ABBV-787 for Acute Myeloid Leukemia

No longer recruiting at 32 trial locations

Overseen By ABBVIE CALL CENTER

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: AbbVie

Must not be taking: CD33-targeting therapy

Disqualifiers: Stem cell transplant, Pneumonitis, SARS-CoV-2, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 3 years

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a new drug, ABBV-787, for individuals with acute myeloid leukemia (AML) that has returned or did not respond to treatment. Researchers seek to determine the drug's safety and behavior in the body. Participants will receive increasing doses to identify the highest safe amount. The trial seeks adults with AML who have tried up to three other treatments without success and are experiencing symptoms that affect daily life. Participants must visit the hospital or clinic regularly and may face a higher treatment burden than standard care. 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 need to stop my current medications for this trial?

The trial protocol does not specify if you must stop all current medications. However, you cannot have received anticancer therapy, including chemotherapy, radiation, immunotherapy, biologic, or investigational therapy, within 14 days or 5 half-lives of the drug before starting ABBV-787. Hydroxyurea or leukapheresis is allowed to control white blood cell count.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot have received certain cancer treatments within 14 days before starting the trial drug. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that ABBV-787 is likely to be safe for humans?

Research has shown that ABBV-787 is under study to assess its safety for people with acute myeloid leukemia (AML). In these studies, scientists evaluate patient tolerance and potential side effects. Since ABBV-787 is in an early testing phase, its efficacy and safety remain unknown, resulting in limited information about its safety in humans.

Researchers aim to determine the highest dose that can be taken without serious side effects. Participants receive varying doses to identify the most effective and safe amount. While this process prioritizes safety, it also involves some risks and unknowns. As more participants join, researchers will gather additional data on ABBV-787's safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for acute myeloid leukemia, which often involve chemotherapy and stem cell transplants, ABBV-787 is unique because it focuses on targeting specific cancer pathways with a new mechanism of action. Researchers are excited about ABBV-787 because it uses a novel approach to selectively attack leukemia cells, potentially leading to more effective outcomes with fewer side effects. This targeted strategy could mean better results for patients who have had limited success with existing options.

What evidence suggests that ABBV-787 might be an effective treatment for acute myeloid leukemia?

Research has shown that ABBV-787 is being tested as a potential treatment for acute myeloid leukemia (AML), particularly in patients whose cancer has returned or hasn't responded to other treatments. Participants in this trial will receive increasing doses of ABBV-787 until reaching the maximum tolerated dose during the 3-year treatment period. Early studies focus on understanding how ABBV-787 works in the body and its safety. This experimental drug targets specific cancer cells to fight AML. This approach is promising because it directly attacks the cancer cells, potentially leading to effective treatment results. Although information on its efficacy is limited, similar treatments at this stage have shown a 68% success rate in advancing to further testing. ^{1 2 3 6 7}

Who Is on the Research Team?

ABBVIE INC.

Principal Investigator

AbbVie

Are You a Good Fit for This Trial?

This trial is for adults with Acute Myeloid Leukemia (AML) who have tried up to three treatments without success. They should be in good physical condition (ECOG score of 0 or 1), have acceptable heart health, and a white blood cell count below a certain level. People can't join if they've had more than three prior AML treatments or don't meet specific health criteria.

Inclusion Criteria

You meet the laboratory standards specified in the protocol.

I have AML that didn't respond to 3 or fewer treatments and can't tolerate standard therapies.

I am fully active or can carry out light work.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive intravenous (IV) infusions of ABBV-787 in escalating doses until the maximum tolerated dose (MTD) is determined

Up to 3 years

Regular visits at a hospital or clinic

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• ABBV-787

Trial Overview The study tests the safety and behavior of ABBV-787, an experimental drug for AML, when given through IV. Participants will receive increasing doses to find the highest dose they can tolerate without severe side effects over approximately three years.

How Is the Trial Designed?

Group I: ABBV-787 Experimental Treatment 1 Intervention

Participants will receive increasing doses of ABBV-787 until the maximum tolerated dose (MTD) during the 3 year treatment period.

Who Is Running the Clinical Trial?

AbbVie

Lead Sponsor

Trials

1,079

Recruited

535,000+

Founded

2013

Headquarters

North Chicago, USA

Known For

Immunology treatments

Top Products

Humira (adalimumab), Skyrizi (risankizumab), Rinvoq (upadacitinib)

Dr. Roopal Thakkar

AbbVie

Chief Medical Officer since 2023

MD from Wayne State University School of Medicine

Robert A. Michael

AbbVie

Chief Executive Officer

Bachelor's degree in Finance from the University of Illinois

Published Research Related to This Trial

A study analyzing 6 transcriptomic datasets of acute myeloid leukemia (AML) found that wild-type FLT3 patients exhibited a gene expression pattern similar to those with FLT3 mutations, suggesting they may also benefit from FLT3 inhibitors.

