Clinical trial · Interventional
Clinical Trial of OPB-111077 in Patients With Relapsed or Refractory Acute Myeloid Leukaemia
Phase Ib Clinical Trial of OPB-111077 in Patients With Relapsed or Refractory Acute Myeloid Leukaemia
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Phase Ib, open-label, dose-escalation clinical trial to evaluate the best-tolerated doses in Acute Myeloid Leukaemia (AML) relapsed or refractory to chemotherapy. This open-label, nonrandomized trial will comprise 2 stages. A dose escalation stage will characterize the safety, tolerability and maximum tolerated dose (MTD), of OPB-111077. Subsequently, an expansion stage will further evaluate the safety and antitumor activity of OPB-111077 in AML relapsed or refractory to chemotherapy. Enrollment to the expansion cohort will begin following determination of the MTD. Approximately 6-12 patients will be included in the phase I part of this clinical trial. Additional patients will be included in the expansion cohort up to a total of 15 patients. The expansion cohort will serve to further evaluate safety simultaneously with preliminary efficacy. Patients will be selected and included in the study after testing the response to the drug with the Vivia Biotech ex vivo CDx PharmaFlow PM test. PharmaFlow PM test is a companion diagnostic (CDx) tool that provides a complete pharmacological profile for each individual, allowing the detection of patients resistant to OPB-111077 and enriching the study in patients that respond to the drug. The third of patients more sensitive to OPB-11077 wil be included in the study.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| OPB-111077 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- OPB-111077
- description
- Level 1: 200 mg daily Level 2: 250 mg daily
- interventionNames
- Drug: OPB-111077
Primary outcomes (1)
- measure
- Dose-limiting toxicity (DLT) of OPB-111077 in patients with in acute myeloid Leukemia.
- timeFrame
- 28 days
- description
- Any adverse event related to the study drug that occurred during the first cycle and considered relevant: * Any Grade 3 or 4 non-hematologic toxicity * Any unexpected non-tolerable grade II adverse event possibly related to the treatment regimen that requires delay beyond 1 week until recovery * Hematological toxicity is not considered doses limiting due to the characteristic of Acute Myeloid Leukemia.
Secondary outcomes (6)
- measure
- Overall response rate.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients at least 18 years old. * Patients diagnosed of non M3 acute myeloid leukemia in relapse after intensive chemotherapy. * Patients with a highest sensitivity (higher 70% of the samples analyzed) in the bone marrow analysis of the OPB-111077 ex-vivo sensitivity test. * Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2. * Bilirubin ≤ 2 × Upper Limit of Normal (ULN). For subjects with known Gilbert's disease, bilirubin ≤ 3.0 mg/dL. * Serum creatinine ≤2 × ULN or creatinine clearance (CrCl) ≥ 40 mL/min. * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN. * Left Ventricular Ejection Fraction (LVEF) must be equal to or greater than 50%. * New York Heart Association (NYHA) congestive heart failure (CHF) class II or better. * Recovery from adverse effects of prior therapy at time of enrollment to ≤ Grade 1 (excluding alopecia). * Life expectancy ≥3 months * Patients, or appropriate designee, must be able to provide informed consent. Exclusion Criteria: * Individuals with a history of other malignancies. * Subject has uncontrolled intercurrent illness that would limit compliance with study requirements. * Patients diagnosed of M3/Acute promyelocytic leukemia (APL). * The subject has received systemic antineoplastic therapy within 14 days of study treatment. * The subject has received any investigational agent within 28 days before the first dose of study treatment. * The subject has not recovered to baseline or CTCAE ≤ Grade 1 from toxicity due to all prior therapies except alopecia and other non-clinically significant Adverse Events (AEs). * The subject has concurrent uncompensated hypothyroidism or thyroid dysfunction within 7 days before the first dose of study treatment. * Gastrointestinal disorders particularly those associated with a high risk of perforation or fistula formation. * Malabsorption syndrome. * Subject is unable to swallow capsules or tablets. * Subject is pregnant or breastfeeding. * Patients with history of allergic reactions attributed to components of OPB- 111077 that are not easily managed * Subject has systemic infection requiring IV antibiotic therapy within 7 days preceding the first dose of study drug, or other severe infection. * Uncontrolled intercurrent illness that would limit compliance with study requirements. * Patients with serious medical or psychiatric illness likely to interfere with participation in this clinical study.
References
Publications (0)
Data not yet available