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Antibody-Drug Conjugate

Part 1 (STI-6129) for Acute Myeloid Leukemia

Phase 1

Waitlist Available

Led By Abhishek Maiti, MBBS

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through completion of study or an average of 1 year.

Awards & highlights

Study Summary

This trial is testing a new cancer drug to see if it is safe and effective for people with T-ALL or AML who have run out of other treatment options.

Eligible Conditions

T-Cell Acute Lymphoblastic Leukemia
Acute Myeloid Leukemia

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through completion of study or an average of 1 year.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through completion of study or an average of 1 year.

This trial's timeline: 3 weeks for screening, Varies for treatment, and through completion of study or an average of 1 year. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Severity of the adverse events (Aes) -The severity of the adverse events (Aes) will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) V.5

Trial Design

2Treatment groups

Experimental Treatment

Group I: Part 2 (dose expansion)Experimental Treatment2 Interventions

Participants will receive the dose of STI-6129 found in Part 1 of the study.

Group II: Part 1 (dose escalation)Experimental Treatment2 Interventions

Participants of the first group will receive the lowest dose level. Participants of each new group will receive a higher dose than the group before it, if no intolerable side effects were seen. This will continue until the highest tolerable dose of STI-6129 is found.

Do I qualify?Apply below to find out

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Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor

2,974 Previous Clinical Trials

1,789,396 Total Patients Enrolled

Abhishek Maiti, MBBSPrincipal Investigatoramaiti@mdanderson.org

1 Previous Clinical Trials

235 Total Patients Enrolled

Frequently Asked Questions

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

Are there any opportunities currently available to join this experiment?

"Evidently, the clinicaltrial.gov registry does not indicate that this trial is actively recruiting patients at present. After being posted on February 28th 2023 and edited as recently as September 22nd 2022, this study has ceased its search for candidates; however 1620 other studies are currently seeking participants."

Answered by AI

What have the safety assessments revealed about Part 1 (STI-6129)?

"Our team at Power has estimated the safety of Part 1 (STI-6129) to be a 1 as it is currently in its first phase, thus there exists only minimal data on both safety and efficacy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

STI-6129 CD38 ADC for the Treatment of Patients With Relapsed or Refractory Systemic ALL Amyloidosis

2022. "STI-6129 CD38 ADC for the Treatment of Patients With Relapsed or Refractory Systemic ALL Amyloidosis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05519527.