Status and phase
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About
APG-1252 is a highly potent Bcl-2 family protein inhibitor, a promising drug candidate which shown high binding affinities to Bcl-2, Bcl-xL and Bcl-w. The preclinical studies have shown that APG-1252 alone achieves complete and persistent tumor regression in multiple tumor xenograft models with a twice weekly or weekly dose-schedule, including SCLC, colon, breast and ALL cancer xenografts; achieves strong synergy with the chemotherapeutic agents, indicating that APG-1252 may have a broad therapeutic potential for the treatment of human cancer as a single agent and in combination with other classes of anticancer drugs. APG-1252 is intended for the treatment of patients with SCLC or other solid tumors. Upon completion of the Phase 1 dose escalation study to establish the maximum tolerated dose (MTD), dose-limiting toxicities (DLTs), and/or recommended phase 2 dose (RP2D), several phase Ib/II studies will be implemented accordingly.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Histologically or cytologically confirmed small cell lung cancer (SCLC) or other solid tumors;
Male or non-pregnant, non-lactating female patients age ≥18 years;
Locally advanced or metastatic disease for which no standard therapy is judged appropriate by the investigator;
Eastern Cooperative Oncology Group (ECOG) Performance Status ≤2;
Adequate hematologic function as indicated by:
Adequate renal and liver function as indicated by:
Brain metastases with clinically controlled neurologic symptoms, defined as surgical excision and/or radiation therapy followed by 21 days of stable neurologic function & no evidence of CNS disease progression as determined by CT or MRI within 21 days prior to the first dose of study drug.
Willingness to use contraception by a method that is deemed effective by the investigator by both males and female patients of child bearing potential (postmenopausal women must have been amenorrheal for at least 12 months to be considered of non-childbearing potential) and their partners 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 (the consent form must be signed by the patient prior to any study-specific procedures);
Willingness and ability to comply with study procedures and follow-up examination.
Exclusion criteria
Primary purpose
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24 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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