Neoplasms

Digestive System Diseases

All Conditions

Skin and Connective Tissue Diseases

Rare Diseases

Gastrointestinal Stromal Tumors

Neoplasms, Connective Tissue

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

30 mg QOD(Minor subjects will be enrolled based on weight)

40 mg QOD(Minor subjects will be enrolled based on weight)

20 mg QOD (Minor subjects will be enrolled based on weight)

HQP1351 Orally, once every other day (QOD) for consecutive 4 weeks each cycle.

HQP1351

Yifan Zhai, M.D., Ph.D.

Ruihua Xu, Professor

Zhiwei Zhou, Professor

Yong Li, Professor

Xiangbin Wan, Professor

Ning Li, Professor

Kaixiong Tao, Ph.D

Xin Wu, Professor

Ye Zhou, Professor

This study is a Multi-center, Open-label Phase 1 Study to Determine the Recommend Phase 2 Dose (RP2D) and Evaluate PK/PD and preliminary Efficacy of HQP1351 in Patients With GIST or Other Solid Tumors.

The primary objective of this phase 1 study is to determine the RP2D of HQP1351 in patients with GIST or other solid tumors. The secondary objective is to assess the safety, tolerability, PK and preliminary anti-tumor activities of HQP1351 in Patients With GIST or Other Solid Tumors.

Patients will be randomized at 1:1:1 ratio into the three dose cohorts: 30 mg QOD, 40 mg QOD and 50 mg QOD.Non-randomized selected adult subjects will receive a 40 mg QOD dosing regimen. And the minor will be enrolled to the three dose cohorts: 20mg QOD, 30 mg QOD, 40 mg QOD according to the weight.

A Study of HQP1351 in Patients With GIST or Other Solid Tumors

A Phase I Study to Assess the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Properties of Oral HQP1351 in Patients With GIST or Other Solid Tumors.

Patients with HQP1351 treatment related adverse events (AE), serious adverse events (SAE) will be assessed according NCI CTCAE Version 4.03.

Response will be evaluated every 2 cycles (8 weeks), according to the revised RECIST Guideline, Version 1.1

HealthQuest Pharma Inc.

Ascentage Pharma Group Inc.

Blood and Lymph Conditions

Symptoms and General Pathology

Leukemia

Leukemia, Myeloid

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Hematologic Diseases

Myeloproliferative Disorders

Bone Marrow Diseases

Chronic Disease

Disease Attributes

Myeloid Leukemia

Chronic Graft Versus Host Disease

Chronic Myeloid Leukemia

Chronic Myeloproliferative Disorders

To investigate the absorption properties, as well as to evaluate the mass balance and elucidate the pathways of biotransformation after a single oral dose (30mg, 100µCi) of \[14C\] HQP1351 to healthy Chinese male subjects.

[14C] HQP1351

Feng Shao, Doctor

The objective of this study is to determine the mass balance and routes of excretion of total radioactivity after a single oral 30mg (100µCi) dose of \[14C\] HQP1351 given as a suspension. For further clinical development, human mass balance data are required to elucidate the absorption, metabolism, and excretion of HQP1351.

The Absorption, Metabolism and Excretion of [14C] HQP1351 in Humans

A Single-center, Open-label, Single-dose Phase I Study to Investigate the Absorption, Metabolism and Excretion of [14C] HQP1351 After a Single Oral 30mg (100µCi) Dose in Healthy Chinese Male Subjects

Use liquid scintillation counter to evaluate Radioactivity concentration of each blood and plasma sample

Use liquid scintillation counter to evaluate Radioactivity concentration of each urine sample

Use liquid scintillation counter to evaluate Radioactivity concentration of each feces sample

Calculate the total radioactivity in urine and feces based on the radioactivity concentration of each sample

To determine the plasma concentrations of HQP1351 with validated LC-MS/MS method for obtaining its pharmacokinetics parameters

According to CTCAE v5.0, the number and frequency of adverse events after a single dose of test drug were assessed.

