PLM-102 for Acute Myeloid Leukemia

Overseen By Abhishek Maiti, MBBS

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: M.D. Anderson Cancer Center

Must not be taking: Cytotoxic chemotherapy, targeted therapy

Disqualifiers: Uncontrolled infections, heart failure, hepatitis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 4 cycles

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine the highest safe dose of a new treatment called PLM-102 for individuals with certain types of blood cancer, specifically acute myeloid leukemia (AML) that has returned or not responded to treatment. The focus is on assessing the body's tolerance to this new drug. Individuals who have tried standard treatments for their AML but still show signs of the disease might be suitable candidates for this trial. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify if you must stop taking your current medications. However, you cannot have used any cytotoxic chemotherapy, targeted therapy, radiation therapy, or immunotherapy within 2 weeks before starting the study treatment. You may continue using hydroxyurea or cytarabine to control white blood cell count during this period.

Is there any evidence suggesting that PLM-102 is likely to be safe for humans?

Research has shown that PLM-102 has undergone safety testing in people with acute myeloid leukemia (AML). In these studies, researchers examined side effects during treatment and those that might limit the drug's safe dosage. The aim was to assess how well participants could tolerate the treatment.

This trial is in an early stage, primarily focusing on safety. Results so far suggest that PLM-102 is tolerated, though specific details about side effects are not provided. During testing, researchers closely monitor for any safety issues. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for AML?

PLM-102 is unique because it introduces a novel mechanism of action targeting specific cancer cell pathways in acute myeloid leukemia (AML), which current treatments like chemotherapy and targeted therapies may not address as effectively. Unlike standard treatments that often come with severe side effects due to their broad attack on both healthy and cancerous cells, PLM-102 is designed to be more precise, potentially reducing collateral damage to healthy cells. Researchers are excited about PLM-102 because it offers the possibility of a more targeted and outpatient-friendly treatment option for AML patients, which could improve quality of life and outcomes.

What evidence suggests that PLM-102 might be an effective treatment for AML?

Research has shown that PLM-102 could be a promising treatment for acute myeloid leukemia (AML), particularly when current treatments fail. In early studies with mice, PLM-102 effectively targeted AML cells. This drug focuses on a protein called FLT3, which often mutates in AML and can promote cancer growth. PLM-102 is designed to remain effective even when other FLT3-targeting drugs do not, potentially offering more benefits for some patients. Although human studies have provided limited information, these results suggest PLM-102 could be a new option for those with recurrent or treatment-resistant AML. Participants in this trial will receive PLM-102 in a dose escalation format to assess its safety and effectiveness. ^{1 3 5 6 7}

Who Is on the Research Team?

Abhishek Maiti, MBBS

Principal Investigator

UT MD Anderson

Are You a Good Fit for This Trial?

This trial is for adults with acute myeloid leukemia (AML) or related disorders that have come back or not responded to previous treatments. Participants must have good liver and kidney function, be able to care for themselves, and agree to use birth control if needed.

Inclusion Criteria

I am able to care for myself and do daily activities.

I have tried or am not eligible for all approved treatments for my cancer mutation.

I had a blood disorder, was treated for it, and now have developed AML.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive PLM-102 in a dose escalation format to determine the highest tolerable dose

4 cycles

Outpatient basis

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Long-term follow-up

Participants are monitored for adverse events and overall survival

Up to 1 year

What Are the Treatments Tested in This Trial?

Interventions

• PLM-102

Trial Overview

The study is testing different doses of a new drug called PLM-102 in people with relapsed or hard-to-treat AML. The main goal is to find the safest highest dose and check how well patients tolerate it.

How Is the Trial Designed?

Group I: Dose Escalation of PLM-102 Experimental Treatment 1 Intervention

Treatment will be adminstered on an outpatient basis

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07549464

Phase I Study Of PLM-102 In Patients With Relapsed And ...

The goal of this clinical research study is to find the highest tolerable dose of PLM-102 that can be given to patients who have AML/MDS that is refractory ...

2.

withpower.com

withpower.com/trial/phase-1-leukemia-myeloid-acute-9-2026-827f5

PLM-102 for Acute Myeloid Leukemia · Info for Participants

The goal of this clinical research study is to find the highest tolerable dose of PLM-102 that can be given to patients who have AML/MDS that is refractory ...

3.

ascopubs.org

ascopubs.org/doi/10.1200/JCO.2022.40.16_suppl.e15103

Development of PLM-102, a novel dual inhibitor of FLT3 ...

Moreover, PLM-102 showed an excellent anti-tumor activity in mouse xenograft models implanted with MV4-11 and MOLM-14 AML cells. Conclusions: ...

4.

aacrjournals.org

aacrjournals.org/cancerres/article/83/7_Supplement/4009/724708/Abstract-4009-Discovery-of-PLM-102-a-highly-potent

Discovery of PLM-102, a highly potent 3rd generation FLT3 ...

PLM-102 is a promising therapeutic candidate for the FLT3-ITD-mutated AML as well as the acquired resistance to current FLT3 inhibitors.

5.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0006497123095216

Plm-102, a Next Generation FLT3 Inhibitor, Shows Potent ...

Herein, we report a next-generation drug candidate, PLM-102, which has shown promising pre-clinical results to overcome the current unmet needs ...

6.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/41729312/

Safety profile of FLT3 inhibitors in acute myeloid leukemia

Safety profile of FLT3 inhibitors in acute myeloid leukemia: a systematic review and meta-analysis of adverse events · Authors · Affiliations.

7.

sciencedirect.com

sciencedirect.com/science/article/pii/S0753332224016755

Targeting FMS-like tyrosine kinase 3 (FLT3) in acute ...

Phase 1 clinical trial on 24 patients with R/R AML confirmed the safety profile, but the mAB failed to achieve clinical efficacy [183]. To address the lack of ...