APG-1387 in Patients With Advanced Solid Tumors or Hematologic Malignancies

  • STATUS
    Recruiting
  • days left to enroll
    27
  • participants needed
    90
  • sponsor
    Ascentage Pharma Group Inc.
Updated on 4 October 2022

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 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.

Details
Condition Advanced Solid Tumors or Hematologic Malignancies
Treatment APG-1387 for Injection
Clinical Study IdentifierNCT03386526
SponsorAscentage Pharma Group Inc.
Last Modified on4 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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 Criteria

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
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