Subjects in the group A will be given HQP1351 after fasting meal on Day 1. Then after a seven-day of cleaning time, subjects in the group A will be given HQP1351 after 30 minutes of high-fat meal on Day 8.

Subjects in the group B will be given HQP1351 after 30 minutes of high-fat meal on Day 1. Then after a seven-day of cleaning time, subjects in the group B will be given HQP1351 after fasting meal on Day 8.

Orally, single dose of 30mg on day 1 and day 8.

QIAN JIANG, Professor

The purpose of this study is to characterize the pharmacokinetics of HQP1351 in participants with resistant chronic myeloid leukemia (CML) in chronic phase (CP) after high-fat and fasting meals separately（Selection of high-fat meal spectrum：《The Food - Effect Bioavailability and Fed Bioequivalence Studies》high fat diet should be 800-1000 kcal heat.).

The drug being test in this study is HQP1351，the study will characterize the pharmacokinetics of HQP1351 in participants with resistant chronic myeloid leukemia（CML）in chronic phase（CP）after high-fat meal and fasting meal separately at a dose of 30mg，single-dose. The study will enroll 12 subjects totally and be randomly divided into 2 groups（A group and B group）. Every group will have 6 subjects. The experiment is divided into two periods，in period 1, subjects in the group A will be given HQP1351 30mg after fasting meal，and the group B will be given HQP1351 30mg after 30 minutes of high-fat meal. Then after a seven-day of cleaning time the two groups of subjects took the drug interchangeably in the period 2.

Pharmacokinetics Profiles of HQP1351 Under Fasting and High-fat Meals in Patients With Chronic Myeloid Leukemia

A Randomized, Open, Double-crossing Trial to Evaluate the Effect of Fasting or High-fat Meals on the Pharmacokinetics of Single Oral Administration of HQP1351 Tablets on an Empty Stomach or a High-fat Meal in Patients With Chronic Myeloid Leukemia

Area under the plasma concentration-time curve from time zero extrapolated to infinity time of HQP1351.

Area under the plasma concentration-time curve from time zero to the last measurable time point of HQP1351.

Percentage of area under the concentration time curve from time zero extrapolated to infinite time obtained by extrapolation of HQP1351.

Maximum observed plasma concentration of HQP1351.

Time to maximum observed plasma concentration of HQP1351.

Terminal elimination half life (T1/2) is defined as the duration until observation of half of the maximum concentration of HQP1351.

Apparent clearance of HQP1351 following oral dosing. Clearance of a drug is a measure of rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose of HQP1351 (apparent oral clearance) is influenced by the fraction of dose absorbed.

Apparent volume of distribution of HQP1351. Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution of HQP1351 after oral dose (Vz/F) is influenced by the fraction absorbed.

Incidence of toxicity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03

All Drugs and Chemicals

Antineoplastic Agents

Anti-Infective Agents

Antisickling Agents

Amino Acids

Nilotinib

Dasatinib

Interferons

Homoharringtonine

Tyrosine Kinase Inhibitors

Hydroxyurea

Imatinib Mesylate

Antiviral Agents

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

HQP1351 40 mg, taken orally once every other day of a 28-day cycle

Best available therapy (BAT) will be selected by the investigator for each participant.

HQP1351 is a new, bioavailable inhibitor against BCRABLWT and a broad spectrum of BCR-ABL mutants including BCR-ABLT315I

Patients will receive BAT based on the Investigator's opinion, taking into account the manufacturer's instructions, labeling, subject's medical condition, and institutional guidelines.

Hydroxyurea or Interferon-based therapy

Imatinib, Dasatinib or Nilotinib

Xiaojun Huang, Professor

The purpose of this study is to evaluate the efficacy of HQP1351 in patients with chronic myeloid leukemia in chronic phase (CML-CP) who are resistant and/or intolerant to first- and second-generation tyrosine kinase inhibitors. The efficacy of HQP1351 is determined by evaluating the subjects' event free survival (EFS).

