Tegavivint for the Treatment of Relapsed or Refractory Leukemia

January 7, 2026 updated by: M.D. Anderson Cancer Center

Phase I Study of Tegavivint (BC-2059) in Patients With Relapsed and Refractory Leukemias

This phase I trial is to find out the best dose and side effects of tegavivint in treating patients with leukemia that has come back (relapsed) or does not response to treatment (refractory). Tegavivint may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving tegavivint in combination with decitabine may help control the disease.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVES:

I. To determine the maximum tolerated dose (MTD) and dose limiting toxicities (DLT) of tegavivint in patients with relapsed and refractory acute myeloid leukemia (AML). (Phase I dose escalation) II. To determine the maximum tolerated dose (MTD) and dose limiting toxicities (DLT) of tegavivint combined with decitabine in patients with relapsed and refractory acute myeloid leukemia (AML). (Combination cohort)

SECONDARY OBJECTIVES:

I. To assess the safety profile of tegavivint as characterized by adverse event (AE) type, severity, timing and relationship to study drug, as well as laboratory abnormalities in the first and subsequent treatment cycles. (Phase I dose escalation) II. To explore the efficacy (complete remission [CR], complete remission without blood count recovery [CRi], or partial remission [PR], of tegavivint as a single-agent in patients with relapsed/refractory (R/R) AML. (Phase I dose escalation) III. To assess overall survival (OS), and disease-free survival (DFS) in patients with R/R AML treated with tegavivint. (Phase I dose escalation) IV. To assess the duration of disease control defined as first date of disease control identified (either CR/CRi, PR or SD) until the date of progression. (Phase I dose escalation) V. To explore biomarkers of response and resistance in patients with R/R AML treated with tegavivint. (Phase I dose escalation) VI. To assess the safety profile of tegavivint in combination with decitabine as characterized by adverse event (AE) type, severity, timing and relationship to study drug, as well as laboratory abnormalities in the first and subsequent treatment cycles. (Combination cohort) VII. To explore the efficacy (complete response [CR], complete response without blood count recovery [CRi], or partial response [PR], of tegavivint in combination with decitabine in patients with R/R AML. (Combination cohort) VIII. To assess overall survival (OS), and disease free survival (DFS) in patients with R/R AML treated with tegavivint + decitabine. (Combination cohort) IX. To assess the duration of disease control defined as first date of disease control identified (either CR/ CRi, PR or SD) until the date of progression. (Combination cohort) X. To explore biomarkers of response and resistance in patients with R/R AML treated with tegavivint + decitabine. (Combination cohort)

OUTLINE: This is a dose-escalation study.

PART I: Patients receive tegavivint intravenously (IV) over 4 hours on days 1, 8, 15, and 22. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

PART II: Patients receive tegavivint IV over 4 hours on days 1, 8, 15, and 22 and decitabine IV over 30-60 minutes on days 1-5. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 30 days.

Study Type

Interventional

Enrollment (Actual)

9

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • M D Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients with a diagnosis of histologically confirmed relapsed or refractory (R/R) acute myeloid leukemia for which no available standard therapies are indicated or anticipated to result in a durable response
  • Age >= 18 years
  • Patients must not have had leukemia therapy for 14 days prior to starting tegavivint (BC-2059). However, patients with rapidly proliferative disease may receive hydroxyurea as needed until 24 hours prior to starting therapy on this protocol and during the first cycle of study
  • Bilirubin =< 2.5 mg/dL
  • Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) =< 3 x upper limit of normal (ULN) - or =< 5 x ULN if related to leukemic involvement
  • Creatinine =< 1.5 x ULN
  • Known cardiac ejection fraction of > or = 45% within the past 3 months
  • Eastern Cooperative Oncology Group (ECOG) performance status of =< 2
  • A negative urine pregnancy test is required within 1 week for all women of childbearing potential prior to enrolling on this trial
  • Patient must have the ability to understand the requirements of the study and signed informed consent. A signed informed consent by the patient or his legally authorized representative is required prior to their enrollment on the protocol

Exclusion Criteria:

  • Pregnant women are excluded from this study because the agent used in this study has the potential for teratogenic or abortifacient effects. Because there is a potential risk for adverse events in nursing infants secondary to treatment of the mother with the chemotherapy agents, breastfeeding should also be avoided
  • Uncontrolled intercurrent illness including, but not limited to active uncontrolled infection, symptomatic congestive heart failure (New York Heart Association [NYHA] class III or IV), unstable angina pectoris, clinically significant cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • Patient with documented hypersensitivity to any of the components of the therapy program
  • Patients with active, uncontrolled central nervous system (CNS) leukemia will not be eligible
  • Men and women of childbearing potential who do not practice contraception. Women of childbearing potential and men must agree to use at least 1 form of barrier birth control (such as condom) prior to study entry and for the duration of study participation
  • Prior treatment with tegavivint

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment (tegavivint, decitabine)

PART I: Patients receive tegavivint IV over 4 hours on days 1, 8, 15, and 22. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

PART II: Patients receive tegavivint IV over 4 hours on days 1, 8, 15, and 22 and decitabine IV over 30-60 minutes on days 1-5. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Drug: Decitabine
Given IV
Other Names:
  • Dacogen
  • Decitabine for Injection
  • Deoxyazacytidine
  • Dezocitidine
  • 5-Aza-2''-deoxycytidine
Drug: Tegavivint
Given IV
Other Names:
  • BC 2059
  • BC-2059
  • BC2059
  • Tegatrabetan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of adverse events
Time Frame: Up to 2 years
Adverse events will be tabulated with frequency and percentage by grade, attribution to treatment, and by dose level/schedule.
Up to 2 years
Response rate
Time Frame: Up to 2 years
Response rate will be estimated alone with 95% confidence interval.
Up to 2 years
Overall survival
Time Frame: From date of treatment start until date of death due to any cause, assessed up to 2 years
Will be estimated using the Kaplan-Meier method.
From date of treatment start until date of death due to any cause, assessed up to 2 years
Disease free survival
Time Frame: From date of complete response (CR), or complete remission without blood count recovery (CRi) until the date of first objective documentation of disease-relapse or death, assessed up to 2 years
Will be estimated using the Kaplan-Meier method.
From date of complete response (CR), or complete remission without blood count recovery (CRi) until the date of first objective documentation of disease-relapse or death, assessed up to 2 years
Duration of disease control
Time Frame: Up to 2 years
Will be estimated using the Kaplan-Meier method.
Up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Investigators

  • Principal Investigator: Tapan M Kadia, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 27, 2021

Primary Completion (Estimated)

February 2, 2027

Study Completion (Estimated)

February 2, 2027

Study Registration Dates

First Submitted

May 2, 2021

First Submitted That Met QC Criteria

May 2, 2021

First Posted (Actual)

May 5, 2021

Study Record Updates

Last Update Posted (Actual)

January 9, 2026

Last Update Submitted That Met QC Criteria

January 7, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-0616 (Other Identifier: M D Anderson Cancer Center)
  • NCI-2021-03253 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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