APG-2449 in Patients With Advanced Solid Tumors

STATUS

Recruiting
End date

Feb 26, 2025
participants needed

150
sponsor

Ascentage Pharma Group Inc.

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Updated on 4 October 2022

See if I qualify

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 Identifier	NCT03917043
Sponsor	Ascentage Pharma Group Inc.
Last Modified on	4 October 2022

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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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APG-2449 in Patients With Advanced Solid Tumors