This is a phase 2, randomized, open label, pivotal study to evaluate the efficacy and safety of HQP1351 in CML CP patients who are resistant and/or intolerant to first- and second-generation TKIs in China. A total of 141 CML CP patients will be included in this study. After screening, eligible subjects will be randomized by 2:1 ratio to enter HQP1351 therapy cohort and best available therapy (BAT) cohort. When the subjects in the two cohorts reach EFS assessment, they can crossover to contralateral cohort if the investigator and Sponsor think they could be clinically benefited. During treatment, each subject will be assessed regularly for hematological, cytogenetic and molecular responses. At the same time, safety information also will be evaluated.

A Pivotal Study of HQP1351 in Patients With Chronic Myeloid Leukemia in Chronic Phase

A Phase 2, Randomized, Open Label, Pivotal Study to Evaluate the Efficacy and Safety of HQP1351 in CML CP Patients Who Are Resistant and/or Intolerant to First- and Second-Generation Tyrosine Kinase Inhibitors

EFS is defined as any "event" occurred since randomization, such as disease progression.

CHR is the proportion of patients achieving CHR after being treated. It is defined as the best response obtained by the subjects during the whole treatment process of the study.

MCyR is the proportion of patients achieving Complete cytogenetic response (CCyR: defined as 0% Philadelphia chromosome-positive \[Ph+\] metaphases by cytogenetic analysis of bone marrow) or Partial Cytogenetic Response (PCyR: defined as \>0% to 35% Ph+ metaphases by cytogenetic analysis of bone marrow). It is defined as the best response obtained by the subjects during the whole treatment process of the study.

CCyR is the proportion of patients achieving CCyR after being treated. It is defined as the best response obtained by the subjects during the whole treatment process of the study.

MMR is the proportion of patients achieving a ratio of ≤0.1% breakpoint cluster region (BCR) abelson leukemia (ABL) to ABL transcripts on the international scale (≤0.1% BCR-ABL/ABL\[IS\]) after being treated with HQP1351. It is defined as the best response obtained by the subjects during the whole treatment process of the study.

PFS is defined as the interval between the first dose date and the first date at which the criteria for progression are met, or death. The subject who isn't progression or death will be censored at the last response assessment.

OS is defined as the interval between the first dose date and date of death, censored at the last contact date to be alive.

Adverse events (AEs), and serious AEs (SAEs): Patients treatment related AE, SAE will be assessed according NCI CTCAE Version 5.0.

Leukemia, Myeloid, Accelerated Phase

40 mg tablet, taken orally once every other day

Qian Jiang, Professor

The purpose of this study is to evaluate the efficacy of HQP1351 in patients with chronic myeloid leukemia in accelerated phase (CML-AP) harboring T315I mutation. The efficacy of HQP1351 was determined by evaluating the subjects' major hematologic response (MaHR).

This is an open, single-arm, multi-center phase 2 clinical study to evaluate the efficacy and safety of oral administrated of HQP1351(40mg, QOD) in CML-AP patients with T315I mutation in China. A total of 20 CML-AP patients will be included in this pivotal study. After screening, eligible subjects will receive oral HQP1351 40mg on a continues once every other day dosing regimen, until disease progression, drug intolerance, or meet other treatment conditions to discontinue the study. During the course of treatment, each subject will be assessed regularly for hematological, cytogenetic and molecular responses. At the same time, safety information also will be evaluated.

A Pivotal Study of HQP1351 in Patients of Chronic Myeloid Leukemia in Accelerated Phase With T315I Mutation

A Phase II Multi-center, Open Label Study of HQP1351 in Chinese Patients of Chronic Myeloid Leukemia With T315I Mutation in Accelerated Phase

During the course of HQP1351 therapy, the relationship between BCR-ABL1 kinase region/other mutations and drug resistance/disease progression will be measured.

