APG-1387 in Patients With Advanced Solid Tumors or Hematologic Malignancies
Completed · Phase 1
Conditions studied: Advanced Solid Tumors or Hematologic Malignancies
In brief
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 xenograft models, APG-1387 also demonstrates its synergistic effect in combination with immune checkpoint inhibitor anti-PD-1 antibody, and such a combinatory effect was further enhanced by chemotherapeutic agent. A total of 35 patients with advanced solid tumors or lymphomas have been treated with APG-1387 in two Phase I dose-escalation studies in Australia and in China. Ten dose levels have been tested ranging from 0.3 mg to 45 mg in these two studies. Based on the preliminary results, APG-1387 is well-tolerated at the dose levels evaluated to date. APG-1387 is intended for the treatment of patients with advanced solid tumors and hematologic malignancies. After establishing the maximum tolerated dose (MTD), dose-limiting toxicities (DLTs), and/or recommended phase 2 dose (RP2D), several Ib /II studies will be implemented accordingly to further access the antitumor effects of APG-1387 in combination with either pembrolizumab or the chemotherapeutic agents.
Key facts
- Study ID
- NCT03386526
- Run by
- Ascentage Pharma Group Inc.
- People needed
- 90
- Starts
- 2017-11-21
- Expected to finish
- 2022-11-30
- Last updated by the study team
- 2023-02-01
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- University of Michigan — Ann Arbor, Michigan, United States
- START Midwest — Grand Rapids, Michigan, United States
- The START Center for Cancer Care — San Antonio, Texas, United States
Full record on ClinicalTrials.gov
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