Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

All Drugs and Chemicals

Amino Acids

Abivertinib

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

Phase I Arm 1: AC0010MA orally taking once daily, starting from 100 mg per day.

Phase I Arm 2: AC0010MA orally taking twice daily, starting from 200 mg per day (100 mg BID). Arm 2 will be initiated once the drug plasma t1/2 is 10 hours or below in the first dose cohort (100 mg QD).

Following Phase I, a protocol amendment will be submitted to the IND to specify the selected dose and dose justification to be used in Phase II.

AC0010MA

Vali A. Papadimitrakopoulou, MD

Suresh S. Ramalingam, MD

Heather Wakelee, MD

Karen L Reckamp, MD

AC0010MA is a new, irreversible, Epidermal Growth Factor Receptor (EGFR) mutation selective Tyrosine Kinase Inhibitor. Aim at local advanced or metastatic non-small cell lung cancer patients with EGFR mutation or T790M drug-resistant mutation. The molecular mechanism: by irreversible combining the EGFR-RTKs ATP binding site of cell, selectively suppress the activities of EGFR tyrosine kinase phosphorylation, block the signal transduction pathway of EGFR and inhibit the function of ras/raf/MAPK downstream, thus block the tumor cell growth by EGFR induction, and promotes apoptosis. AC0010MA Maleate Capsules has three characters: 1. Irreversible binding to EGFR; 2. Effectively suppresses the tumor cell with EGFR mutant while has no suppression to EGFR wild-type cell; 3. Efficient suppress the tumor cell with EGFR T790M drug-resistant mutation.

Safety, Pharmacokinetic and Preliminary Efficacy Study of AC0010MA in Advanced Non Small Cell Lung Cancer

A Phase I, Multicenter, Open-Label Safety, Pharmacokinetic and Preliminary Efficacy Study of Wild-type Sparing EGFR Inhibitor, AC0010MA, in Adult Patients With Previously Treated EGFRmut and Acquired T790M Mutation Non-Small Cell Lung Cancer (NSCLC)

To determine the safety and tolerability and to establish the maximum tolerated dose (MTD) of AC0010MA by incidence of dose limiting toxicity (DLT), defined as Grade 3 or 4 adverse events (AEs) and clinical lab abnormalities occurring within the first 28 days of treatment.

To characterize tumor response (objective response rate, ORR) and duration of response of AC0010MA as a criterion for further development of AC0010MA in this patient population.

To evaluate pharmacokinetic parameter of AC0010MA

ACEA Therapeutics, Inc.

Blood and Lymph Conditions

Immune System Diseases

Rare Diseases

Lymphoma

Lymphoma, B-Cell

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphoma, Non-Hodgkin

Lymphosarcoma

B-cell Lymphoma

This is dose escalation study. Patients will receive AC0010MA 200mg bid,300mg bid,400mg bid or 500mg bid by mouth (the dose escalation whether ended depends on DLT and occupancy) everyday until intolerable toxicity or disease progression

Participants in the dose escalation cohorts will be treated with AC0010MA every 28 days

Wanhong Xu, PhD

Bei Hu, PhD

Jie Jin, MD

This is an open label, dose escalation, phase I study to determine the recommended Phase 2 dose (PR2D) by assessing the DLT, safety and efficacy of AC0010 in patients with B-cell lymphoma.

This is an open label, dose escalation, phase I study to determine the PR2D by assessing the DLT, safety and efficacy of AC0010 in patients with B-cell lymphoma. This study includes two parts. During Part 1 Dose Escalation, the "3+3" design will be applied. Dose escalation will begin at dose level 1 = 400 mg. This dose escalation will be followed by an exploratory expansion phase in 3 or 4 groups of 15\~41 patients each (CLL group, MCL group, non-germinal center B cell-like DLBCL group, and/or FL/WM(macroglobulinemia) group). The study will further evaluate the safety and efficacy of AC0010 in these patients in each group

A Phase I Study of AC0010 in Patients With CLL/ SLL, MCL, DLBCL and Other NHL

A Phase I Study of AC0010 in Patients With Relapsed or Refractory CLL/SLL, MCL, DLBCL and Other Non-Hodgkin B-Cell Lymphoma

Determine the recommended phase II dose (RP2D) of AC0010 in patients with relapsed or refractory CLL/SLL, MCL, DLBCL and other Non-Hodgkin B-Cell lymphoma

AC0010 occupancy of the Bruton's tyrosine kinase (BTK) active site up to 24 hours

Evaluation of tolerability of AC0010 measured by number, nature and severity of Adverse Events using CTCAE Version 4.03

Evaluation of tolerability of AC0010 measured by number of subjects with dose limiting toxicities (DLTs)treatment

Maximum Tolerated Dose (MTD) as measured by the number of dose-limiting toxicities in each dose level

AC0010 occupancy of the BTK active site after continued treatment

Safety and efficacy data will take place at the analysis time point

Determine peak plasma concentration (Cmax) after oral administration of AC0010

Time to reach maximum observed plasma concentration

Area under the curve from time zero to the last quantifiable concentration

Area under the curve from time zero to extrapolated infinity

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Safety, Pharmacokinetic and Preliminary Efficacy Study of AC0010MA in Advanced Non Small Cell Lung Cancer	NCT02448251	Non Small Cell ...	AC0010MA	18 Years -	ACEA Therapeutics, Inc.
A Phase I Study of AC0010 in Patients With CLL/ SLL, MCL, DLBCL and Other NHL	NCT03060850	B-cell Lymphoma	AC0010MA	18 Years - 75 Years	Hangzhou ACEA Pharmaceutical Research Co., Ltd.

Spots Global Cancer Trial Database for ac0010ma

Every month we try and update this database with for ac0010ma cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for ac0010ma

Every month we try and update this database with for ac0010ma cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for ac0010ma cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.