Objects' quality of life will be measured during the course of HQP1351 therapy by European Organization for Research and Treatment (EORTC) quality of life questionnaire core-30 version3 \[QLQ-C30(V3) questionnaire\].

MaHR is the proportion of patients achieving Complete hematologic response (CHR) or no evidence of leukemia (NEL). It is defined as the best response obtained by the subjects during the whole treatment process of the study.

CHR is the proportion of patients achieving CHR after being treated with HQP1351. It is defined as the best response obtained by the subjects during the whole treatment process of the study.

CCyR is the proportion of patients achieving CCyR after being treated with HQP1351. It is defined as the best response obtained by the subjects during the whole treatment process of the study.

The time to response is defined as the interval between the first use of HQP1351 and the first date at which the criteria for response are met. The subject who isn't met the response criteria will be censored at the last assessment time.

Duration of response is defined as the interval between the first assessment at which the criteria for response are met until the earliest date at which the criteria for progression are met, and the subject who isn't met the progression criteria will be censored at the last assessment time. The duration of response is calculated only for subjects who achieved response.

PFS is defined as the interval between the first dose date of HQP1351 treatment and the first date at which the criteria for progression are met, or death. The subject who isn't progression or death will be censored at the last response assessment.

OS is defined as the interval between the first dose date of HQP1351 treatment and date of death, censored at the last contact date to be alive.

Patients with HQP1351 treatment related AE, SAE will be assessed according NCI CTCAE Version 5.0.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study of HQP1351 in Patients With GIST or Other Solid Tumors	NCT03594422	Gastrointestina... Solid Tumor, Ad...	HQP1351	12 Years -	Ascentage Pharma Group Inc.
The Absorption, Metabolism and Excretion of [14C] HQP1351 in Humans	NCT04126707	Chronic Myeloid...	[14C] HQP1351	18 Years - 50 Years	Ascentage Pharma Group Inc.
Pharmacokinetics Profiles of HQP1351 Under Fasting and High-fat Meals in Patients With Chronic Myeloid Leukemia	NCT03882281	Chronic Myeloid...	HQP1351	18 Years - 55 Years	Ascentage Pharma Group Inc.
A Pivotal Study of HQP1351 in Patients With Chronic Myeloid Leukemia in Chronic Phase	NCT04126681	Chronic Myeloid...	HQP1351 Hydroxyurea or ... Homoharringtoni... Imatinib, Dasat...	18 Years -	Ascentage Pharma Group Inc.
A Pivotal Study of HQP1351 in Patients With Chronic Myeloid Leukemia in Chronic Phase	NCT04126681	Chronic Myeloid...	HQP1351 Hydroxyurea or ... Homoharringtoni... Imatinib, Dasat...	18 Years -	Ascentage Pharma Group Inc.
A Pivotal Study of HQP1351 in Patients of Chronic Myeloid Leukemia in Accelerated Phase With T315I Mutation	NCT03883100	Chronic Myeloid...	HQP1351	18 Years -	Ascentage Pharma Group Inc.
Pharmacokinetics Profiles of HQP1351 Under Fasting and High-fat Meals in Patients With Chronic Myeloid Leukemia	NCT03882281	Chronic Myeloid...	HQP1351	18 Years - 55 Years	Ascentage Pharma Group Inc.
A Study of HQP1351 in Patients With GIST or Other Solid Tumors	NCT03594422	Gastrointestina... Solid Tumor, Ad...	HQP1351	12 Years -	Ascentage Pharma Group Inc.
Pharmacokinetics Profiles of HQP1351 Under Fasting and High-fat Meals in Patients With Chronic Myeloid Leukemia	NCT03882281	Chronic Myeloid...	HQP1351	18 Years - 55 Years	Ascentage Pharma Group Inc.

Spots Global Cancer Trial Database for hqp1351

Every month we try and update this database with for hqp1351 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 hqp1351

Every month we try and update this database with for hqp1351 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 hqp1351 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.