ICP-248 + Azacitidine for Acute Myeloid Leukemia

Recruiting at 14 trial locations

Overseen By Alexia Lu

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Beijing InnoCare Pharma Tech Co., Ltd.

Must be taking: Azacitidine

Must not be taking: BCL-2 inhibitors

Disqualifiers: CNS leukemia, Active hepatitis, HIV, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 8-12 weeks

266 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new combination of drugs, ICP-248 (an experimental treatment) with azacitidine, to determine its safety and effectiveness for certain blood cancers, specifically acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS). Researchers aim to discover if this combination can benefit those whose conditions have not responded to previous treatments or are newly diagnosed but cannot undergo intense chemotherapy. Individuals with AML (excluding the APL type) or MDS, whose daily life is impacted by these conditions, might be suitable candidates. Participants must have a life expectancy of at least 12 weeks and adequate kidney and liver function. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new therapy.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that azacitidine is already a standard treatment for some blood cancers, indicating its general safety. However, it can cause side effects like low blood cell counts, nausea, and tiredness. Specific safety information for ICP-248 is not yet available. As this study is in its early stages, it primarily aims to assess the safety and tolerability of ICP-248. Researchers are still learning how well people tolerate ICP-248 when combined with azacitidine. Participants might experience side effects, but the study closely monitors and manages these. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Most treatments for acute myeloid leukemia (AML) work by targeting rapidly dividing cells, but ICP-248 works differently by specifically targeting and inhibiting certain proteins that contribute to the growth of cancer cells. This targeted approach can potentially lead to fewer side effects compared to traditional chemotherapy options. Researchers are excited about this because it represents a new mechanism of action, which could improve treatment outcomes and offer hope for patients who have not responded well to existing therapies like cytarabine or daunorubicin.

What evidence suggests that ICP-248 in combination with azacitidine could be effective for acute myeloid leukemia?

Research has shown that using ICP-248 with azacitidine, the combination studied in this trial, may help treat acute myeloid leukemia (AML). Studies have found that patients tolerate this combination well, leading to complete remission (when all signs of cancer disappear) in 32% of cases. This is particularly promising for patients with a specific gene mutation called TP53, which is usually harder to treat. Azacitidine is a chemotherapy drug that stops cancer cells from growing, while ICP-248 is believed to enhance the immune system's ability to fight leukemia. Early research suggests this combination might offer new hope for those battling AML. ^{1 3 5 6 7}

Are You a Good Fit for This Trial?

This trial is for adults with acute myeloid leukemia (AML) or Myelodysplastic Syndromes (MDS), who have relapsed after previous treatments. Participants need to be over 60, or if younger, unfit for intensive chemotherapy due to certain health issues. They must have a life expectancy of at least 12 weeks and good liver and kidney function.

Inclusion Criteria

I have been diagnosed with AML or MDS, not including APL.

My doctor expects me to live at least 12 more weeks.

I have AML that didn't respond to previous treatments.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive ICP-248 in combination with azacitidine

8-12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Azacitidine
• ICP-248

Trial Overview

The trial tests the combination of ICP-248 with azacitidine in patients with AML or MDS. It aims to assess how safe and tolerable this mix is, understand how the body processes it, and see its initial effectiveness against these blood disorders.

How Is the Trial Designed?

Group I: ICP-248 in combination with azacitidine Experimental Treatment 2 Interventions

Who Is Running the Clinical Trial?

Beijing InnoCare Pharma Tech Co., Ltd.

Lead Sponsor

Trials

48

Recruited

6,000+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06656494

NCT06656494 | ICP-248 in Combination With Azacitidine ...

Evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of ICP-248 in combination with azacitidine in patients with acute myelogenous ...

2.

clinicaltrials.med.nyu.edu

clinicaltrials.med.nyu.edu/clinicaltrial/2906/phase-1-study-icp-248/

A Phase 1 Study of ICP-248 in Combination with Azacitidine ...

The goal of this study is to check the safety, how the drug moves through the body (pharmacokinetics, or PK), and early signs of how well ICP-248 works when ...

3.

aacrjournals.org

aacrjournals.org/bloodcancerdiscov/article/5/4/234/746106/Recent-Advances-in-Immune-Based-Therapies-for

Recent Advances in Immune-Based Therapies for Acute ...

The treatment was relatively well tolerated and induced 32% of CR with higher clinical efficacy and promising results in patients with TP53- ...

4.

centerwatch.com

centerwatch.com/clinical-trials/listings/NCT06656494/icp-248-in-combination-with-azacitidine-in-treatment-naive-subjects-with-acute-myelogenous-leukemiaaml-or-previously-treated-relapsed-refractory-subjects-with-acute-myelogenous-leukemiarr-aml

ICP-248 in Combination With Azacitidine for the Treatment ...

Evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of ICP-248 in combination with azacitidine in patients with acute ...

5.

ichgcp.net

ichgcp.net/amp/clinical-trials-registry/NCT06656494

ICP-248 and Azacitidine in Acute Myelogenous Leukemia and ...

Evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of ICP-248 in combination with azacitidine in patients with acute myelogenous ...

6.

trialfinder.panfoundation.org

trialfinder.panfoundation.org/en-US/trial/listing/550839

ICP-248 in Combination With Azacitidine for the Treatment ...

Evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of ICP-248 in combination with azacitidine in patients with acute myelogenous ...

7.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/39721469/

Combination therapy involving azacitidine for acute ...

Despite advances in treatment, elderly AML patients face suboptimal survival outcomes, with an estimated 5-year survival rate below 20 %. Epigenetic ...