ORM-1153 for AML
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called ORM-1153 to determine its safety and potential effectiveness for people with Acute Myeloid Leukemia (AML). The focus is on AML cases where cancer cells express a specific protein known as CD123. Participants will receive ORM-1153 through an IV and must visit the clinic frequently in the first few months. This trial may suit those whose AML has returned or not responded to other treatments and who have the CD123 protein. As a Phase 1 trial, the research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.
Is there any evidence suggesting that ORM-1153 is likely to be safe for humans?
Research shows that ORM-1153 remains in the early stages of human testing. Currently, solid information on patient responses to ORM-1153 in clinical trials is unavailable. However, ORM-1153 targets a protein called CD123, found on certain cancer cells, and aims to help fight blood cancers like Acute Myeloid Leukemia (AML).
As a Phase 1 study, the main goal is to assess the safety of ORM-1153 and determine the appropriate dose. Since this is the first time this treatment is tested in humans, researchers closely monitor for any side effects or adverse reactions. This phase is crucial for understanding how well participants tolerate the treatment. Participants should be aware that these early trials often require frequent clinic visits to ensure safety.12345Why do researchers think this study treatment might be promising?
Researchers are excited about ORM-1153 for treating acute myeloid leukemia (AML) because it offers a novel approach compared to standard chemotherapy options like cytarabine and anthracyclines. Unlike these conventional treatments, ORM-1153 may have a unique mechanism of action that specifically targets cancer cells more effectively, potentially leading to fewer side effects. This focused targeting could mean improved outcomes and a better quality of life for patients battling AML.
What evidence suggests that ORM-1153 might be an effective treatment for AML?
Research has suggested that ORM-1153 could help treat Acute Myeloid Leukemia (AML). This new treatment targets a protein called CD123 on AML cancer cells. In lab tests, ORM-1153 demonstrated a strong ability to fight cancer cells and appeared safe for patients. ORM-1153 disrupts cancer cell functions, potentially leading to better treatment outcomes. Although these early findings are promising, more clinical trials, including this one, are necessary to confirm its effectiveness in people.678910
Are You a Good Fit for This Trial?
This trial is for people with acute myeloid leukemia (AML) whose cancer cells have the CD123 protein. Participants should be adults who are able to visit the clinic often and do not have other serious infections or health conditions that could interfere with the study.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive ORM-1153 as an infusion with frequent clinic visits during the first few months
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- ORM-1153
Trial Overview
The study is testing ORM-1153, an experimental drug given by IV infusion, to find a safe dose and see if it helps treat AML with CD123. This is an early-phase (Phase 1) safety-focused trial.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
All participants receive ORM-1153 in escalating dose cohorts in Phase 1 Dose Escalation.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Orum Therapeutics USA, Inc.
Lead Sponsor
Citations
1.
biopharmaboardroom.com
biopharmaboardroom.com/news/1/5295/orum-therapeutics-doses-first-patient-in-phase-1-trial-of-orm-1153.htmlOrum Therapeutics Doses First Patient in Phase 1 Trial of ...
“We have built a substantial preclinical data package for ORM-1153, and our task now is to establish how those findings translate clinically,” ...
2.
linkedin.com
linkedin.com/posts/pharma-industrial-india_investigational-orumtherapeutics-biotechnews-activity-7516098379693686784-Q7wVOrum Therapeutics starts phase 1 trial for ORM-1153 in ...
ORM-1153 demonstrating potent antitumor activity and a favorable safety profile in models of acute myeloid leukemia (AML), including those with ...
Orum Therapeutics Announces U.S. FDA Clearance of an ...
ORM-1153 has the potential to improve treatment efficacy and tolerability for patients with severe hematologic malignancies.”
Clinical outcomes of core binding factor acute myeloid ...
This study analyzed outcomes of CBF-AML with respect to higher-risk molecular and cytogenetic cohorts and treatment approaches. Methods: We identified 58 ...
5.
peptideandprotein.com
peptideandprotein.com/articles/orum-orm-1153-cd123-gspt1-degrader-antibody-conjugate-phase-1/Orum Doses Its First Patient With ORM-1153, an Antibody ...
ORM-1153 carries a molecular glue that engages the cereblon E3 ubiquitin ligase and redirects it onto GSPT1, a translation termination factor ...
ORM-1153 - Drug Targets, Indications, Patents
Phase 1 First-in-Human Multi-Region Clinical Trial of ORM-1153 in Participants With Relapsed or Refractory Acute Myeloid Leukemia (AML) or ...
Publications
ORM-1153: A Novel CD123-Targeting Degrader Antibody Conjugate with Proprietary GSPT1 Degrading Payload for the Treatment of Acute Myeloid Leukemia ( AACR ...
Orum moving CD123-targeted DAC into first-in-human ...
Orum Therapeutics receives FDA clearance for ORM-1153, a degrader-antibody conjugate for relapsed/refractory AML. First-in-human trial ...
Study of ORM-1153 in Acute Myeloid Leukemia (AML) With ...
... ORM-1153, will be a safe and possibly effective treatment option for participants with blood cancers such as Acute Myeloid Leukemia (AML) ...
Orum Therapeutics to present ORM-1153 preclinical study ...
ORM-1153 is designed to induce antitumor activity by selectively degrading target proteins within acute myeloid leukemia (AML) cells. It ...
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