Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||18 Years and Over|
- - Histologically or cytologically confirmed myelofibrosis requiring therapy including: 1.
- - Patients must be ineligible or unwilling to undergo a stem cell transplantation or receive any other approved standard of care at the time of study entry.
- - Patients have been previously treated with a JAK inhibitor (JAKi) and are intolerant, resistant, refractory or lost response to the JAKi ruxolitinib or fedratinib, or had sub-optimal response to ruxolitinib.
- - Eastern Cooperative Oncology Group (ECOG) performance score of 0-2.
- - Adequate bone marrow function: 1.
- - Adequate renal and liver function as indicated by: 1.
- - Willingness to use contraception method that is deemed effective by the investigator by female patients of child bearing potential (postmenopausal women amenorrhea for at least 12 months to be considered of non-childbearing potential) and males with partners of child bearing potential, throughout the treatment period and for at least three months following the last dose of study drug.
- - Ability to understand and willingness to sign a written informed consent form.
- - Willingness and ability to comply with study procedures and follow-up examination.
- - Received standard or experimental therapy within 14 days or 5 half-lives (whichever is greater) before starting study therapy.
- - Previously received other B-cell lymphoma-extra large (Bcl-xL) inhibitors.
- - Receiving concomitant anticancer therapy, except hormonal therapy and patients on ruxolitinib.
- - Disease associated with myelofibrosis such as metastatic carcinoma, lymphoma, myelodysplasia, hairy cell leukemia, mast cell disease or acute leukemia.
- - Radiation within 14 days of study entry, thoracic radiation within 28 days of study entry.
- - Has gastrointestinal conditions that could affect the absorption of oral medication.
- - Has known active central nervous system (CNS) involvements.
- - Lack of toxicity recovery from previous therapy ≤ grade 1 or baseline (except alopecia, hemoglobin, neutropenia and thrombocytopenia) - Use of therapeutic anticoagulants.
- - Failure to recover adequately, as judged by the investigator, from prior surgical procedures.
- - Unstable angina, or other significant cardiac condition including: 1.
- - Active infection requiring systemic antibiotic/ antifungal medication, known clinically active hepatitis B or C infection, or on antiretroviral therapy for HIV disease.
- - Uncontrolled concurrent illness including, but not limited to: psychiatric illness/social situations that would limit compliance with the study requirements or any other condition or circumstance that would, in the opinion of the investigator, make the patient unsuitable for participation in the study.
- - Women who are pregnant, breast feeding or women of child-bearing potential (WOCBP) not using an effective method of birth control.
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
|Phase 1/Phase 2|
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|Ascentage Pharma Group Inc.|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Yifan Zhai, MD, PhD|
|Principal Investigator Affiliation||Ascentage Pharma Group Inc.|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
Part 1 will evaluate safety of APG-1252 monotherapy using a 3+3 dose escalation study design. The starting dose of APG-1252 monotherapy will be 160 mg administered as an intravenous injection over 30 minutes once weekly in a 28-day cycle. If the APG-1252 at 160 mg is tolerated (0/3 and ≤ 1/6 DLTs), dose escalation to 240 mg will be evaluated and declared as recommended phase 2 dose (RP2D) if tolerated. No doses higher than 240 mg once per week will be explored. If the 160 mg once weekly dose schedule is not tolerated (≥ 2/3 or ≥ 2/6 DLTs) de-escalation to 80 mg once weekly dose will be explored. No doses under 80 mg of APG-1252 will be explored as monotherapy. Maximum tolerated dose (MTD)/RP2D is defined as the highest dose with ≤ 1/6 patients with dose limiting toxicities. A maximum of 6 patients will be treated at the APG-1252 monotherapy dose level to further characterize safety. Part 2 will commence once APG-1252 monotherapy MTD/RP2D is determined following review of safety and tolerability of APG-1252 monotherapy and discussion between sponsor and investigators. In Part 2, APG-1252 will be tested in combination with ruxolitinib. Part 2 will evaluate tolerability and clinical benefit of the combination APG-1252 plus ruxolitinib using a 3+3 dose escalation design. Patients starting APG-1252 treatment as an addition to ruxolitinib should have been on ruxolitinib daily dose for at least 5 days at the same dose. If they were on fedratinib they should discontinue fedratinib and switch to ruxolitinib for at least 5 days before the addition of APG-1252. The starting dose of APG-1252 in Part 2, will be one dose level lower than the MTD of APG-1252 as monotherapy (i.e, at 80 mg if MTD is 160 and 160 mg if MTD is 240 mg) and will be increased to a maximum of 240 mg once per week, added to ruxolitinib. Once the MTD/RP2D of combination arm is determined, additional patients up to a maximum of 15 will be treated at the RP2D to further evaluate safety and clinical benefit.
Experimental: APG-1252 + Ruxolitinib
Drug: - APG-1252
infusion once weekly
Drug: - Ruxolitinib
taken orally twice a day
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.