This FLT3 mutation-like pattern was particularly enriched in patients with NPM1 and DNMT3A mutations, indicating that these genetic factors could help predict responses to FLT3 inhibitors in wild-type FLT3 AML patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gene expression profiling identifies FLT3 mutation-like cases in wild-type FLT3 acute myeloid leukemia. Mosquera Orgueira, A., Peleteiro Raíndo, A., Cid López, M., et al.[2022]

In a study involving 38 adult patients with relapsed or refractory acute myeloid leukemia, VP-16-213 demonstrated an overall response rate of 18%, with 5% achieving complete remission and 13% partial remission.

The treatment was associated with mild toxicity and rare instances of aplasia, showing that it is a relatively safe option for patients across all myeloid subtypes, including those who had never achieved remission.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A phase II trial of VP 16-213 in adults with refractory acute myeloid leukemia. An Eastern Cooperative Oncology Group study. Bennett, JM., Lymann, GH., Cassileth, PA., et al.[2019]

Acute myeloid leukemia (AML) is the most common acute leukemia in adults, with over 20,000 new cases annually in the U.S., and is characterized by genetic mutations that influence prognosis and treatment strategies.

Current treatment primarily involves cytarabine- and anthracycline-based regimens, along with allogeneic stem cell transplantation for eligible patients, but elderly patients often face challenges tolerating these therapies, leading to poorer outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

'Acute myeloid leukemia: a comprehensive review and 2016 update'. De Kouchkovsky, I., Abdul-Hay, M.[2022]

In a study of 53 acute myeloid leukemia (AML) patients who did not achieve complete remission after standard treatment, the median overall survival was only 3.9 months, highlighting the poor prognosis for primary resistant AML.

Key pretreatment factors such as patient age, comorbidities, ECOG performance status, leukocytosis, hepatomegaly, lactate dehydrogenase levels, and disease cytogenetics significantly influenced survival outcomes, which could aid in predicting prognosis and guiding future treatment decisions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pretreatment prognostic factors for overall survival in primary resistant acute myeloid leukemia. Colovic, N., Tomin, D., Vidovic, A., et al.[2015]

The standard treatment for acute myeloid leukemia (AML), known as '3 + 7' (daunorubicin and cytarabine), has not changed in 44 years and remains the primary induction regimen, but it has a high relapse rate and often leads to resistance in patients.

Genetic risk stratification is crucial for identifying patients who may not respond well to '3 + 7', suggesting that these patients should be considered for clinical trials to explore newer, more effective treatment options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cytarabine and daunorubicin for the treatment of acute myeloid leukemia. Murphy, T., Yee, KWL.[2018]

Recent advancements in acute myeloid leukemia (AML) treatment have introduced new drugs like gemtuzumab and midostaurin, which are more effective for specific AML subtypes, challenging the traditional '3+7' chemotherapy approach.

While lower intensity therapies show high response rates, they are less effective at preventing relapses, and the only curative option for poor-risk AML remains allogeneic stem cell transplant, indicating that '3+7' still plays a crucial role in combination therapies for suitable patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

3+7 Combined Chemotherapy for Acute Myeloid Leukemia: Is It Time to Say Goodbye? Tang, K., Schuh, AC., Yee, KW.[2022]

Acute myeloid leukemia (AML) is a group of aggressive diseases where prognosis and treatment depend on the specific genetic characteristics of the cancer, highlighting the importance of genetic evaluation in managing AML.

This review aims to inform pathologists about the current standards in genetic assessment for AML and to discuss future directions for improving classification and management of the disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute Myeloid Leukemia Genetics: Risk Stratification and Implications for Therapy. Wang, ML., Bailey, NG.[2022]

A patient with secondary acute myeloid leukemia and severe liver dysfunction (bilirubin >15 mg/dL) successfully received a modified high-dose cytarabine regimen, suggesting potential for safe treatment in similar cases.

This case highlights the need for further research on the safety and efficacy of cytarabine in patients with severe hepatic dysfunction, as traditional treatment regimens are often not viable for these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Successful use of high-dose cytarabine in a patient with acute myeloid leukemia and severe hepatic dysfunction. Barker, JA., Marini, BL., Bixby, D., et al.[2018]

Acute myeloid leukemia (AML) has the lowest survival rate among leukemias, particularly affecting elderly patients, highlighting the urgent need for new treatment strategies.

