Status:
COMPLETED
APG-1387 in Patients With Advanced Solid Tumors or Hematologic Malignancies
Lead Sponsor:
Ascentage Pharma Group Inc.
Conditions:
Advanced Solid Tumors or Hematologic Malignancies
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
APG-1387 is a potent, bivalent small-molecule Inhibitor of Apoptosis Protein (IAP) antagonist. APG-1387 has shown strong dose- and schedule-dependent antitumor activities in multiple human cancer xeno...
Eligibility Criteria
Inclusion
- Histologically or cytologically confirmed solid tumor or hematological malignancies
- Life expectancy ≥ 3 months
- Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2
- Corrected QT interval (QTc) ≤ 450 ms in males, and ≤ 470 ms in females
- Adequate hematologic function
- International normalized ratio (INR), prothrombin time (PT) or activated partial thromboplastin time (aPTT) ≤1.5 x upper limit of normal (ULN)
- Adequate renal and liver function
- Willingness to use contraception
- Ability to understand and willingness to sign a written informed consent form
- Willingness and ability to comply with study procedures and follow-up examination
- Have provided tissue for biomarker analysis from a newly or recently-obtained biopsy of a tumor lesion not previously irradiated
Exclusion
- Received chemotherapy within 21 days (42 days for nitrosoureas or mitomycin C) prior to entering the study
- Received hormonal, biologic (\< 2 half-lives), small molecule targeted therapies or other anti-cancer therapy within 21 days of study entry
- Radiation or surgery within 14 days of study entry, thoracic radiation within 28 days of study entry
- Has known active central nervous (CNS) metastases and/or carcinomatous meningitis. Patients who have received prior radiotherapy for previous brain metastasis must have discontinued steroids for 14 days prior to study entry and be clinically stable
- Continuance of toxicities due to prior radiotherapy or chemotherapy agents that do not recover to ≤ Grade 1 except alopecia
- Requirement for corticosteroid treatment, with the exception of megestrol, local use of steroid
- Use of therapeutic anticoagulants
- International normalized ratio (INR) or activated partial thromboplastin time (APTT) ≥ 1.5 x ULN
- Concurrent treatment with an investigational agent or device within 28 days prior to the first dose of therapy
- Unstable angina, myocardial infarction, or a coronary revascularization procedure within 180 days of study entry
- Neurologic instability per clinical evaluation due to tumor involvement of the central nervous system (CNS)
- History of Bell's palsy
- Active rheumatoid arthritis (RA), active inflammatory bowel disease, chronic infections, or any other disease or condition associated with chronic inflammation
- Active infection requiring systemic antibiotic/ antifungal medication
- Known or suspected Wilson's Disease
- Prior treatment with IAP inhibitors
- History of hypersensitivity to paclitaxel, or any therapeutic antibody
- Has an active autoimmune disease, or a documented history of autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents
- Is on chronic systemic steroid therapy
- Has received a live vaccine within 30 days prior to first dose
- Has had an allogeneic tissue/solid organ transplant, prior stem cell or bone marrow transplant
Key Trial Info
Start Date :
November 21 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 30 2022
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT03386526
Start Date
November 21 2017
End Date
November 30 2022
Last Update
February 1 2023
Active Locations (3)
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1
University of Michigan
Ann Arbor, Michigan, United States, 48109
2
START Midwest
Grand Rapids, Michigan, United States, 49503
3
The START Center for Cancer Care
San Antonio, Texas, United States, 78229