APG-2449 in Patients With Advanced Solid Tumors

  • STATUS
    Recruiting
  • End date
    Feb 26, 2025
  • participants needed
    150
  • sponsor
    Ascentage Pharma Group Inc.
Updated on 4 October 2022
cancer
tyrosine
measurable disease
brigatinib
lung cancer
kinase inhibitor
metastasis
esophageal cancer
ROS1
brain metastases
solid tumour
ovarian cancer
esophagus cancer
cancer, ovarian
cancer of the ovary
lung carcinoma
proto-oncogene tyrosine-protein kinase ros
alectinib

Summary

APG-2449 is a novel, orally active, multi-targeted tyrosine kinase inhibitor, which inhibits FAK, ALK, and ROS1 with nanomolar potencies. In preclinical studies, APG-2449 demonstrated potent antiproliferative activity in various cancer cell lines as a single agent. In combination treatment, APG-2449 enhanced anti-proliferative activities of several chemotherapeutic and targeted agents. It is indicated that APG-2449 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-2449 is intended for the treatment of patients with advanced 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.

Details
Condition Advanced Solid Cancer, Non Small Cell Lung Cancer, Esophageal Cancer, Ovarian Cancer, Malignant Pleural Mesothelioma
Treatment APG-2449
Clinical Study IdentifierNCT03917043
SponsorAscentage Pharma Group Inc.
Last Modified on4 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Dose exploration stage: non-small cell lung cancer diagnosed by histology and/or cytology and positive for ALK/ROS1 gene fusion (molecular diagnosis confirmed by the investigator) and malignant pleural mesothelioma, esophageal cancer and ovarian cancer. Kind of patients with advanced tumors
Expansion stage: cohort one, patients with non-small cell lung cancer who have
progressed or intolerable after the second-generation ALK TKI(Alectinib or
Ceritinib or Brigatinib or Ensartinib) or any ROSI TKI treatment; cohort two
ALK/ROS1 fusion gene positive without TKI treatment Patients with non-small
cell lung cancer. The molecular diagnosis results of the above patients can be
confirmed by the investigator
ECOG Performance Status ≤ 1
Expectation of life ≥ 3 months
According to RECIST version 1.1, there is at least 1 measurable lesion
Adequate hematologic and bone marrow functions
Adequate renal and liver function
Normal cardiac function
Brain metastases with clinically controlled neurologic symptoms
Serum pregnancy test results of women of childbearing age were negative within 7 days before taking the first dose of study drug
Men, women of childbearing age (postmenopausal women must have been menopausal for at least 12 months before they can be considered infertile) and their partners voluntarily take the study drug for at least 30 days after signing the informed consent form and taking the study drug as deemed effective by the investigator Contraceptive measures
Ability to understand and willingness to sign a written informed consent form
Subjects must be willing and able to complete the research procedures and follow-up inspections

Exclusion Criteria

Receiving concurrent anti-cancer therapy (chemotherapy, radiotherapy, immunotherapy, biologic therapy); or any investigational therapy within 28 days prior to the first dose of study drug
Continuance of toxicities due to prior therapy that do not recover (CTCAE V5.0 Grade> 1)
Obvious cardiovascular disease history
Failure to recover adequately, as judged by the investigator, from prior surgical procedures. Patients who have had major surgery within 28 days from study entry, and patients who have had minor surgery within 14 days of study entry
Active symptomatic fungal, bacterial and/or viral infection including, but not limited to, active human immunodeficiency virus (HIV) or viral hepatitis (B or C)
Receiving TKI therapy within 8 days prior to the first dose of study drug
Has difficulty in swallowing, absorbing barrier, or other diseases blocking APG-2449' taken
Known allergies to study drug ingredients or their analogs
Female subjects who are pregnant or breastfeeding, or expecting to become pregnant during the study period
According to the judgment of the investigator or sponsor, any symptoms or disease of the subject may endanger its safety or interfere with the safety assessment of the study drug
Subjects who have used CYP3A4, CYP2C9, or CYP2C19 moderately potent inhibitors or moderately potent inducers 1 week before receiving the study drug for the first time
Subjects who used CYP3A4 substrates and narrow treatment window 1 week before the first study drug
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