dose (MTD) and / or recommended Phase II dose (RP2D) of BAY1895344

Trial Safety

Trial Design

4 Treatment Groups

No Control Group
Dose escalation of BAY1895344 in Part A

This trial requires 241 total participants across 4 different treatment groups

This trial involves 4 different treatments. BAY1895344 is the primary treatment being studied. Participants will be divided into 4 treatment groups. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

Dose escalation of BAY1895344 in Part A
Drug
Single-agent dose-escalation part. Part A has the objective to define the MTD and / or RP2D.
J-arm of Part A
Drug
Single-agent dose-escalation part in Japanese patients. J-arm has the objective to confirm the MTD (or RP2D) dose is safe and tolerable in Japanese patients.
Part A.1: Single-agent dose escalation part
Drug
Part A.1 - single-agent dose escalation part with alternative dosing schedule Patients with histologically confirmed solid tumors or NHL known to be positive for ATM loss and/or ATM deleterious mutations will be included.
Dose expansion of BAY1895344 in Part B
Drug
Single-agent expansion part. Once the MTD has been defined, safety, PK profile, PD of target engagement, and preliminary efficacy will be further evaluated in Part B of the study. Once the MTD dose has been confirmed is safe and tolerable in Japanese patients, safety, PK profile, PD of target engagement, and preliminary efficacy will be further evaluated in Part B of the study.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: through study completion, an average of 4 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly through study completion, an average of 4 months for reporting.

Closest Location

Integrated Cancer Center of the CHU de Québec - Quebec, Canada

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Before enrolling patients into general screening, their biomarker status will be evaluated and only those with the putative biomarkers of DDR deficiency will be recruited. show original
Patients with histologically confirmed cancer, regardless of the cancer type, or NHL who have lost ATM protein by IHC. show original
Patients with DDR deficiency marker-positive advanced solid tumors of the following histologies: CRPC (castration-resistant prostate cancer), HER2-negative BC (hormone-receptor positive: estrogen-receptor positive, progesterone-receptor positive, or both), CRC (colorectal cancer), and gynecological tumors (ovarian, primary peritoneal, and fallopian tube cancers, endometrial cancer, or cervical cancer). show original
The Eastern Cooperative Oncology Group (ECOG) performance status is 0 to 1. show original
- People with histologically confirmed solid tumors or NHL that are known to have lost ATM or have ATM mutations that could lead to cancer will be included. show original
Patients with tumors that are resistant to or don't respond to standard treatment and for which the investigator believes that experimental treatment with BAY1895344 may be beneficial, will be allowed to participate in the study show original
patients with chronic erythropoietin treatment who have a hemoglobin level of at least 9 grams per deciliter can be included in the study. show original
- People who have been diagnosed with a solid tumor or non-Hodgkin's lymphoma. show original
This study will test different doses of a new drug in Japanese patients with solid tumors show original
A phase 1, open-label, multicenter, single-agent dose escalation part with an alternative dosing schedule will be conducted in patients with advanced solid tumors show original

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is lymphoma?

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In an era of more effective treatment strategies, a growing cancer burden and an aging population, lymphomas remain amongst the most devastating malignancies. More aggressive strategies to improve survival, disease-free survival and quality of life are urgently required.

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What is the primary cause of lymphoma?

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Although the primary cause of lymphoma remained elusive after several decades, there could have been different lymphoma subtypes, which would support some of the above mentioned theories. An improved understanding of lymphoma pathogenic mechanisms is crucial, in order to elucidate its mechanisms of occurrence and development.

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What are the signs of lymphoma?

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After completing the first year of treatment, it is extremely important for patients to consult their doctors frequently. In order to find out whether they are progressing to a second relapse, they should contact their doctors from time to time and seek advice if any of the symptoms that come up at the beginning (exophthalmos, swelling in the eyes) don’t go away. They need to be seen by a doctor as often as they need to get specialist treatment to prevent the recurrence. They should be informed about all the symptoms that can appear during treatment (excessive weight loss, fever, swelling, loss of appetite).

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How many people get lymphoma a year in the United States?

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Around 23,000 Americans are diagnosed with lymphoma each year. The five-year survival rate for patients diagnosed with lymphoma is around 60%. This compares to 90% five-year survival in the matched non-lymphoma population, which is thought to be attributable to the earlier diagnosis of lymphoma, as well as better control of other cancers. This supports the evidence, based on mortality, of early detection of lymphoma, and the need for early diagnosis.

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What are common treatments for lymphoma?

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Treatment options for newly diagnosed patients with NHL are very versatile. For patients with early stage disease and few risk factors, a good response to a single agent of chemotherapy is predicted. The use of several drugs in combination may be more effective and better tolerated. For patients with high-risk disease, chemotherapy should be given only in combination with other treatments. In these patients, high dose chemotherapy may result in significant toxicity, although with less complete remission. The current approach of treating NHL in this way does not reflect all three dimensions of the disease: (1) bulky disease, (2) relapsed or refractory disease and (3) advanced stage disease.

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What causes lymphoma?

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Lymphoma is an inflammatory disease. As cancer of lymphocytes, it is thought to be initiated by abnormalities in B-cell development but not A-cells. The major risk factors for lymphoma are ultraviolet radiation and ionising irradiation, and immunosuppression of any cause. The link between ionising radiation and lymphoma was first recognised in the 1930s. The most common types have similar causes and treatments.

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Does lymphoma run in families?

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If you have a family history of lymphoma, take time to explain the disease in the family and discuss this information with your physicians. The disease can run in families and your physicians should take into account what could take place and which members could be affected.

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What does bay1895344 usually treat?

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This combination has significant antitumor activity and has demonstrated better rates of stabilization and stabilization plus remission than the comparator agent rituximab plus doxorubicin chemotherapy.

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Have there been any new discoveries for treating lymphoma?

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There are various types of lymphomas with the similar morphologic patterns that occur among the several types of malignancies in which lymphocytes and other lymphoid cells, including their abnormal precursor cells are attacked in the same way. Hence, all have been treated by the same methods, so far. However, many more lymphomas would be discovered in the future, but we cannot predict the future. We can only start with what we know today. Results from a recent paper of some of the new methods, drugs and new types of lymphoma treatment such as autologous bone marrow transplant, and stem cell transplant are already encouraging.

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What is the survival rate for lymphoma?

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These figures show that the prognosis for NHL varies with age in addition to the extent of disease at diagnosis. Most of the newly diagnosed patients have an excellent outcome with current treatment. The data on late-stage patients indicate that a sizeable proportion of patients with early-stage disease may still achieve prolonged survival or even be cured using modern treatment protocols. Patients who present with late-stage disease appear to have a significantly poorer outcome due to progression, progression of the disease and/or failure of current treatment.

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How quickly does lymphoma spread?

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It takes from 2 days to 10 weeks for the lymphoma cells to migrate from the affected site to distant bone marrow sites. Spread of the lymphoma to other sites and subsequent involvement of these sites is also seen and most probably occurs because of direct invasion of lymphoma cells into blood circulation.

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