Combining ICP-248 with Azacitidine for treating Acute Myelogenous Leukemia

A Phase 1 Study of ICP-248 in Combination With Azacitidine for the Treatment in Patients With Myeloid Malignancies.

This study is testing whether a new drug called ICP-248, when combined with azacitidine, can safely help people with Acute Myelogenous Leukemia feel better and improve their treatment outcomes.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 266 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Beijing InnoCare Pharma Tech Co., Ltd. (Industry-sponsored)
• Drugs / interventions: chemotherapy
• Locations: 18 sites (New Haven, Connecticut and 17 other locations)
• Trial ID: NCT06656494 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety, tolerability, pharmacokinetics, and preliminary efficacy of ICP-248 in combination with azacitidine in patients with Acute Myelogenous Leukemia (AML). The study is divided into two parts: a dose escalation period followed by a dose expansion period. It aims to determine the optimal dosing and effectiveness of the treatment in both treatment-naïve and previously treated relapsed/refractory AML subjects.

Who should consider this trial

Good fit: Ideal candidates include treatment-naïve AML patients aged 60 and older or younger patients with specific co-morbidities that make them unfit for intensive chemotherapy.

Not a fit: Patients with acute promyelocytic leukemia (APL) or those who do not meet the eligibility criteria will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with Acute Myelogenous Leukemia, potentially improving outcomes and survival rates.

How similar studies have performed: While this approach is novel in the context of combining ICP-248 with azacitidine, similar studies have shown promise in treating AML with other combinations.

Eligibility criteria

Inclusion Criteria:

Eligible subjects must meet all of the following criteria:

1. Subject must have confirmation of diagnosis of AML (except for acute promyelocytic leukemia \[APL\]) or MDS per 2016 World Health Organization (WHO) criteria.
2. For AML (except for APL) cohort:

   1. Previously treated relapsed/refractory AML subjects
   2. Treatment-naïve AML subjects should be: ≥60 years of age OR ≥18 years and \<60 years will be eligible if the subject has at least one of the following co-morbidities, which make the subject unfit for intensive chemotherapy
3. For MDS cohort: Adult TN MDS and R/R MDS: revised International Prognostic Scoring System (IPSS-R) score \> 3 and bone marrow blasts ≥ 5%.
4. Subject must have a projected life expectancy of at least 12 weeks.
5. Subject must have adequate renal function as demonstrated by a creatinine clearance ≥ 30 mL/min; determined via urine collection for 24-hour creatinine clearance or by the Cockcroft-Gault formula.
6. Subject must have adequate liver function

Exclusion Criteria:

1. R/R AML or R/R MDS with no response or intolerance to post azacitidine or BCL-2i.
2. Subject has acute promyelocytic leukemia (French-American-British Class M3 AML) .
3. Subject has known central nervous system (CNS) leukemia.
4. Suggest patients with active hepatitis B or C virus infection
5. History of immunodeficiency, including a positive human immunodeficiency virus (HIV) antibody test.
6. Subjects have another active malignancy within the past 2 years before study entry, except for curatively treated.

Where this trial is running

New Haven, Connecticut and 17 other locations

• Yale University, Yale Cancer Center — New Haven, Connecticut, United States (Recruiting)
• NYU Langone Health — New York, New York, United States (Recruiting)
• St Vincent's Hospital — Sydney, New South Wales, Australia (Recruiting)
• Royal Perth Hospital — Perth, Western Australia, Australia (Recruiting)
• Anhui Provincial Hospita — Hefei, Anhui, China (Recruiting)
• Peking University People's Hospital — Beijing, Beijing Municipality, China (Recruiting)
• The First Affiliated Hospital of Chongqing Medical University — Chongqing, Chongqing Municipality, China (Recruiting)
• Guangdong Provincial People's Hospital — Guangzhou, Guangdong, China (Recruiting)
• Nanfang Hospital Southern Medical University — Guangzhou, Guangdong, China (Recruiting)
• Henan Cancer Hospital — Zhengzhou, Henan, China (Recruiting)
• Union Hospital Tongji Medical College Huazhong University of Science and Technology — Wuhan, Hubei, China (Recruiting)
• The First Affiliated Hospital of Soochow University — Suzhou, Jiangsu, China (Recruiting)
• The First Affiliated Hospital of Nanchang University — Nanchang, Jiangxi, China (Recruiting)
• The First Hospital of Jilin University — Changchun, Jilin, China (Recruiting)
• Shengjing Hospital of China Medical University — Shengyang, Liaoning, China (Recruiting)
• Sichuan Provincial People's Hospital — Chengdu, Sichuan, China (Recruiting)
• Tianjin People's Hospital — Tianjin, Tianjin Municipality, China (Recruiting)
• The First Affiliated Hospital, Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (Recruiting)

Study contacts

• Study coordinator: Alexia Lu

Conditions Acute Myelogenous Leukemia; Myelodysplastic Syndromes