Non Hodgkin Lymphoma Clinical Trial

A Study of BTX-1188 in Subjects With Advanced Malignancies

Summary

This is a multicenter, open label, nonrandomized, sequential dose escalation, multiple dose study designed to evaluate the safety, toxicity, and pharmacokinetics (PK) as well as preliminary efficacy of BTX-1188 orally administered in subjects with advanced malignancies.

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Full Description

Study BTX-1188-001 is a multicenter, open label, nonrandomized, sequential dose escalation study to evaluate the safety, toxicity, PK, and preliminary efficacy of BTX-1188. Dose escalation will be conducted in subjects with acute myeloid leukemia (AML) and advanced lymphoid and solid tumors. Based on the results of the dose escalation, a recommended Phase 2 dose will be determined.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Demonstration of understanding and voluntarily signing of an informed consent form
Age ≥ 18 years
Part A - Relapsed or refractory AML, according to the World Health Organization (WHO) classification (Arber, Orazi, et al., 2016). Subjects must be ineligible for or have exhausted standard therapeutic options that would otherwise be likely to provide clinical benefit. Part B - B cell NHL that is refractory to or intolerant of all standard therapy or for which no standard therapy is available or histologically or cytologically documented, incurable or metastatic solid tumor that has failed all available standard therapies with known benefit.
Subjects with solid tumors must have measurable disease per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1). NHL subjects must have bi-dimensionally measurable disease on cross sectional imaging by computed tomography (CT) or magnetic resonance imaging (MRI) as defined by Lugano criteria (Cheson, Fisher, et al., 2014).
Adequate organ function
Females must avoid pregnancy for at least 4 weeks before beginning BTX-1188 therapy, during therapy, during dose interruptions, and for at least 4 weeks after completing therapy and agree to either abstain from sexual intercourse or use two highly effective methods of contraception (for up to 4 weeks after last dose of study drug)
Males sexually active with a woman of childbearing age must agree to use barrier method of birth control during and after the study and not donate sperm (for up to 4 weeks after last dose of study drug).

Exclusion Criteria:

Life expectancy <3 months, as determined by the Investigator.
Treatment with any local or systemic antineoplastic therapy (including chemotherapy, hormonal therapy, or radiation) within 3 weeks prior to first dose of BTX-1188
Immediate life-threatening severe complications of leukemia such as uncontrolled bleeding, pneumonia with hypoxia or shock, and/or disseminated intravascular coagulation
Major trauma or major surgery within 4 weeks prior to first dose of BTX-1188.
Adverse events from prior anti-cancer therapy that have not resolved to Grade ≤1 except for alopecia or Grade ≤2 immunotherapy-related thyroid toxicity.
History of, or known, central nervous system (CNS) disease involvement, or prior history of NCI CTCAE Grade ≥3 drug-related CNS toxicity.
Clinically significant cardiac disease
Active uncontrolled systemic fungal, bacterial, mycobacterial, or viral infection
Known positive test result for human immunodeficiency virus (HIV) or acquired immune deficiency syndrome (AIDS)
Active hepatitis C virus (HCV) or hepatitis B virus (HBV)
Second primary malignancy that has not been in remission for greater than 3 years
Any serious underlying medical (e.g., pulmonary, renal, hepatic, gastrointestinal, or neurological) or psychiatric condition (e.g., alcohol or drug abuse, dementia or altered mental status) or any issue that would limit compliance with study requirements
Pregnant, lactating, or breastfeeding.
Participation or plans to participate in another interventional clinical study.

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Estimated Enrollment:

168

Study ID:

NCT05144334

Recruitment Status:

Recruiting

Sponsor:

BioTheryX, Inc.

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There are 4 Locations for this study

See Locations Near You

City of Hope Medical Center
Duarte California, 91016, United States More Info
Regulatory Coordinator
Contact
[email protected]
Brian Ball
Principal Investigator
Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States More Info
Research Regulatory Associate
Contact
[email protected]
Eytan Stein
Principal Investigator
The Christ Hospital
Cincinnati Ohio, 45219, United States More Info
Abby Reed
Contact
Alexander Starodub, MD, PhD
Principal Investigator
M.D. Anderson Cancer Center
Houston Texas, 77030, United States More Info
Clinical Research Program Coordinator
Contact
[email protected]
Gautam Bortakur
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Estimated Enrollment:

168

Study ID:

NCT05144334

Recruitment Status:

Recruiting

Sponsor:


BioTheryX, Inc.

How clear is this clinincal trial information?

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