A Phase 1/2 interventional study of AC0010 in Metastatic Non-small Cell Lung Cancer, sponsored by Hangzhou ACEA Pharmaceutical Research Co., Ltd.. Status unknown at 17 sites in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2021-09-10.
Sponsored by Hangzhou ACEA Pharmaceutical Research Co., Ltd. · Phase 1/2, Interventional, and Treatment
AC0010 is a novel, potent, small molecule irreversible tyrosine kinase inhibitor (TKI) that selectively targets mutant forms of the epidermal growth factor receptor (EGFR) while sparing wild-type (WT) EGFR. The purpose of the study is to evaluate the pharmacokinetic (PK) and safety profile of oral AC0010; to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of oral AC0010; to assess the safety and efficacy of AC0010 in previously treated mutant EGFR in NSCLC patients with EGFR T790M mutation.
Lung cancer remains the most common cancer worldwide with non-small cell lung cancer (NSCLC) accounting for 85% of cases. Molecularly targeted therapies have proven to be superior to chemotherapy for NSCLC patients whose tumors have mutations in EGFR. Recent studies have established tyrosine kinase inhibitors (TKIs) as the gold standard for treating EGFR-mutation-positive NCSLC. However, patients on TKIs eventually progress, and in approximately 50% of cases, progression is due to development of an additional mutation called T790M. AC0010 may provide an effective therapy for a patient population with few alternative treatment options. Pre-clinical data demonstrated that AC0010 inhibits T790M. It is anticipated that AC0010 may promote cell death in tumor cells with the T790M mutation, thus providing possible therapeutic benefit in patients who have developed T790M-mediated resistance to previous TKIs.
This is a two-part, open-label study of oral AC0010 administered twice-daily in previously treated NSCLC patients who have documented evidence of an activating mutation in the EGFR gene and have failed treatment with an EGFR inhibitor such as erlotinib, gefitinib or afatinib.
This study will include 2 parts:
phase 1 : Dose-escalation Period with 28-day cycles; Optional Treatment Extension Period starting on Day 29
phase 2 : Evaluation of activity and safety in patients with the EGFR T790M mutation
7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.
This study's enrollment of 368 is above the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →Hangzhou ACEA Pharmaceutical Research Co., Ltd. is the lead sponsor of 7 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria - phase 1:
Exclusion Criteria - Phase 1:
Inclusion Criteria - Phase 2:
Exclusion Criteria - Phase 2:
Oral AC0010 monotherapy
Drug: AC0010
Phase 1: AC0010 will be administered in escalating dosages in a period of 28-day cycles. Phase 2: AC0010 will be administered twice-daily at RP2D.
Also known as: AC0010MA
ORR(Objective Response Rate)
To assess the overall objective response rate (ORR) of AC0010 in EGFR T790M mutation-positive patients with advanced non-small cell lung cancer (NSCLC).
Time frame: Every 6 weeks from time of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 11 months
DoR (Duration of Response)
To assess the duration of response (DOR) of AC0010 in EGFR T790M mutation-positive patients with advanced non-small cell lung cancer (NSCLC).
Time frame: Every 6 weeks from time of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 11 months
PFS (Progression-free survival)
To assess the progression-free survival (PFS) of AC0010 in EGFR T790M mutation-positive patients with advanced non-small cell lung cancer (NSCLC).
Time frame: Every 6 weeks from time of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 11 months
DCR (Disease control rate)
To assess the disease control rate (DCR) of AC0010 in EGFR T790M mutation-positive patients with advanced non-small cell lung cancer (NSCLC).
Time frame: Every 6 weeks from time of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 11 months
OS (Overall survival)
To assess the overall survival (OS) of AC0010 in EGFR T790M mutation-positive patients with advanced non-small cell lung cancer (NSCLC).
Time frame: Every 6 weeks from time of first dose until objective disease progression, then every 3 months until death of lost of follow-up, up to approximately 18 months
EORTC QLQ-C30 and LC-13 questionnaire
To assess the safety of AC0010 in EGFR T790M mutation-positive patients with advanced non-small cell lung cancer (NSCLC).
Time frame: From screening to the end of survival follow-up, which is assessed though study completion
Adverse events
To assess the safety of AC0010 in EGFR T790M mutation-positive patients with advanced non-small cell lung cancer (NSCLC).
Time frame: From screening to 30days after end of treatment, which is assessed through study completion
Plan to share: No
This study is status unknown, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.
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Hangzhou ACEA Pharmaceutical Research Co., Ltd.