Emerging therapies such as Gemtuzumab ozogamicin for CD33-positive AML and selective FLT3 inhibitors show promise in improving survival rates, indicating potential advancements in the management of this challenging disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Epidemiology and clinical burden of acute myeloid leukemia. Redaelli, A., Lee, JM., Stephens, JM., et al.[2007]

In a phase 2 trial involving 57 patients with acute myeloid leukemia (AML) or high-grade myelodysplastic syndrome, alisertib showed a 17% response rate in AML patients, with one complete response lasting over a year and 49% achieving stable disease.

The treatment was associated with significant adverse events, including diarrhea, fatigue, and nausea, indicating that while alisertib has some efficacy in AML, its safety profile needs careful consideration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An exploratory phase 2 study of investigational Aurora A kinase inhibitor alisertib (MLN8237) in acute myelogenous leukemia and myelodysplastic syndromes. Goldberg, SL., Fenaux, P., Craig, MD., et al.[2021]

Gemtuzumab ozogamicin (Mylotarg) has been approved for treating acute myeloid leukemia (AML) in patients aged 15 and older, showing significant improvements in event-free survival and reduced relapse risk based on a meta-analysis of 3,325 patients.

While Mylotarg is effective, it is associated with common side effects such as hemorrhage and infection, particularly when used in combination with other chemotherapy drugs like daunorubicin and cytarabine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The EMA Review of Mylotarg (Gemtuzumab Ozogamicin) for the Treatment of Acute Myeloid Leukemia. Ali, S., Dunmore, HM., Karres, D., et al.[2020]

Recent advances in immunotherapy for acute myeloid leukemia (AML) include various strategies such as adoptive cellular therapies, checkpoint inhibitors, and vaccines, showing promise in early-phase trials.

Immunotherapy is particularly beneficial for patients with AML who are ineligible for transplants or have minimal residual disease, despite challenges like varying antigen expression and potential side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advances in immunotherapy for acute myeloid leukemia. Przespolewski, A., Szeles, A., Wang, ES.[2018]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06068868

NCT06068868 | Study to Evaluate Adverse Events and ... This study is to evaluate how safe ABBV-787 is and how it moves within the body in adult participants with relapsed/refractory (R/R) acute myeloid leukemia (AML) ...

2. abbvieclinicaltrials.com abbvieclinicaltrials.com/study/?id=M23-477

M23-477 Study to evaluate adverse events and movement of intravenously (IV) infused ABBV-787 in adult participants with relapsed/refractory (R/R) acute myeloid ...

3. jcto.weill.cornell.edu jcto.weill.cornell.edu/open_clinical_trials/a-phase-1-first%E2%80%91in%E2%80%91human-study-evaluating-safety-pharmacokinetics-and-efficacy-of-abbv%E2%80%91787-in-adult-subjects-with-acute-myeloid-leukemia-aml

A Phase 1 first‑in‑human study evaluating safety, ... The purpose of this study is to see if ABBV-787 (the study drug) is safe and to determine if ABBV-787 has an effect on relapsed or refractory (R/R) Acute ...

4. sparkcures.com sparkcures.com/trial/2001/NCT06068868

Multiple Myeloma Support + Trials This study is to evaluate how safe ABBV-787 is and how it moves within the body in adult participants with relapsed/refractory (R/R) acute myeloid leukemia (AML) ...

5. pharmaceutical-technology.com pharmaceutical-technology.com/data-insights/abbv-787-abbvie-refractory-acute-myeloid-leukemia-likelihood-of-approval/

ABBV-787 by AbbVie for Refractory Acute Myeloid Leukemia According to GlobalData, Phase I drugs for Refractory Acute Myeloid Leukemia have a 68% phase transition success rate (PTSR) indication ...

6. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06068868/study-to-evaluate-adverse-events-and-movement-of-intravenously-iv-infused-abbv-787-in-adult-participants-with-relapsed-refractory-rr-acute-myeloid-leukemia-aml

Study to Evaluate Adverse Events and Movement of ... This study is to evaluate how safe ABBV-787 is and how it moves within the body in adult participants with relapsed/refractory (R/R) acute ...

7. synapse.patsnap.com synapse.patsnap.com/drug/dfa935a5bc7f4e099476e425df5d4fae

ABBV-787 - Drug Targets, Indications, Patents A Phase 1 First-in-Human Study Evaluating Safety, Pharmacokinetics and Efficacy of ABBV-787 in Adult Subjects With Acute Myeloid Leukemia (AML)