A Study of BTX-1188 in Subjects With Advanced Malignancies

NCT ID: NCT05144334

Last Updated: 2023-09-18

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-24
• Study Completion Date: 2023-09-12

Brief 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.

Detailed 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.

Conditions

Advanced Solid Tumor; Non Hodgkin Lymphoma; Acute Myeloid Leukemia

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

BTX-1188 Dose Cohort 1

Starting dose of BTX-1188 administered orally per dosing schedule

Group Type: EXPERIMENTAL

BTX-1188

Intervention Type: DRUG

One 28 day cycle of treatment will consist of 4 weeks of treatment with BTX-1188 administered orally per dosing schedule.

BTX-1188 Dose Cohort 2

First dose escalation of BTX-1188 administered orally per dosing schedule

Group Type: EXPERIMENTAL

BTX-1188

Intervention Type: DRUG

One 28 day cycle of treatment will consist of 4 weeks of treatment with BTX-1188 administered orally per dosing schedule.

BTX-1188 Dose Cohort 3

Second dose escalation of BTX-1188 administered orally per dosing schedule

Group Type: EXPERIMENTAL

BTX-1188

Intervention Type: DRUG

One 28 day cycle of treatment will consist of 4 weeks of treatment with BTX-1188 administered orally per dosing schedule.

BTX-1188 Dose Cohort 4

Third dose escalation of BTX-1188 administered orally per dosing schedule

Group Type: EXPERIMENTAL

BTX-1188

Intervention Type: DRUG

One 28 day cycle of treatment will consist of 4 weeks of treatment with BTX-1188 administered orally per dosing schedule.

BTX-1188 Dose Cohort 5

Fourth dose escalation of BTX-1188 administered orally per dosing schedule

Group Type: EXPERIMENTAL

BTX-1188

Intervention Type: DRUG

One 28 day cycle of treatment will consist of 4 weeks of treatment with BTX-1188 administered orally per dosing schedule.

BTX-1188 Dose Cohort 6

Fifth dose escalation of BTX-1188 administered orally per dosing schedule

Group Type: EXPERIMENTAL

BTX-1188

Intervention Type: DRUG

One 28 day cycle of treatment will consist of 4 weeks of treatment with BTX-1188 administered orally per dosing schedule.

BTX-1188 Dose Cohort 7

Sixth dose escalation of BTX-1188 administered orally per dosing schedule

Group Type: EXPERIMENTAL

BTX-1188

Intervention Type: DRUG

One 28 day cycle of treatment will consist of 4 weeks of treatment with BTX-1188 administered orally per dosing schedule.

Interventions

BTX-1188

One 28 day cycle of treatment will consist of 4 weeks of treatment with BTX-1188 administered orally per dosing schedule.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Biotheryx, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tracy Lawhon

Role: STUDY_DIRECTOR

Biotheryx, Inc.

Locations

City of Hope Medical Center

Duarte, California, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

The Christ Hospital

Cincinnati, Ohio, United States

M.D. Anderson Cancer Center

Houston, Texas, United States

Countries

United States

Other Identifiers

BTX-1188-001

Identifier Type: -

Identifier Source: org_study_id